Director of quality management work from home jobs - 169 jobs

Before we opened Strive Pharmacy we were unsatisfied with the current state of the pharmaceutical industry. Most of the current pharmaceuticals only offer a one size fits all approach and often come with unwanted and potentially dangerous side effects. We found that through compounding we can offer a much more personalized solution to medicine. Through this we have been able to help patients get the results they are seeking for their personal needs. After years of working for corporate chains we took the risk and opened Strive Pharmacy. We are dedicated to providing a better experience for each customer and clinic that we work with. Come see the Strive difference. Our Mission We're flipping the script with personal medicine. We strive to interrupt an industry that has been closed to personalized care, accessibility, and nuance for too long. We strive to shift a reactive view of self-care and ignite a proactive baseline-shifting approach to health for all. ‘The human element' is our crux and catalyst, driving all that we do, whether we're interacting with patients, providers, or practices. We're here to partner with those ready for a change. More than a compounding pharmacy, we're on a mission to positively disrupt healthcare as we know it. Strive is about more than medicine. Strive is about striving for the personal side of healthcare. Position Overview: The Vice President of Quality is a strategic and operational executive responsible for leading the design, implementation, and continuous improvement of the organization's Quality strategy and systems. This leader will ensure that products, processes, and facilities meet the highest standards of quality, safety, compliance, and customer trust. The VP of Quality oversees Quality Assurance, Quality Control, Quality Improvement, Validation, Document Control, and training functions, partnering closely with Operations, Supply Chain, and Enterprise teams to drive business excellence. Location: Remote Salary Range: $180,000 - $200,000 + Bonus Opportunity Key Responsibilities: Strategic Leadership Develop and lead a comprehensive Quality strategy aligned with organizational priorities and growth objectives. Build and scale world-class Quality Management Systems (QMS) that support operational reliability, regulatory excellence, and continuous improvement. Act as a key advisor to the Executive team on quality related risk, compliance health, and improvement opportunities. Champion a culture of quality, accountability, and proactive problem-solving across all levels of the organization. Execution & Delivery Compliance & Regulatory Ensure full compliance with applicable regulations such as FDA, cGMP, 21 CFR, USP, ISO standards, state board regulations, and other governing bodies relevant to the business. Lead preparation for and responses to regulatory inspections, customer audits, and certification activities. Oversee internal audit programs, CAPA management, risk assessments, product release processes, and validation activities. Operational Quality Management Lead Quality Assurance, Quality Control, training, and documentation teams to achieve performance, throughput, and reliability expectations. Establish and track Quality KPIs and dashboards (such as, complaint trends, deviation rates, batch failure rates, inspection outcomes). Collaborate with Operations and Supply Chain to drive defect reduction, process optimization, and preventive quality initiatives. Oversee product recall processes, quality incident investigations, root-cause analysis, and corrective actions. Organizational Leadership Develop talent, build bench strength, and create scalable organizational structures that support rapid growth. Manage budgets, staffing plans, and resource allocation across the Quality organization. Inspire and mentor teams, driving an environment of trust, integrity, performance, and accountability. Qualifications: Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, Chemistry, Biology, or related field. 15+ years of progressively responsible Quality leadership experience. Demonstrated success scaling Quality systems in a highly regulated environment. Deep expertise in cGMP, FDA regulations, ISO or equivalent industry standards. Proven track record leading audit readiness, compliance, and continuous improvement programs. Executive presence with strong communication, influence, and stakeholder alignment capability. Preferred Qualifications: Master's degree, MBA, or PharmD. Experience in pharmaceutical manufacturing, medical devices, biologics, or sterile compounding. Experience with digital QMS systems, Lean, Six Sigma, or operational excellence methodologies. Background leading multi-site, multi-state, or high-growth operations. Annual Salary$180,000-$200,000 USDBenefits/ Perks Strive Pharmacy provides a comprehensive benefits package that encompasses various perks such as employer paid healthcare coverage available after 30 days of employment, the choice of an FSA/HSA, a voucher for new hire scrubs (if applicable), parental leave, a 401(k) plan with matching contributions, and the benefit of weekends and holidays off. FREE COMPOUNDED MEDS to employees and immediate family members. Culture At Strive, culture plays a fundamental role in shaping our workplace atmosphere. Beyond our exceptional benefits package, we foster a sense of community. Throughout the year, we arrange various holiday potlucks and festive celebrations. Strive is committed to promoting both personal and professional development, striving for our employees to excel and grow in every aspect of their lives, both within and outside of the workplace. EEO Strive Pharmacy is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristics as outlined by federal, state or local laws. Disclaimer*** Please do not call the pharmacy location with questions about your application or interview. A talent acquisition partner will reach out to you.

About Invisible Invisible Technologies makes AI work. Our end-to-end AI platform structures messy data, automates digital workflows, deploys agentic solutions, measures outcomes, and integrates human expertise where it matters most. Our platform cleans, labels, and structures company data so it is ready for AI. It adapts models to each business and adds human expertise when needed, the same approach we have used to improve models for more than 80% of the world's top AI companies, including Microsoft, AWS, and Cohere. Our successes span industries, from supply chain automation for Swiss Gear to AI-enabled naval simulations with SAIC, and validating NBA draft picks for the Charlotte Hornets. Profitable for more than half a decade, Invisible reached $134M in revenue and ranked as the number two fastest growing AI company on the 2024 Inc. 5000. In September 2025, we raised $100M in growth capital to accelerate our mission of making AI actually work in the enterprise and to advance our platform technology. About The Role As a company redefining operations through AI innovation, our ability to deliver consistently high-quality outcomes is at the core of the value we provide to our clients. We are seeking a detail-oriented and impact-driven Delivery Quality Manager to ensure that our AI training and multilingual data operations maintain the highest standards of accuracy, consistency, cultural relevance, and linguistic excellence. In this role, you will work in close collaboration with some of the most influential organizations in generative AI and LLM development. You'll act as a quality guardian across our enterprise delivery programs-ensuring that our human-in-the-loop (HITL) workflows, advanced multilingual data generation processes, and high-touch client services operate at peak precision and reliability. You'll partner with Operations Managers, project leads, and client stakeholders to define and implement robust quality assurance protocols, drive performance improvements, and cultivate a culture of continuous enhancement across delivery teams. From proactive QA audits to root-cause analyses, you'll play a mission-critical role in maintaining the trust and satisfaction of some of the world's most forward-thinking AI labs and companies. This position requires an analytical mindset, a sharp eye for detail, and a passion for operational excellence. Success in this role means not only identifying problems-but creating scalable systems and frameworks to prevent them. You'll be on the front lines of building the standards that shape how human-generated data trains and improves the AI models of tomorrow. What You'll Do Cross-Functional Collaboration: Work closely with Delivery, Product, Engineering, and Customer Success teams to address quality concerns and build preventive measures. Process Optimization: Identify process inefficiencies or gaps in both AI data and multilingual pipelines, and work with relevant teams to streamline operations and improve delivery accuracy and speed. Reporting & Insights: Generate regular reports and insights on delivery performance trends, multilingual QA activities, and recommendations to leadership. Quality Assurance Strategy: Develop and implement comprehensive QA frameworks for large-scale AI data and multilingual delivery workflows, aligned with industry best practices and internal standards. Tooling & Automation: Evaluate and implement QA tools and automation frameworks to streamline quality checks and reduce manual errors across delivery pipelines. What We Need Bachelor's degree in Operations Management, Engineering, Computer Science, Linguistics, or related field. Proven expertise in language QA concepts and workflows, including linguistic quality assessment, cultural adaptation, and managing multilingual projects. 5+ years of experience in quality assurance, service delivery, or operations, preferably in a tech, localization or AI-focused environment. Deep understanding of delivery and multilingual lifecycles, QA methodologies, and performance metrics. Experience working in agile environments and using project management tools Strong analytical skills with experience in data-driven decision-making. Familiarity with AI/ML concepts and workflows is a strong plus. What's In It For You Invisible is committed to fair and competitive pay, ensuring that compensation reflects both market conditions and the value each team member brings. Our salary structure accounts for regional differences in cost of living while maintaining internal equity. For this position, the annual salary ranges by location are: Tier 1$132,000-$147,300 USDTier 2$120,000-$134,000 USDTier 3$108,000-$120,000 USD You can find more information about our geographic pay tiers here. During the interview process, your Invisible Talent Acquisition Partner will confirm which tier applies to your location. For candidates outside the U.S., compensation is adjusted to reflect local market conditions and cost of living. Bonuses and equity are included in offers above entry level. Final compensation is determined by a combination of factors, including location, job-related experience, skills, knowledge, internal pay equity, and overall market conditions. Because of this, every offer is unique. Additional details on total compensation and benefits will be discussed during the hiring process What It's Like to Work at Invisible: At Invisible, we're not just redefining work-we're reinventing it. We operate at the intersection of advanced AI and human ingenuity, pushing the boundaries of what's possible to unlock productivity and scale. Ownership is at the core of everything we do. Here, you won't just execute tasks-you'll build, innovate, and shape the future alongside world-class clients pushing the boundaries of AI. We expect bold ideas, relentless drive, and the ability to turn ambiguity into opportunity. The pace is fast, the challenges are big, and the growth is unmatched. We're not for everyone, and we're okay with that. If you're looking for predictable routines, this isn't the place for you. But if you're driven to create, thrive in dynamic environments, and want a front-row seat to the AI revolution, you'll fit right in. Country Hiring Guidelines: Invisible is a hybrid organization with offices and team members located around the world. While some roles may offer remote flexibility, most positions involve in-office collaboration and are tied to specific locations. Any location-based requirements or hybrid expectations will be communicated by our Talent Acquisition team during the recruiting process. AI Interviewing Guidelines: Our hiring team thoughtfully uses AI to support an efficient, engaging, and inclusive interview process. Since AI can also be a helpful tool for candidates, we've outlined expectations for using it ethically throughout your interview journey. Click here to learn more about how we use AI and our guidelines for candidates. Accessibility Statement: We're committed to providing reasonable accommodations for individuals with disabilities. If you need assistance or accommodation due to a disability, please contact our Talent Acquisition team during the recruitment process at accommodation@invisible.email . Equal Opportunity Statement: We're an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or veteran status, or any other basis protected by law. Due to a high volume of candidates, Invisible may use automated decision-maker technologies to filter candidates based on response to our application questions and other provided information. Our use of automated decision-making enables us to be efficient by providing a manageable list of possible candidates that meet our mandatory hiring criteria. If you object to our use of automated decision-making please contact us.

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. Responsible for leading the CLS Immunoassay Commercial Product Quality (CPQ) Team responsible for complaint handling, medical device reporting and Field Action activities for Atellica IM, Atellica CI and ADVIA Centaur assays. This role is responsible for developing and executing organizational strategies, processes, goals, and metrics that drive measurable improvements in complaint handling, product quality, and customer satisfaction. This role leads cross-functional initiatives to enhance the customer experience, reduce quality issues, and ensure compliance with regulatory and internal standards. This role is fully remote, preferably within US East Coast. Responsibilities Serving as a Subject Matter Expert for post market topics, processes and tools. Ensuring compliance with applicable regulations and standards. Drive product safety, product quality, and customer satisfaction related decisions, with appropriate authority (both data-based and risk-assessment-based decisions). Establish short- and long-term goals to improve complaint resolution, product reliability, and customer satisfaction. On time reporting of medical device reports. Addressing FDA and other NCA concerns with product recalls to achieve the best outcome (regarding recall classification and where applicable, continued product availability). Training and development of group members to satisfactorily complete their job activities and career aspirations. Ensuring group members have product and regulatory knowledge to perform their jobs compliantly. Driving continuous improvement and excellence in results for Key Performance Indicators (KPIs). Foster a culture of continuous improvement, accountability, and customer focus. Developing and supporting digitalization strategies for CPQ IVDR Plans and Reports for associated product lines Cross functional collaboration This position may suit you best if you are familiar with what is below, and would like to do develop your career with Healthineers Demonstrated ability to lead and manage people. Direct experience in the in-vitro diagnostics industry. Strong communication (written, oral, and listening) and problem-solving skills. Strong knowledge in complaint handling, investigations, medical device reporting, field action and CAPA processes. Proven experience covering post market topics in front room external inspections (e.g., FDA, TUV, etc.). Ability to balance heavy workload, customer needs, patient/operator health/safety and regulatory compliance. Strong technical knowledge of supported product lines. Experience: Typically, 8+ years of successful experience in related field and successful demonstration of responsibilities as presented above. Detailed understanding of FDA 21 CFR 820, 21 CFR 803, 21 CFR 806, ISO 13485, MDSAP, and EU IVDR requirements. Experience in Quality Systems, MDRs and Field Action recommended. Advanced degree MAY be substituted for experience, where applicable. Willing to travel 20% Education: BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience. Who we are: We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways. How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual's potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world's most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably. To find out more about Siemens Healthineers businesses, please visit our company page here. The base pay range for this position is: $172,690 - $237,446 Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate. If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company's plan. Commissions are based on individual performance and/or company performance. The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan. life insurance, long-term and short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time. Equal Employment Opportunity Statement: Siemens Healthineers is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law. EEO is the Law: Applicants and employees are protected under Federal law from discrimination. To learn more, click here. Reasonable Accommodations: Siemens Healthineers is committed to equal employment opportunity. As part of this commitment, we will ensure that persons with disabilities are provided reasonable accommodations. If you require a reasonable accommodation in completing a job application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please fill out the accommodations form here. If you're unable to complete the form, you can reach out to our HR People Connect People Contact Center for support at *****************************************************. Please note HR People Connect People Contact Center will not have visibility of your application or interview status. California Privacy Notice: California residents have the right to receive additional notices about their personal information. To learn more, click here. Export Control: “A successful candidate must be able to work with controlled technology in accordance with US export control law.” “It is Siemens Healthineers' policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.” Data Privacy: We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. Register here to get started. Beware of Job Scams: Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as Siemens Healthineers recruiters/employees. These scammers may attempt to collect your confidential personal or financial information. If you are concerned that an offer of employment with Siemens Healthineers might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on the Siemens Healthineers career site. To all recruitment agencies: Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes.

Datavant is a data platform company and the world's leader in health data exchange. Our vision is that every healthcare decision is powered by the right data, at the right time, in the right format. Our platform is powered by the largest, most diverse health data network in the U.S., enabling data to be secure, accessible and usable to inform better health decisions. Datavant is trusted by the world's leading life sciences companies, government agencies, and those who deliver and pay for care. By joining Datavant today, you're stepping onto a high-performing, values-driven team. Together, we're rising to the challenge of tackling some of healthcare's most complex problems with technology-forward solutions. Datavanters bring a diversity of professional, educational and life experiences to realize our bold vision for healthcare. Datavant is seeking a strategic and hands-on Director of Quality to lead product and supplier quality assurance efforts within our Life Sciences business unit, which includes the Datavant Connect and Aetion Evidence Platform. These platforms deliver regulatory-grade real-world data (RWD) solutions through tokenization, data linkage, and privacy-preserving analytics. As Director of Quality, you will own the implementation and evolution of GxP-aligned quality practices that support regulated data services and software. This includes oversight of software validation, privacy compliance, supplier qualification, and audit readiness. You will also lead a team of quality specialists and partner cross-functionally with Product, Engineering, Security, Privacy, and Customer Assurance to ensure that we meet or exceed regulatory expectations and customer trust standards. This role is essential to operationalizing Datavant's Quality Management System (QMS) across internal and external stakeholders and enabling continued growth in regulated RWD and evidence generation environments. What You Will Do Lead the development and continuous improvement of Datavant's QMS across Life Sciences products and supplier relationships, ensuring GxP and privacy compliance. Manage and mentor a team of quality specialists responsible for core functions such as CAPA, internal audits, validation, and supplier monitoring. Serve as the primary quality liaison to product development teams (Connect and Aetion), providing guidance on SDLC quality controls, validation strategies (GAMP 5, Part 11), and regulatory risk mitigation. Oversee supplier qualification and re-evaluation processes, including risk-based assessments, audit coordination, and performance monitoring. Establish and maintain quality metrics (e.g., CAPA closure, audit readiness scores, supplier performance) and drive continuous improvement initiatives. Support readiness for and participation in customer audits and external assessments (e.g., pharma clients, CROs, regulatory partners). Partner with Security and Privacy teams to align product and supplier practices with frameworks like HIPAA, GDPR, and FedRAMP. Lead or support periodic management reviews of the QMS and contribute to strategic quality planning and resource allocation. Ensure clear documentation and traceability across all quality activities, systems, and changes in compliance with FDA 21 CFR Part 11 and ICH E6(R3). Represent Datavant's quality program in external communications, including client onboarding, RFIs, and quality-related escalations. What You Need to Succeed 8+ years of experience in quality, compliance, or regulatory roles within life sciences, digital health, or regulated software organizations. Strong working knowledge of relevant regulations and frameworks, including FDA 21 CFR Part 11, GAMP 5, ISO 9001, ICH E6(R3), HIPAA, and GDPR. Proven leadership in scaling and operationalizing a QMS in a SaaS, RWD, or GxP context. Experience managing and mentoring cross-functional teams. Demonstrated success overseeing validation, supplier oversight, internal audits, and CAPA management. Deep understanding of data governance, privacy, and security best practices. Experience interacting with external auditors, customer compliance teams, or regulatory agencies. Strong communication skills-capable of explaining complex quality topics to product, legal, technical, and customer-facing stakeholders. What Helps You Stand Out Prior experience supporting real-world data (RWD) platforms or evidence generation technologies used in regulatory submissions. Background working in or with tokenization, health data linkage, or privacy-enhancing technologies. Experience interfacing directly with pharmaceutical, biotech, or CRO quality teams. Training or certification in Six Sigma, ISO Auditing, or software validation methodologies. Familiarity with supplier portals, quality dashboards, or eQMS platforms (e.g., Veeva, MasterControl). Experience contributing to industry working groups on quality, data integrity, or health data compliance. #LI-BC1 We are committed to building a diverse team of Datavanters who are all responsible for stewarding a high-performance culture in which all Datavanters belong and thrive. We are proud to be an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. At Datavant our total rewards strategy powers a high-growth, high-performance, health technology company that rewards our employees for transforming health care through creating industry-defining data logistics products and services. The range posted is for a given job title, which can include multiple levels. Individual rates for the same job title may differ based on their level, responsibilities, skills, and experience for a specific job. This role is eligible for additional variable compensation. The estimated base salary range (not including variable pay) for this role is:$165,000-$230,000 USD To ensure the safety of patients and staff, many of our clients require post-offer health screenings and proof and/or completion of various vaccinations such as the flu shot, Tdap, COVID-19, etc. Any requests to be exempted from these requirements will be reviewed by Datavant Human Resources and determined on a case-by-case basis. Depending on the state in which you will be working, exemptions may be available on the basis of disability, medical contraindications to the vaccine or any of its components, pregnancy or pregnancy-related medical conditions, and/or religion. This job is not eligible for employment sponsorship. Datavant is committed to a work environment free from job discrimination. We are proud to be an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. To learn more about our commitment, please review our EEO Commitment Statement here. Know Your Rights, explore the resources available through the EEOC for more information regarding your legal rights and protections. In addition, Datavant does not and will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay. At the end of this application, you will find a set of voluntary demographic questions. If you choose to respond, your answers will be anonymous and will help us identify areas for improvement in our recruitment process. (We can only see aggregate responses, not individual ones. In fact, we aren't even able to see whether you've responded.) Responding is entirely optional and will not affect your application or hiring process in any way. Datavant is committed to working with and providing reasonable accommodations to individuals with physical and mental disabilities. If you need an accommodation while seeking employment, please request it here, by selecting the ‘Interview Accommodation Request' category. You will need your requisition ID when submitting your request, you can find instructions for locating it here. Requests for reasonable accommodations will be reviewed on a case-by-case basis. For more information about how we collect and use your data, please review our Privacy Policy.

Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed. The Opportunity Praxis is hiring a Clinical Quality leader who sees quality as a catalyst-not a checkpoint. In this role, you'll help define and drive a strong GCP quality culture across all clinical programs, balancing rigor with speed and foresight. You'll oversee clinical quality systems and metrics, anticipate and escalate risk before it becomes an issue, and work shoulder-to-shoulder with Clinical Operations, Regulatory, Safety, and other partners to keep our trials inspection-ready and continuously improving. At the same time, you'll support and develop Clinical Quality team members embedded in programs, guiding inspection readiness, deviations, investigations, audits, and CAPAs-while helping shape an integrated, proactive clinical quality strategy that scales with our pipeline. Primary Responsibilities Clinical Quality (GCP, GPvP, GCLP) Compliance Oversight Develop and report key quality metrics across all clinical programs and trials Assess current-state quality across programs, processes, and trials Identify trends, risks, and lead process and system improvements Ensure compliance with GCP, ICH-GCP, FDA, EMA, PMDA, and applicable regulations Collaboratively author standard operating procedures and related documents Monitor regulatory changes and assess impact to programs Provide guidance and mentorship to clinical quality staff assigned to clinical programs and supporting study teams Vendor Quality Oversight Partner with vendor management to update Quality Agreement templates Develop a program and processes for quality oversight and accountability of CROs and other vendors and develop and report quality metrics for CROs and critical clinical vendor Quality Events, Audits & Inspections Review and approve deviations, investigations, and CAPAs Lead or participate in audits and regulatory inspections Drive inspection readiness at local and global levels Qualifications and Key Success Factors Bachelor's degree in a scientific field required; advanced scientific degree a plus 10+ years industry experience directly managing GCP/GPvP QA activities, audits, inspections, CAPAs, and risk management for multinational clinical programs and trials Must have worked within Sponsor organization although can be in combination with academic and/or CRO experience In-depth knowledge of quality, compliance, risk management, clinical trial operations, ICH-GCP Guidelines and other applicable regulatory requirements Experience mentoring and directing members of quality and clinical operations teams Experience working in a team across multiple functional areas (e.g., CMC / GMP Quality, Data Management, Biostats, Safety, Clinical Supply) Intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit Ability to think critically in fast-paced projects with a keen sense of urgency and demonstrated ability to create solutions and enable decisions Self-motivated and able to work autonomously, as well as a member of a high-functioning and collaborative team The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement. You'll need comfort with screen work, basic hand coordination, and focus. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions. Compensation & Benefits At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive. This includes 99% of the premium paid for medical, dental and vision plans. We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future? We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP. We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns. Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring. We aim high, collaborate hard, and produce results. Let's achieve the impossible together! To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below. Final salary range may be modified commensurate with job level, education, and experience. Annualized Base Salary$190,000-$220,000 USD Company Overview Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members. Diversity, Equity & Inclusion Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws. Attention: Job Scam Alert Praxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to ***************************. Praxis does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.

SummaryManaging, ensuring and improving capabilities to comply with external standards and regulations. Interprets internal and external business challenges and recommends best practices to improve products, processes or services. Stays informed of industry trends that may influence work. GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.Job Description Roles and Responsibilities Own the Pharmacovigilance (PV) Audit Program: Develop, implement, and maintain the global PV audit strategy, ensuring alignment with regulatory expectations (e.g., EMA, FDA, MHRA, PMDA) and industry best practices. Manage Audit Operations: Oversee scheduling, planning, execution, reporting, and follow-up for PV audits, including internal audits and audits of service providers and affiliates. Fully participate in the audit program; actively owning and executing PV audits. Risk Identification and Communication: Identify high-risk compliance issues, escalate findings, and provide actionable recommendations to senior leadership. Regulatory Inspection Support: Prepare for and support PV-related health authority inspections, including back-room management and post-inspection follow-up. Metrics and Reporting: Define and track PV audit KPIs, ensuring visibility of compliance risks and trends to leadership. System Ownership: Manage audit-related modules within the electronic Quality Management System (eQMS), including support of configuration, UAT, and documentation. Team Leadership: Lead and develop a team of 3-5 auditors, providing coaching, mentorship, and performance management. Cross-Functional Collaboration: Partner with PV Operations, Quality, and Regulatory teams to ensure audit outcomes drive continuous improvement. Strategic Influence: Contribute to policy development and influence PV compliance strategy across the organization. Required Qualifications Minimum 5 years of people leadership experience, including team development and performance management. Qualified Lead Auditor with active certification. Master's degree and 5+ years in pharmacovigilance or pharmaceutical industry; or Bachelor's degree and 10+ years relevant experience. Minimum of 5 years' experience driving Global programs to resolve quality compliance issues (directly). Experience with Pharmaceutical QMS requirements and regulatory requirements including but not limited to cGMP, GDP, GPvP, GCP and GLP. Experience with Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485. Desired Characteristics Prior Veeva and TrackWise Digital experience a plus. Prior health authority experience a plus. IRCA, ASQ (CQE, CQA, etc.) and/or Lean Certification a plus (green belt, black belt). Extensive experience in the Medica Device and Pharmaceutical industry. Understanding of product quality improvement using tools such as Six Sigma, DFR. Demonstrated ability to analyze and resolve problems. Exceptional conflict-resolution skills. Ability to interface with top organizational leadership and internal and external customers, responding in a professional manner. Demonstrated ability to lead programs / projects. Ability to prioritize and drive multiple programs. Ability to energize others by building a connection with the team through personal involvement and trust, providing feedback and coaching to develop others, and accountability of actions. Strong oral and written communication skills in English. Integrity: Accepting and adhering to high ethical, moral, and personal values in decisions, communications, actions, and when dealing with others. Ability to travel globally up to 30%. We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership -always with unyielding integrity. Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support. We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $139,200.00-$208,800.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.Additional Information GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees. Relocation Assistance Provided: No Application Deadline: January 30, 2026

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. Overview: Candidates may need to travel to investigator sites Candidates can sit remote but need to be able to travel to Cambridge Local candidates preferred but they can work from home occasionally 1 year assignment to start. Not a perm assignment. Interim position. Person must be able to coordinate other QA contractors for audits Must also be able to deliver SOP's and processes and This is ONLY in the GCP area Must have GCP experience Must have Pharma Experience within Quality Assurance Coordinating audits (internal, external) Inspection experience (FDA) Need to have worked in a development program so they know how to coordinate audits for a development program Job Description: Job Title: Director, Vaccines Clinical Compound Support Quality Assurance OBJECTIVES: • Plays a leadership role in ensuring that investigator, vendor, facility and system audits are conducted, for communicating any critical compliance risks noted from these activities to senior management, and ensuring that corrective actions are implemented. • Serves as a senior strategic GCP/PV quality resource to VBU for its vaccine development activities, and takes a lead role for the preparation, conduct, and responses to FDA audits of VBU's Clinical Research effort. • This position provides leadership and strategy in line with global strategic objectives. Collaborates with all VBD functional areas to ensure all assigned global clinical trial activities sponsored by VBU are in compliance with Good Clinical Practice (GCP) regulations, the International Conference on Harmonization (ICH) and Policies and Procedures. ACCOUNTABILITIES: • Ensures the development and implementation of strategies regarding the processes, procedures and quality standards required to maintain compliance to applicable regulations. • Responsible to develop and implement a strategic audit plan for a VBU vaccines development program. • Analyze audit program results, quality issues and investigations in order to optimize regional operations and overall regional state of compliance.Ensure that activities are conducted and reports written according to applicable SOPs and regulations. • Represents VBU and serves as Inspection Administrator during regulatory inspections. Provides strategic organizational direction to assure that responses are timely and appropriate to maintain VBU's (US) good standing with regulatory agencies. • Oversees all GCP QA, PVQA, and GCLP QA activities (including internal or external audit observations and development of adverse trends) in US and LATAM in order to ensure patient safety and data integrity. • Identifies and mitigates GCP/PV/GCLP quality and compliance issues with potential impact across multiple compounds, sites, or functional groups within or outside of VBU . • Collaborates with the R&D QA, and other global entities to provide a consistent quality approach, including: o Develops and presents periodic reports for assigned project describing VBU compliance trends and identifying areas of potential risk to VBU senior management. • Determines acceptability of vendors for potential use by VBD and provides direction, guidance and strategy for VBU Quality. EXPERIENCE, KNOWLEDGE AND SKILLS: Knowledge and Skills: In-depth knowledge of the applicable GXP regulations, FDA Good Clinical Practices, ICH Guidelines, FDA Regulations and Guidances and Computer System Validation • Auditing Knowledge: Demonstrates advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data integrity. • Clinical Development: Understands the phases, processes and techniques used to execute a clinical development program. • Product Knowledge: Understands the medical impact of vaccines. • Science Knowledge: Possess the necessary science education and knowledge to manage related clinical trials and to assure ethical treatment of subjects. Understands medical terminology and is familiar with standards of care and disease states. • Communication skills: Must professionally, clearly, concisely and consistently communicate to external and internal customers via phone, e-mail, fax, and written documents. Must also be able to demonstrate professional presentation skills deliver fair balanced presentations and, when applicable, facilitate resolution of differing opinions. • Negotiation Skills: Demonstrates proficiency in negotiation and conflict resolution. • Project Management: Must demonstrate proficiency in managing complex projects, delivering all expected deliverables in a timely manner, and proactively communicating changes in pre-established goals and deadlines. • Organizational skills: Must be able to prioritize work effectively to meet timelines. • Interpersonal: Must be able to adapt to other personalities in a respectful manner that is conducive to goal achievement and team building. • Computer skills: Must be able to efficiently utilize the computer hardware and software programs provided to plan, manage, conduct and track deliverables and to communicate with internal and external team members. LICENSES/CERTIFICATIONS: • ASQ Certified Quality Auditor (CQA), ASQ Certified Manager of Quality/Organizational Excellence, or SQA Registered Quality Assurance Professional preferred. TRAVEL REQUIREMENTS: • Ability to drive to or fly to various meetings or client sites, including overnight trips. Some international travel may be required. • Requires approximately 20 % travel. Qualifications Education: • B.S. in Biology, Nursing, Pharmacy, or related scientific field. MS preferred. Experience: • Minimum of 10 years of increasing responsibility in pharmaceutical, GCP-related Quality environment. • Minimum 7 years indirect management level experience in GCP Quality Assurance including senior level project planning/budget management. Additional Information Kind Regards, Sabanaaz Shaikh Clinical Recruiter Integrated Resources, Inc. IT Life Sciences Allied Healthcare CRO Gold Seal JCAHO Certified ™ for Health Care Staffing “INC 5 0 0 0 's FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)

We are seeking a Director, Quality of Earnings (QoE) to join our Strategic Financial Planning and Analysis (Strategic FP&A) practice. This individual will report to the Strategic FP&A Practice Leader and support the growth delivery of QoE engagements, providing deep analytical and technical accounting insight to evaluate business performance and sustainability. The ideal candidate has diverse experience as an accomplished accounting and financial professional, with a strong foundation in executing QoE analysis and possesses broad expertise and understanding of FP&A, technical and operational accounting, and data reconciliation. This position offers the opportunity to help shape Acclarity's QoE service offering, develop firmwide tools and templates, and contribute to internal training initiatives. You will work closely with Market Leaders and Client Service Leaders on private equity (PE) clients and their portfolio companies to deliver high-quality analyses that inform strategic transactions, while also identifying opportunities for cross-functional engagement across Strategic FP&A and other Acclarity Practices ‘service offerings. Essential Duties & Responsibilities Lead the execution of QoE analyses, including the review of revenue streams, working capital, expense structures, and other key business drivers. Conduct financial statement analysis and assess the sustainability of earnings by distinguishing recurring from nonrecurring items. Develop and maintain QoE work programs, templates, and standardized reporting packages for consistent service delivery. Partner with leadership to refine and scale the QoE methodology, ensuring alignment with client needs and industry best practices. Support the expansion of FP&A capabilities, including budgeting, forecasting, financial modeling, and business performance analytics. Collaborate cross-functionally to identify pull-through opportunities across G&OA and transaction-related engagements. Serve as a trusted advisor to clients, offering strategic recommendations grounded in strong technical accounting and business acumen. Contribute to internal training and development programs, including the design and delivery of “QoE Bootcamp” sessions across Acclarity practitioners. Participate in business development activities, including proposal creation, pipeline discussions, and client relationship management. Stay current with evolving technical accounting standards and industry trends affecting due diligence and financial analysis. Required Skills / Experience Bachelor's degree in Accounting, Finance, or related field; CPA or CFA strongly preferred. 6-10 years of total experience, with at least 4 years in Quality of Earnings or Transaction Advisory Services. Background in public accounting or experience with a Top 40 CPA firm strongly preferred. Ability to connect the dots and think strategically, with a deep understanding of financial statement analysis, working capital, and revenue recognition. Strong knowledge of GAAP, financial reporting, and internal controls. Advanced proficiency in Excel and financial modeling. Experience navigating within ERP systems (e.g., QuickBooks, Sage, Acumatica, NetSuite, Etc.) to extract important data for financial models Experience working with business intelligence (BI) and data analytical tools (e.g., Alteryx, Power BI, Qlik, Tableau) is a plus. Exceptional analytical and problem-solving skills with strong attention to detail. Excellent communication skills with the ability to explain complex issues clearly to executive and non-executive-level stakeholders. Proven ability to manage multiple engagements, prioritize deliverables, and meet tight deadlines. Comfortable with working as an individual contributor or in a team environment, partnering cross functionally with other practitioners in executing the client service delivery. Demonstrated leadership skills with a desire to mentor and develop talent. Strong technical accounting and financial analysis foundation paired with practical business acumen. Flexibility and desire to grow FP&A and operational advisory work outside of QoE. Adaptability and intellectual curiosity-someone who thrives in an entrepreneurial, evolving environment. The ability to bridge transactional and operational perspectives to deliver measurable client impact. About the Company Acclarity delivers transformation, transaction, and compliance consulting services to middle-market companies. Our team focuses on increasing the return on investment and mitigating risk. Our professionals are knowledgeable and skilled leaders who focus on a singular goal: to deliver measurable, lasting results that create value for you and your business. What differentiates us from our competitors is the combination of our technical knowledge, industry expertise, and prior leadership experience. Our professionals come from public accounting or large national consulting firms and have been business, finance, and technology leaders. This first-hand knowledge allows us to leverage our experience into practical, common-sense solutions for our clients. Our business is growing at a rapid rate. The ideal candidate will share the Acclarity passion for client service and delivering quality results. You must be hands-on and excited about working with integrated teams of accounting, finance, process, and IT professionals to find solutions for our clients. Acclarity is headquartered in Ft. Lauderdale, Florida. Competitive base salary, annual bonus, flexibility, and excellent full benefits package including Health, Dental, Vision, Life, Disability, 401(k), and more. ALL INQUIRIES ARE KEPT CONFIDENTIAL. Equal Opportunity Employer.

Careers with real impact. Every role at Orsini moves a patient closer to life-changing therapy. We partner with biopharma innovators, healthcare providers, and payers to make access simple, compassionate, and reliable - so no patient is left behind. Make your next role matter. ABOUT ORSINI Providing compassionate care since 1987, Orsini is a leader in rare disease and gene therapy pharmacy solutions, built to simplify how patients connect to advanced medicines. Through our comprehensive commercialization solutions including a nationwide specialty pharmacy, patient services hub, home infusion and nursing network, and third-party logistics provider, we work with biopharma, providers, and payors to ensure No Patient is Left Behind™ OUR MISSION Orsini is on a mission to be the essential partner for biopharma innovators, healthcare providers, and payers to support patients and their families in accessing revolutionary treatments for rare diseases. Through our integrated portfolio of services, we seek to pioneer comprehensive solutions that simplify how patients connect to advanced therapies while providing holistic, compassionate care so that No Patient is Left Behind™. CORE VALUES At the heart of our company culture, the Orsini LIVE IT Core Values serve as guiding principles that shape how we interact with each other and those we serve. These values are the driving force behind our commitment to excellence, collaboration, and genuine care in every aspect of our work. COMPENSATION & LOCATION The salary range for this role is $130,000-$140,000, compensation will be determined based on a combination of factors, including skills, experience, and qualifications. This remote position within the United States and may involve overnight travel for customer and internal meetings. POSITION SUMMARY The Director, Quality leads Orsini's enterprise Quality Management Program for rare disease specialty pharmacy operations. This role develops and executes the annual Quality Plan; ensures compliance with accreditation standards (URAC, ACHC, NABP) and applicable regulations (HIPAA, FDA, DEA, State BOP); oversees internal and external audits, vendor quality, deviation/CAPA management, document control; and partners cross-functionally to improve patient safety, clinical effectiveness, and operational excellence. The Director advances a culture of continuous improvement through data-driven insights, risk mitigation, and transparent reporting to senior leadership. ESSENTIAL JOB DUTIES: Quality System Leadership Own the Quality Management System (QMS), including policies, SOPs, work instructions, forms, and quality records. Ensure timely document lifecycle management (draft, review, approval, training, archival) and maintain accreditation readiness. Lead Quality Management Committee (QMC) governance and quarterly reporting. Accreditation & Regulatory Compliance Maintain full compliance with URAC, ACHC, and NAPB standards. Lead re-accreditation cycles, readiness assessments, gap remediation, and evidence documentation. Audit & Inspection Management Plan and execute internal audits and vendor audits; coordinate client audits and regulatory inspections. Track findings, risk-rank issues, manage corrective and preventitive actions (CAPA), and verify effectiveness. Report audit outcomes, trends, and closure timelines to senior leadership. Deviation, CAPA & Change Control Oversee deviation/incident management, root cause analysis, CAPA development, and change control. Analyze trends, implement preventitive measures, and communicate lessons learned across teams to reduce repeat events. Vendor Quality Oversight Oversight of the vendor qualification and monitoring program for specialty distribution, cold chain logistics, and service providers. Maintain quality agreements, scorecards, audits, and CAPA for vendors. Collaborate with Supply Chain to mitigate risk and improve performance. People Leadership & Development Manage and develop quality staff; set goals, coach performance, support career development, and foster engagement. Ensure staffing and succession planning for critical functions. Strategic Projects & Continuous Improvement Lead cross-functional initiatives to improve patient safety, data integrity, dispensing accuracy, cold-chain reliability, and patient experience. Utilize Lead/Six Sigma tools, statistical analysis, and dashboards to prioritize and track improvements. Collaboration & Key Stakeholders Works closely with Pharmacy Operations, Clinical Services (nursing, pharmacists), Patient Services, Compliance/Privacy, IT/Data & Analytics, Supply Chain/Logistics, Client Services, and Finance. Interfaces with accreditation bodies, auditors, payers, manufacturers (including REMS programs), and key vendor. Disclaimer: The information written in this indicates the general nature and level of work to be performed. This is not designed to contain or be interpreted as totally comprehensive of every job duty, responsibility, or qualification required by an employee assigned to this job. While employed in this position, an employee may be required to perform other assignments not listed in this job description. EXPERIENCE & EDUCATION 5+ years of quality assurance experience in specialty pharmacy or healthcare, with at least 3+ years in management capacity. Accreditation (URAC/ACHC) experience required; cold-chain and REMS program exposure preferred. Bachelor's degree in business, Healthcare, Pharmacy, or related, required; PharmD/advanced degree preferred. Certifications & Training (preferred): CQIA/CQA, Six Sigma/Lean, CPPS (patient safety) KNOWLEDGE Expert knowledge of quality systems, accreditation standards, and audit methodologies. Strong analytical skills: root cause analysis, risk assessment (FMEA), statistical trending. Outstanding written/verbal communication; executive reporting and presentations. Ability to lead cross-functional teams, influence without authority, and manage change. Proficiency with QMS platforms, document control, learning management systems (LMS), and dashboard tools. Demonstrated commitment to patient safety, data integrity, and continuous improvement. SKILLS Expert knowledge of quality systems, accreditation standards, and audit methodologies. Strong analytical skills: root cause analysis, risk assessment (FEMA), and statistical trending. Outstanding written/verbal communication; executive reporting and presentations. Ability to lead cross-functional teams, influence without authority, and manage change. Proficiency with QMS platforms, document control, learning management systems (LMS), and dashboard tools. Demonstrated commitment to patient safety, data integrity, and continuous improvement. EMPLOYEE BENEFITS We offer a comprehensive benefits package designed to support your health, financial security, and overall well-being: Medical Coverage, Dental, and Vision Coverage 401(k) with employer match Accident and Critical Illness coverage Company-paid life insurance options Generous PTO, paid holidays, and floating holidays Tuition reimbursement program. Equal Employment Opportunity Orsini Rare Disease Pharmacy Solutions is committed to the principle of Equal Employment Opportunity for all employees and applicants. It is our policy to ensure that both current and prospective employees are afforded equal employment opportunity without consideration of race, religious creed, color, national origin, nationality, ancestry, age, sex, marital status, sexual orientation, or present or past disability (unless the nature and extent of the disability precludes performance of the essential functions of the job with or without a reasonable accommodation) in accordance with local, state and federal laws. Americans with Disabilities Act Applicants as well as employees who are or become disabled must be able to perform the essential job functions either unaided or with reasonable accommodation. The organization shall determine reasonable accommodation on a case-by-case basis in accordance with applicable law.

There's never been a better time to join Stratus! As the market leader in brand implementation and maintenance, we transform how national brands connect with their customers. From exterior signage & interior branding to site refresh & remodel, from energy & lighting to repair & maintenance solutions, we deliver ideal solutions to meet all our client's branding needs. From our locations across the country, to our corporate headquarters in Mentor, Ohio, every employee is a stakeholder in Stratus' success. This environment offers endless career opportunities for individuals with a commitment to customer service, focus on execution and bias for action. Summary Stratus is seeking a strategic and enterprise-minded Director, Quality to lead all quality assurance and control initiatives for our brand implementation business, with a strong focus on exterior signage and interior branding and the manufacturing and installation for each service line. This role ensures that products meet the highest standards of craftsmanship, durability, and compliance while driving continuous improvement across design, fabrication, and field operations. The Director will champion a culture of quality excellence and customer satisfaction throughout the organization. Location Preference: We have a strong preference for candidates based in San Antonio, TX, Lexington, SC, Greater Chicago, or Greater Cleveland. However, we are open to highly qualified remote candidates who can commit to regular travel as needed. Responsibilities Quality Strategy & Leadership Develop and implement a comprehensive quality strategy aligned with business goals and client expectations. Lead and mentor the Quality team, fostering accountability and continuous improvement. Collaborate cross-functionally with Project Management, Engineering, Design, and Supply Chain teams to align quality objectives and support new product introductions and process changes. Manufacturing & Fabrication Quality Develop and implement quality standards across three internal plants and multiple external manufacturing partners to ensure compliance with company specifications and regulatory requirements. Monitor and audit production processes at internal and external facilities, identifying deviations and driving corrective actions to maintain consistent product quality. Ensure compliance with structural integrity standards. Process & Compliance Maintain and improve Quality Management Systems (QMS) in line with ISO standards and industry best practices. Ensure adherence to local building codes, electrical standards, and environmental regulations. Supplier & Vendor Quality In partnership with Field Partner Management (FPMG) and Supply Chain, establish and maintain supplier/vendor quality programs, including qualification, performance reviews, and continuous improvement initiatives for field partners and external manufacturing partners. Collaborate with procurement to ensure material consistency and reliability. Field Installation & Customer Experience Implement quality checks for installation teams to ensure flawless execution and brand consistency. Drive initiatives to reduce rework, improve timelines, and enhance client satisfaction. Continuous Improvement Utilize Lean, Six Sigma, or similar methodologies to optimize processes and reduce defects. Lead root cause analysis and corrective/preventive action processes for quality issues, ensuring timely resolution and documentation. Metrics & Reporting Define and monitor KPIs such as defect rates, on-time delivery, and customer satisfaction scores with action plans to strengthen underperforming areas. Provide regular quality performance reports to senior leadership. Qualifications Bachelor's degree in Engineering, Operations, Quality Management, or equivalent work experience preferred; Master's degree or MBA a plus. 10+ years of experience in quality management, with at least 5 years in a leadership role within a manufacturing environment. Strong knowledge of ISO standards, QMS, and regulatory compliance. Experience with Exterior Signage, Architectural elements, and Interior Branding projects preferred. Lean Six Sigma certification or equivalent strongly desired. Ability to manage quality across design, production, and installation phases. Travel This role will travel due to the need for in-person interaction with employees, customers, field partners, and/or business stakeholders. Travel may include local, regional, or national destinations and may be conducted via automobile, air, or other modes of transportation. All travel must be pre-approved in accordance with company policy and conducted in compliance with applicable safety and expense guidelines. Why Work With Us Supportive & Friendly Culture Manage national accounts for Fortune 500 companies Medical, Dental, Vision insurance coverage options Flexible Spending & Health Savings Accounts (HSA) with company contribution to HSA Company paid Life Insurance 401k with competitive Employer Contribution Company paid Short/Long Term Disability Insurance Generous Paid Time Off program + Holidays Career Growth Opportunities and Career Mapping Additional perks including Pet Insurance, Employee Assistance Program, Educational Assistance Program, Identity Theft Protection, Critical Illness Plans, Commuter Benefits and various employee discount offerings from our Vendors Pay Range $130,000- $155,000 annually - Pay range listed reflects the potential pay for this role. The pay will depend on various factors, such as responsibilities of the position, job duties/requirements, and relevant experience and skills. Not all positions posted will have a pay range listed. eeo/mfdv #LI-REMOTE

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. This is an exciting time to join Crinetics as we shape our organization into the world's premier fully-integrated endocrine company from discovery to patients. Join our team as we transform the lives of others. POSITION SUMMARY: The Director, Quality Assurance (GCP) oversees the development, implementation, maintenance, and performance of GCP Quality Assurance systems both within company and external vendors. The Director will execute and/or ensure proper oversight of the GCP QA audit program management, clinical operations phase 1 to phase 4 study team support, regulatory inspections, and GCP QA infrastructure development. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: These may include but are not limited to: General Provide GCP quality assurance strategy and oversight of QA GCP operations Ensures that clinical trials and research activities adhere to regulatory requirements, industry standards, and internal policies Develop and implement risk management strategies to identify, assess, and mitigate risks Drive effective initiatives that foster a culture of quality and continuous improvement Successfully collaborate on multiple projects with cross-functional stakeholders Lead investigations of significant complexity Prepare and present to executive management Manage, lead, and mentor quality assurance team members; lead cross-functional teams on compliance projects Audit Management Develop a plan with CROs for clinical sites' audit execution Manage clinical site, TMF, and GCP and GLP vendor audit activities Generate and/or review and approve overall GCP QA audit plans and schedules Generate and/or review and approve audit trend reports Execute the GCP QA audit program to ensure that processes and systems are adequate for communicating, addressing, and preventing identified GCP compliance issues and trends Study Team Support & Issue Escalation Management Represent QA at program-wide (e.g., study team or governance) meetings and provide GCP guidance and feedback Serve as point of escalation for GCP compliance issues identified by clinical study teams or QA leads, and responsible for informing the head of QA and Management, as required Manage quality events, CAPAs, and deviations Collaborate with cross-functional teams (Clinical Operations, Clinical Research, Regulatory, etc.) to embed quality by design in clinical programs. Provide guidance and support to Trial Master File activities Quality Systems / Inspections / Infrastructure Ensure adequate systems and controls are in place for GCP compliance Identify and address quality systems gaps, including internal processes and personnel GCP training Execute the review of GCP SOP tracking and status reports to ensure timely review and development of SOPs Author, review, or revise SOPs related to clinical and non-clinical studies Develop and provide GCP training Support regulatory inspection activities and GCP inspection readiness activities Prepare internal team, clinical sites, and vendors for inspection readiness Thoroughly review clinical study documents Perform breach assessments Oversee quality vendor management and governance for GCP and GLP vendors Review Quality Agreements to ensure clear delineation of responsibilities and compliance expectations between the sponsor and the vendor Contribute and present GCP quality events and metrics at the Quality Management Review meeting Support other Quality Assurance and Quality Systems activities Other duties as assigned. Education and Experience Required: Minimum Bachelor's degree in a science discipline and at least 12 years' experience in a QA function within the pharmaceutical/biotech industry (an equivalent combination of experience and education may be considered) Minimum of 8 years of working in a GCP QA function Previous experience leading inspection readiness and audits Thorough understanding of FDA, EU and local regulations, as well as understanding of ICH guidelines Hands-on experience in developing and implementing GCP procedures Strong working knowledge of GCP and GLP regulations Proven ability to cultivate and develop relationships with cross functional teams and vendors Demonstrated leadership ability to identify, manage and develop QA teams Must be able to make critical and strategic decisions based on risk-assessments Capable of managing multiple projects simultaneously Excellent communication and listening skills Preferred: Auditing certification is a plus Physical Demands and Work Environment: Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities. Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply. Travel: You may be required to travel for up to 10% of your time. The Anticipated Base Salary Range: $176,000 - $220,000 In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process. Equal Opportunity Employer: Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws. Vaccination requirement: Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, Crinetics requires that all employees and contractors be fully vaccinated and have received the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation. Salary Range The salary range for this position is: $180,000 - $225,000. In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.

Who we are We're a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world's most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs - in the best possible way. Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit. Why Worldwide We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us! What the Quality Assurance Department does at Worldwide The Quality Assurance department sets the bar high when it comes to quality. We are committed to exceeding the quality standards required by our sponsors, study participants, and regulatory authorities. Our QA culture is based on an environment where staff are trained, energized, and empowered to deliver high-quality products to our employees and customers. What you will do Responsible for a risk-based Quality Vendor Oversight Program to ensure quality of deliverables and compliance to GxP regulations. Establish GCP Vendor quality agreements and GMP quality technical agreements with key external customers. Establish QA to QA meetings for key vendors. Defining and monitoring quality tolerance limits for Vendors working in collaboration with the Vendor Management Team Oversee the management of the QVD Audit Plan inclusive of vendors, depots, CSV, vendor, system, GMP and GDP audits/CAPAs. Partner internally with key QA customers and operational internal stakeholders including to achieve Quality objectives. Serve as a GCP/GxP subject matter expert for GMP, GDP, and GCP related services as applicable to Vendors and Systems. Undertake GxP compliance oversight for new systems and operations championing a quality by design approach. Identify and drive continuous improvement in GxP compliance for Worldwide Vendor and system processes activities. Responsible for management and oversight of Vendor and system, quality issues, CAPA and Change control. Support Worldwide inspections and Sponsor Audits as necessary. Lead, mentor, and inspire a global team, fostering a collaborative and innovative environment. What you will bring to the role Demonstrated organizational leadership competencies. Ability to lead a team of individuals with a clear vision and defined purpose. Demonstrated ability for driving results and role modeling as a cross functional collaborator. Strategic thinker, hands on, highly organized, detail oriented. Demonstrated ability to effectively communicate, escalate, and influence the outcomes of decision-making process. Has an advanced understanding of clinical research principles and processes for clinical trials. Experience with identifying and implementing regulatory changes within life sciences organizations. Previous experience with leading / participating in Regulatory Authority Inspections e.g.: FDA BIMO inspections, MHRA GCP inspections, Health Canada GCP inspections, EMA GCP inspections, or other international Regulatory inspections. Your experience Bachelor's degree or 4 year degree equivalent required; MS in a scientific or allied health field preferred. Minimum of 12 years of relevant GxP experience. Minimum of 4 years of management experience. Experience of clinical, phase I and laboratory operations and systems. Experience in Quality CSV OR: Knowledge of Clinical System Validation. Advanced working knowledge of ICH Guidelines, FDA regulations, European Directives, UK Statutory Instruments. Broad expertise related to understanding the GxP global requirements - regulations, laws and guidelines with the ability to identify key requirements and changes as they relate to Worldwide. Understanding of 21 CFR Part 11 regulations and other international guidelines specifically addressing Computer Systems Electronic Record/Electronic Signature. Domestic and international travel required (approximately 10-15%). We love knowing that someone is going to have a better life because of the work we do. To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit ***************** or connect with us on LinkedIn. Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We're on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.

At Headlands Research, we are dedicated to enhancing clinical trial delivery within our communities. As a leading network of advanced clinical trial sites, we leverage cutting-edge technology and exceptional support services to broaden outreach and participation. Founded in 2018, our rapidly growing company currently operates 20+ sites across the US and Canada, with plans for further expansion. The Company At Headlands Research, we are building a best-in-class site network to improve the delivery of clinical trial options in the communities we serve. We're an exceptional family of next-generation clinical trial sites, integrating cutting edge technology and high-quality support services, and significantly expanding outreach and participation with a focus on participant diversity. Founded in 2018, our company is in high growth mode; we operate 21 clinical trial sites in the US and Canada and have rapid expansion plans. The Role The Director of Quality is tasked with ensuring that Headlands delivers consistent, high-quality data to our pharma partners as well as ensuring patient safety during the trial process. This individual will oversee quality and training functions for the organization including, but not limited to, the development and maintenance of quality assurance and training programs and policies, oversight of inspections and audits, quality diligence for acquired sites, and management of SOP's and quality documents to ensure GCP and all regulatory guidelines are adhered to. In addition to strategic oversight, the Director will also serve as the Quality Leader for a group of sites. This includes hands-on support in quality reviews, audit/inspection preparation, and CAPA resolution, ensuring that sites are inspection-ready and quality standards are consistently met. Direct Reports- 3-4 This individual should bring a strong background in the clinical trial industry with specific experience supporting and leading multi-site or large research organization quality development programs. Candidates should appreciate the atmosphere of a growing company and the need to impact process development while supporting sites. Success in this position requires agility, collaboration and exceptional critical thinking and problem-solving abilities. Duties Oversee and direct the Quality Department, ensuring its alignment with the broader business strategy and adherence to industry standards, while establishing clear goals and promoting a culture of quality, compliance, and ongoing improvement. Communicate, train, and author (when applicable) Standard Operating Procedures (SOPs) including periodic review/revisions of procedures and policies to ensure compliance with regulations and guidelines in both the US and Canada. Develop and maintain key performance indicators (KPIs) to evaluate the effectiveness of quality assurance activities and initiatives. Conduct and/or oversee annual and monthly quality reviews. Support the corporate development team through quality review of potential acquisition candidates. Developing and monitoring employee training as applicable to quality, including GCP, IATA, PHI, KnowB4, etc. Develop, implement, and maintain an internal review monitoring system and schedule. Report out on quality trends and metrics to aide in effective process improvement and risk management. Works with Regional Director of Operations, Quality Managers and Site Directors to ensure quality incidents are investigated, root cause analysis is performed, and a CAPA has been implemented and monitored for effectiveness. Partners with regional leaders and site teams to identify potential changes and opportunities for process improvement. Provide guidance, support, training and interpretation of regulations, guidelines, and policies Supports coordination of sponsor audits, regulatory inspections, and mock audits. Oversee documentation, reporting and closure of significant compliance and/or site review findings. Acts as backup Quality Manager for all sites within the network. Serve as the Quality Leader for assigned sites, providing direct hands-on support with quality reviews, audits/inspections, and CAPA resolution to reinforce site-level compliance and readiness. Facilitates New Hire Orientation and on boarding in collaboration with HR for clinical operations to specific functions related to quality. Develops and implements a mentorship program for new site employees to foster quality across the enterprise. Facilitates CTMS training in collaboration with ESource team. Requirements: Education - bachelors-degree in business or a health-related field required; master's degree preferred 5 years' + experience in clinical trials industry (sponsor or site) with experience in managing quality 3+ years' experience leading a team Experience with Quality oversight in Canada preferred but not required Prior experience authoring site SOP's preferred but not required Fundamental knowledge of US regulatory standards and guidelines for the conduct of clinical trials (ICH GCP, FDA; EMA; ANZ regulations) Ability to work in a remote setting with travel required sometimes with short notice Demonstrates strong analytical and proactive problem-solving skills Strong written and verbal communication skills Exceptional organizational skills, ability to multi-task and be detail oriented Experience developing and implementing training materials Accomplishes work in accordance with scheduled objectives and effectively meets deadlines Ability to maintain high degree of professionalism and integrity

The American Diabetes Association (ADA) seeks a Director, Primary Care and Quality Improvement to support the execution and advancement of ADA's Primary Care and Quality program portfolio. This role will contribute to the development, implementation, and dissemination of evidence-based practices aimed at improving care for individuals living with diabetes and/or obesity. The position will specifically focus on supporting primary care practices implement best practices as they relate to diabetes technology. The Director will apply dissemination and implementation science (D&I) principles along with quality improvement science (QI) methodology to optimize program outcomes. They will manage assigned primary care quality initiatives and ensure alignment with ADA's strategic goals. RESPONSIBILITIES Collaborate with the Senior Director in the development, implementation, and dissemination of assigned programs. Manage high-quality, end-to-end quality initiatives to meet the organization's needs, including partner engagement, program implementation, and dissemination strategies. Oversee the project life cycle of quality improvement initiatives with quick turnaround times so that key performance indicators are met successfully on time. Provide expertise in QI and/or D&I science methodology and practice facilitation to optimize program outcomes. Collaborate with other ADA team members and divisions/departments, as requested. Support data collection, management, and integrity with contracted organizations. Support maintenance of records and details of policies and procedures for program application and review to ensure programmatic continuity. Develop and deliver presentations and program reporting to funding organizations. Monitor quality program expenses and budgets. Oversee development and maintenance of program content and review and approval of grant related content used in dissemination. Engage in grant writing as needed to further support the efforts of the department and the ADA. Manage vendor relationships as appropriate. Other duties as assigned. QUALIFICATIONS Bachelor's degree required, Healthcare Administration or Public Health focus preferred 5+ years in QI or Implementation Science in primary care settings Experience working with diabetes technology (CGM, AIDs) strongly preferred Experience in practice-based research, primary care quality improvement, and practice facilitation is preferred Diabetes knowledge and experience are preferred Ability to optimize and implement process improvements across the grant lifecycle Experience implementing project management processes, procedures, and policies Ability to prioritize, multi-task, and work independently to manage multiple concurrent activities and complex grant portfolios Strong attention to detail, and proven ability to effectively manage large amounts of data and communications in an organized, timely and accurate manner Ability to gain and maintain strong understanding of programs and to effectively communicate and explain them to constituents in both verbal and written form Proficient in the use of the Microsoft Office Suite (Word, Excel, Teams, Outlook) Excellent interpersonal and verbal communication skills, the ability to interact credibly across multiple departments and divisions within the Association and externally, with professional volunteers, donors, sponsors, and constituents within the community WHY WORK HERE The American Diabetes Association (ADA) offers a rewarding career working for one of the premier voluntary health organizations in the world supporting people with type 1, type 2 and gestational diabetes. Our employees like working at the ADA because of our mission, the inclusive environment, work-life balance, our benefits and our culture: Industry competitive base pay ranging from $80,000 - $88,000 for this role. Base offers are determined by several factors including but not limited to your relevant work experience, education, certifications, location, internal pay equity, etc. A culture of recognition including new hire welcome announcements, service anniversary awards, referral bonuses, monthly All Employee Assembly, appreciation awards Generous Paid Time Off, including holidays, vacation days, personal days and sick days Comprehensive benefits package including medical, dental, vision, Flexible Spending Accounts (FSA), disability & life insurance, pet insurance and retirement savings Guided by our mission, we provide top tier diabetes supply coverage through our medical benefits program A company focus on offering mental health programs and work/life balance with most of our employees working remote Joining our dedicated team affords the gratification of knowing beyond a doubt that you will impact the lives and well-being of millions

LOCATION: Remote - preference for incumbents that live in North Carolina or within 40 miles of the NC border. This position requires travel as needed. GENERAL STATEMENT OF JOB Under the supervision of the Customer Service Quality Manager, the Quality Management Specialist resolves member and provider grievances/complaints, processes incident reports, conducts Unlicensed Alternative Living Site Reviews, assists with Home and Community Based Service (HCBS) Assessments, assists with NC Treatment Outcomes and Program Performance System (NC TOPPS) Surveys, completes any needed health/safety site visits and completes provider investigations as requested for Quality Management. The position is responsible for resolving grievances and complaints received by Vaya Health by or on behalf of any member/recipient who is dissatisfied with a Vaya contracted provider, a Vaya employee, or any aspect of Vaya or it's service delivery system. This is accomplished by processing complaint and grievance reports, coordinating resources, and communicating with all relevant parties throughout the grievance/complaint resolution process in a manner that is timely, thorough, fair, impartial, consistent, and compliant with applicable laws, rules and regulations. The position is responsible for ensuring all regulatory and accrediting guidelines/requirements are upheld throughout the resolution process. The position is responsible for reviewing incidents submitted into the Incident Response Improvement System (IRIS), Back-up staffing reports, and QM-11 reports submitted by providers in Vaya's network. The position provides technical assistance and support to ensure all reporting requirements are met related to incidents and may include document preparation, records requests and meeting facilitation. In addition, the position monitors Provider sites within the Vaya Health provider network receiving reimbursement for service provision under Medicaid, the Innovations waiver, and state funding. The position monitors the remediation of areas of non-compliance to ensure adherence to all applicable rules, regulations, and best practice models and to ensure the health and safety of persons receiving services. This position will also provide back up oversight and suport to NC TOPPS and HCBS activities when the designated primary staff person is out on leave. The position will also complete any investigations or health/safety reviews as assigned. The individual must be knowledgeable about Vaya's internal processes as well as providers, services, and stakeholders throughout the public behavioral health and intellectual/ developmental disabilities (IDD) system. ESSENTIAL JOB FUNCTIONS Grievance, Complaint, Incident, Health & Safety Response and Reviews: This position will support Provider Quality Operations and Customer Service Quality. Support of these operations may be accomplished through various activities like those listed below, and although day to day work may include activities related to these items this is not a limited list. At the manager's and director's discretion activities may be divided among the incumbents which may lead to some incumbents completing some of these tasks more than others, but all incumbents must be cross trained and able to complete all items. Activities may include, but are not limited to: Member/Recipient/Provider Grievance/Complaint Resolution The incumbent is responsible for managing assigned complaints and grievances by ensuring the concern of the individual is properly acknowledged, documented, and addressed to work toward informal resolution by: Answering questions from members, recipients, stakeholders, or others about the complaint/grievance process Timely resolving complaints and grievances through the following activities: Phone interviews with the filer and person(s) who have a legitimate role in the issue to be resolved (i.e. staff, legal guardians, providers, care managers, etc.). to obtain additional information or clarification; Consultation with Vaya staff, licensed clinicians, and subject matter experts Provider record/information request and record review Maintain timely responses to inquiries regarding grievances and complaints Provide recommendations and direction to both service providers and members in an attempt to eliminate repeated grievances of a similar nature Provide feedback to providers regarding written responses to grievances and complaints Recognize grievances and complaints that include health and safety issues that need to be immediately addressed by accurately depicting the situation in a case staffing to the CMO Recognize health and safety issues may require investigation including; but not limited to, an on-site review to ensure any Vaya members in service locations are safe. Incident Report Review, Tracking and Technical Assistance The incumbent reviews incident reports from all Vaya provider agencies within the catchment area and incident reports from provider agencies that have Vaya enrollees who receive services outside Vaya's catchment area. IRIS is a mandated electronic system for provider and LME/MCO to document the occurrence of Level II and III incidents. Incident review and response includes the following: Ensure the incident report is complete and has accurate information, request any additional or missing information Evaluate the cause/prevention section and provide technical assistance to the provider when standards for future prevention are not met Evaluate the likeliness that the incident will be in the media and alert the CMO Tracking and trending of incidents; report any trends of concern to CIRC. In addition, this position is also responsible for completing the following incident report related activities: Track and trend back-up staffing reports and compile and prepare data for quarterly reporting as needed Track and trend QM-11 (level 1 incident) reports Health/Safety Reviews including any Site Review Monitoring activities for AFL Site Reviews Use a standardized tool (checklist) for initial AFL site reviews and annually thereafter Ensure the site has met HCBS standards and approval Medication review Review the site for Health and Safety concerns that are specific to the member/recipient Inform/educate the Provider about Vaya procedures for monitoring of existing and new AFL homes Completion and delivery of all written findings to the Provider, and follow up on all deficiencies Assess sites for health/safety when required from grievances/complaints as part of investigations Investigations: Assisting with On site investigations completed by any Quality Management Team Complete assigned investigations related to grievances/complaints or health/safety requests Complete Report of Findings Complete Plans of Correction for Out of Compliance noted in Report of Findings Communicate with Providers related to investigation and outcomes Communicate with grievant/complainant/stakeholders as required for investigations Additional Tasks: Provide Backup to HCBS Provider Self-Assessment Review and Approval Process including: Upon submission, process and ensure Provider Self-Assessments are complete, accurate and meet criteria for HCBS standards, provide information and technical assistance to providers in response to incorrect or missing information. Provide Back up to NC TOPPS Activities to comply with state requirements including: Respond to NC TOPPS email inquiries, answer questions from providers or provider staff about NC TOPPS requirements, provide technical assistance to providers or provider staff on NC TOPPS. KNOWLEDGE OF JOB Ability to develop practical, thorough, and creative solutions to complex problems Ability to conduct data analysis and recognize trends is essential Ability to effectively communicate trends within Vaya to address potentially serious issues is required Ability to actively listen to grievances and complaints while maintaining a positive outlook and attitude with members, co-workers, and stakeholders Ability to work remotely (from home) with little supervision and function as a self-starter Flexible worker who readily accepts assigned tasks, manages unfamiliar situations, and searches for every opportunity to help the team Excellent time management skills, including the ability to manage competing priorities and to complete tasks in a timely and accurate manner Highly productive and motivated individual who takes pride in a job well done, demonstrates initiative and is committed to self-accountability Strong attention to detail and extreme precision and accuracy Ability to work collaboratively with individuals at all levels and with varying backgrounds both within and outside of Vaya and build strong working relationships Strong organizational skills with the ability to multi-task Ability to manage constant transformation and adapt to changing mandates from regulatory authorities as well as Vaya executive leadership Ability to maintain the confidentiality of sensitive information in accordance with applicable laws, policies, rules and regulations Ability to problem-solve and provide practical, thorough, and creative solutions to work tasks Ability to learn, interpret independently, and apply a variety of complex policies and procedures Good working knowledge and proficiency in Adobe and Microsoft Office 365 products (Word, Excel, Outlook, PowerPoint, Teams, Visio, SharePoint, etc.) Familiarity with Navex software products (PolicyTech, EthicsPoint) a plus Thorough knowledge of how to use standard office equipment, including printers, scanners, and fax machines Knowledge of North Carolina's public behavioral health and I/DD system, including Vaya providers, services, and stakeholders, preferred Ability to work independently is essential Ability to research multiple Electronic Records Systems -Ability to understand claims data Ability to understand both physical and behavioral health diagnoses Ability to synthesize information gathered in the grievance process to write a succinct resolution letter Ability to interact with team while performing grievance resolution lead duties in a respectful manner Ability to use critical thinking skills, work independently with little or no direction, demonstrate initiative, and function as a self-starter Ability to develop practical, thorough, and creative solutions to complex problems EDUCATION & EXPERIENCE REQUIREMENTS High school diploma or GED required. Bachelor's degree in a Human Services field preferred. Must have A minimum of two years of experience in quality management, data collection and analysis is required, preferably within a behavioral health organization OR a minimum of two years of experience providing care and/or customer service in an acute care, physical health, physician and/or hospital setting. The Tailored Plan does not require NC Residency for this role; however, it is the preference of Vaya and the Quality Management department that incumbents of this role fall within the guidelines of NC Residency Requirement per the Tailored Plan and reside in North Carolina or resides within 40 miles of the North Carolina border. Preferred work experience: Meeting the requirements of being a Qualified Professional per 10A NCAC 27G .0104 preferred. Preferred licensure/certification: National Certified Investigator & Inspector Training and Certification is preferred. PHYSICAL REQUIREMENTS Close visual acuity to perform activities such as preparation and analysis of documents; viewing a computer terminal; and extensive reading. Physical activity in this position includes crouching, reaching, walking, talking, hearing and repetitive motion of hands, wrists and fingers. Sedentary work with lifting requirements up to 10 pounds, sitting for extended periods of time. Mental concentration is required in all aspects of work. RESIDENCY REQUIREMENT: Prefer incumbent reside in North Carolina or within 40 miles of the North Carolina border. SALARY: Depending on qualifications & experience of candidate. This position is non-exempt and is eligible for overtime compensation. DEADLINE FOR APPLICATION: Open until filled APPLY: Vaya Health accepts online applications in our Career Center, please visit ****************************************** Vaya Health is an equal opportunity employer.

Are you passionate about improving the quality of healthcare? Are you ready to leverage your talents to make healthcare better for everyone? Do you want the opportunity to give back to your community? Do you want to have fun at work ? Then join the growing team at Health Services Advisory Group (HSAG) that is transforming the delivery of healthcare in the United States! SummaryUnder supervision of the Director, the Quality Improvement Specialist (QIS) supports the Centers for Medicare & Medicaid Services (CMS) Quality Innovation Network-Quality Improvement Organization (QIN-QIO) Program by providing hands-on technical assistance and quality improvement (QI) support to healthcare providers-primarily nursing homes, hospitals, and physician practices. The QIS collaborates with providers to assess performance, conduct root cause analyses, and co-develop Quality Action Plans (QAPs) aligned with CMS priorities. This position plays a vital role in driving the adoption of evidence-based interventions, guiding providers through regulatory requirements, and helping them improve safety, care quality, and outcomes for Medicare beneficiaries through onsite visits, virtual coaching, and educational outreach. Core Competencies and Responsibilities- Provider Engagement and Relationship Management· Serve as the primary contact for assigned providers to promote participation and secure Provider Service Agreements.· Build and sustain collaborative relationships with providers and stakeholders to foster long-term engagement.· Clearly communicate complex healthcare and QI concepts via meetings, teleconferences, and written correspondence.· Refer inquiries appropriately and consult with supervisors and internal teams, when needed. QI and Technical Assistance· Apply evidence-based QI methodologies to conduct comprehensive assessments, perform root cause analyses, and deliver technical assistance aligned with CMS project goals and metrics.· Develop customized Quality Action Plans (QAPs) grounded in evidence-based interventions and recognized best practices.· Collaborate with internal teams and external stakeholders to implement effective QI interventions.· Deliver QI education, resources, and training to healthcare providers and stakeholders. Data and Reporting· Analyze clinical and operational data to identify performance gaps, interpret trends, and guide providers in implementing targeted QI strategies.· Provide tailored technical assistance through data analysis, QI coaching, and coordination of relevant resources.· Promptly and accurately document project activities, site visits, provider communications, and outcomes using HSAG and CMS-approved systems. Professional Development and Compliance· Maintain up-to-date knowledge of QI methodologies, tools, and best practices through continuous professional development.· Stay current on best-practice guidelines and regulatory updates from CMS, the Centers for Disease Control and Prevention (CDC), Substance Abuse and Mental Health Services Administration (SAMHSA), and other regulatory agencies. Project Execution and Team Collaboration· Manage multiple initiatives, deadlines, and deliverables with strong organization and accountability.· Contribute to the development of tools, educational content, reports, and other deliverables in a team environment.· Effectively shift strategies and support approaches to align with evolving program goals, regulatory updates, and emerging challenges in the healthcare environment.· Occasionally work extended hours to meet project deadlines.Other Qualifications Working knowledge of Microsoft Office, SharePoint, or similar productivity and customer relationship management (CRM) systems is preferred. Strong written and verbal communication skills, including experience delivering presentations, conducting training, and engaging with providers via phone and email. Commitment to improving healthcare quality, safety, and outcomes for Medicare beneficiaries. Detail-oriented with strong initiative, sound judgment, and the ability to manage multiple priorities independently. Education and Experience Requirement Bachelor's degree required; Master's degree preferred. Minimum of 5 years of experience in a healthcare-related field, including QI experience. LPN or RN preferred. Work EnvironmentThe work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. DisclaimerThis is not necessarily an exhaustive list of all responsibilities, skills, duties, requirements, efforts or working conditions associated with the position. While this is intended to be an accurate reflection of the current position, management reserves the right to revise the position or to require that other or different tasks be performed when circumstances change (e.g., emergencies, changes in personnel, work load, rush jobs requiring non-regular work hours, or technological developments). HSAG is an EEO Employer of Veterans protected under Section 4212.If you have special needs and require assistance completing our employment application process, please feel free to contact us. EOE M/F/Veteran/Disability

We are a nationally recognized healthcare management organization with over 40 years of experience delivering innovative, high-quality clinical solutions. Our mission is to improve member health outcomes by identifying risk, promoting treatment compliance, and delivering personalized care. Position Summary The Director of Utilization Management & Case Management provides strategic and operational leadership for UM and LCM programs. This role is responsible for driving clinical excellence, regulatory compliance, process improvement, and team performance while partnering with senior leadership, clients, and sales to support continued growth. Key Responsibilities Lead and manage UM and LCM teams, fostering high performance and professional development Ensure compliance with URAC standards and applicable state regulations Drive process improvement, efficiency, and automation initiatives Serve as clinical and operational SME for business development and new product launches Collaborate cross-functionally with Sales, Client Services, Clinical, and IT teams Support client relationships, reporting reviews, and strategic planning Participate in sales presentations and client meetings as needed Qualifications Bachelor's degree in healthcare, business, or related field Clinical background with healthcare leadership experience Progressive management experience in healthcare operations Experience working with senior leadership and external clients Experience in utilization management and case management Experience with self-funded groups and InterQual criteria preferred Strong communication, analytical, and leadership skills Ability to travel as needed (approximately 10%) Compensation & Benefits Competitive salary based on experience Comprehensive benefits package including medical, dental, vision, 401(k), PTO, and more Join Our Team If you are a strategic, results-driven healthcare leader ready to make an impact, we invite you to apply.

The Manager, Coding Quality is responsible for providing oversight of teammates and vendor teams to ensure medical coding practices are compliant with regulatory standards. The scope of this job includes evaluating the department coding audit program and collaborating with operations and education teams to ensure quality, education, and productivity are achieved. We invite you to apply today and join us in shaping the future of healthcare! Key Responsibilities: Manage the quality program by understanding and applying COPs, coding guidelines, and all other appropriate CMS program guidelines as it relates to home health care and hospice into day-to-day activities and ensure these standards are followed by the team. Manage stateside workforce and workforce planning by monitoring daily production queue metrics to anticipate and address staffing challenges in real time. Evaluate identified education enhancement opportunities for medical coding professionals, review changes in the quality metrics, and assist in education development and execution as needed. In partnership with the coding operations team, plan and prioritize maintaining an adequate threshold of highly trained medical coders that ensure client satisfaction. Analyze and report key performance indicators data to relevant teammates on a regular basis, assess trends as needs to anticipate issues, and ideate solutions as data indicates. Perform other job duties as assigned. Required Qualifications: Bachelor's Degree or equivalent work experience At least 4-6 years of relevant work experience At least 0-1 years of relevant management work experience Coding Certified (HCS-D or BCHH-C) OASIS certification and/or experience in OASIS review Job Expectations: Willing to work additional or irregular hours as needed Must work in accordance with applicable security policies and procedures to safeguard company and client information Must be able to sit and view a computer screen for extended periods of time #LI-KL2 #LI-Remote WellSky is where independent thinking and collaboration come together to create an authentic culture. We thrive on innovation, inclusiveness, and cohesive perspectives. At WellSky you can make a difference. WellSky provides equal employment opportunities to all people without regard to race, color, national origin, ancestry, citizenship, age, religion, gender, sex, sexual orientation, gender identity, gender expression, marital status, pregnancy, physical or mental disability, protected medical condition, genetic information, military service, veteran status, or any other status or characteristic protected by law. WellSky is proud to be a drug-free workplace. Applicants for U.S.-based positions with WellSky must be legally authorized to work in the United States. Verification of employment eligibility will be required at the time of hire. Certain client-facing positions may be required to comply with applicable requirements, such as immunizations and occupational health mandates. Here are some of the exciting benefits full-time teammates are eligible to receive at WellSky: Excellent medical, dental, and vision benefits Mental health benefits through TelaDoc Prescription drug coverage Generous paid time off, plus 13 paid holidays Paid parental leave 100% vested 401(K) retirement plans Educational assistance up to $2500 per year

About Us: Our purpose is to help clients exceed their financial health goals. Across the reimbursement cycle, our scalable solutions and clinical expertise help solve programmatic needs. Enabling our teams with leading technology allows analytics to guide our solutions and keeps us accountable achieving goals. We build long-term careers by investing in YOU. We seek to create an environment that cultivates your professional development and personal growth, as we believe your success is our success. JOB SUMMARY: About this position: Title: Coordinator, Utilization Management Location: Remote within US ONLY (equipment provided, work must be done within the US only) Required Schedule: Full-time shifts from 8:00 AM to 5:00 PM EST (Sunday - Thursday or Tuesday - Saturday) some holiday coverage required. Hourly Salary: $19.00 - $20.00 ESSENTIAL DUTIES AND RESPONSIBILITIES: Note: The essential duties and responsibilities below are intended to describe the general duties and responsibilities of this position and are not intended to be an exhaustive statement of duties. This position may perform all or most of the primary duties listed below. Specific tasks, responsibilities or competencies may be documented in the Team Member's performance objectives as outlined by the Team Member's immediate Leadership Team Member. About this position: Title: Coordinator, Utilization Management Location: Remote within US ONLY (equipment provided, work must be done within the US only) Required Schedule: Full-time shifts from 8:00 AM to 5:00 PM EST (Sunday - Thursday or Tuesday - Saturday) we cannot guarantee preferred shift and some holiday coverage required. Hourly Salary: $19.00 - $20.00 Responsibilities: Manage the Authorization process end to end, from initial notification, entry and submission of required information, follow up all the way to determination and discharge. Maintain detailed documentation of the record in the EMR system, in the internal CorroHealth system and in the Health Payer portals. Verify correct eligibility and benefits for patients. Act as a liaison between the hospital staff and the Health Payer to facilitate information sharing and successful process completion within allocated timeframe. Review timely filing guidelines regarding the utilization management process. Track and follow up with payers on pending authorizations to ensure timely responses. Contact payer to elicit further information regarding status, decisions and remove hurdles in the processing. Identify and escalate issues that may result in delays or denials. Manage assigned workload of accounts through timely follow up and accurate record keeping. Maintain compliance with HIPAA and other healthcare regulations. Minimum Qualifications: High School Diploma or equivalent. Associate degree in healthcare administration or equivalent preferred. 2 years of experience in hospital related billing/follow-up/healthcare setting/authorization field. Knowledge of/experience working with managed care contracts Experience working with customer support/client issue resolution management. Strong understanding of medical terminology and insurance processes. Experience working in EMR systems, Epic preferred. Excellent communication and organization skills. Strong multi-tasking skills, working in a face paced environment. Proficiency with MS Office and web systems. What we offer: Hourly pay: $19.00 - $20.00 (firm) Remote within US ONLY Equipment provided Medical/Dental/Vision Insurance 401k matching (up to 2%) PTO: 80 hours accrued, annually 9 paid annual holidays Life Insurance Short/Long term disability options Tuition reimbursement Professional growth and more! PHYSICAL DEMANDS: Note: Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions as described. Regular eye-hand coordination and manual dexterity is required to operate office equipment. The ability to perform work at a computer terminal for 6-8 hours a day and function in an environment with constant interruptions is required. At times, Team Members are subject to sitting for prolonged periods. Infrequently, Team Member must be able to lift and move material weighing up to 20 lbs. Team Member may experience elevated levels of stress during periods of increased activity and with work entailing multiple deadlines. A is only intended as a guideline and is only part of the Team Member's function. The company has reviewed this job description to ensure that the essential functions and basic duties have been included. It is not intended to be construed as an exhaustive list of all functions, responsibilities, skills and abilities. Additional functions and requirements may be assigned by supervisors as deemed appropriate.