Director of quality jobs near me

About the Role Whisker Labs is seeking a Manager of Quality Assurance to join our fully remote development team. Our mobile apps, web portals, APIs, backend components, and AI models play a critical role detecting early warning signs of electrical fires in homes, preventing one of the deadliest types of fires. Our products are used by over 1 million customers to help detect and mitigate fire hazards in homes, quite literally saving lives. Whisker Labs is growing rapidly, and the team maintains a high-energy, fast moving, and creative culture. The candidate will work within software development scrum teams and the quality assurance team to improve our quality assurance processes and tooling, understand functional requirements, define test cases, implement automated test suites for UIs and APIs, and execute and document those test suites. You must have substantial experience as a quality assurance engineer, as a leader of quality assurance teams, and be able to implement automated test cases in one or more UI test automation frameworks and API test automation frameworks such as Postman, Playwright, Cypress, TestComplete, JMeter, or similar. Key Responsibilities Lead Quality Assurance team, improving and establishing quality assurance processes and tooling. Mentor and manage quality assurance team members. Perform regular performance reviews and 1 on 1s. Fulfill a functional lead role in quality assurance testing of complex web portals and APIs. Fulfill a functional lead role in quality assurance testing of complex web portals and APIs. Collaborate with scrum team and product to define and document test cases. Implement and execute automated test suites for web portals and APIs using frameworks and such as Cypress, Playwright, Postman, and others. Implement and automate test suites using languages such as JavaScript and .Net C#. Utilize Jira and participate in daily scrum team “standups” to communicate and manage testing stories and testing activities. Utilize test case documentation tools such as TestRail to document test suites as well as the results of running those test suites. Thorough functional and cross browser testing of web portals. Understanding of our wider software solution, collaborating with peers across teams. Establish and maintain a high level of productivity and agility within a scrum team of high skilled full stack developers and data scientists. Qualifications Minimum of 3 years experience as a leader of a quality assurance organization, with personnel management responsibility. Minimum of 7 years experience as a highly productive and hands on quality assurance tester. Strong proficiency in one or more UI test automation frameworks such as Cypress, Playwright, TestComplete, or others. Proficiency implementing automated test suites in JavaScript and/or .Net C#. Strong proficiency in one or more API test automation frameworks such as Postman, NUnit. Minimum 5 years of hands-on experience implementing automated test suites. Extensive experience defining, documenting, and executing manual test cases for web portals and APIs. Experience with cloud ecosystems such as AWS. Bachelor's degree in computer science or computer engineering, or equivalent professional experience. Extensive experience with Jira. Extensive experience working within an agile scrum team. Experience with Git or equivalent code management tool. Ability to work effectively and reliably in a fully remote, fast-paced environment. Independent, self-learner, excellent problem solver. Preferred Qualifications Experience integrating automated tests suites with GitHub and build pipelines. Experience with TestRail. Experience with mobile app testing. Why Join Us? By joining our team, you will have the opportunity to be a part of a groundbreaking technology that is creating a new category while helping to protect families, homes, and communities from the devastating impacts of electrical fires. We are a passionate team, dedicated to revolutionizing fire prevention to make the world a safer place. Our pace and growth trajectory offer exceptional opportunities for professional development, and we offer competitive compensation and comprehensive benefits. If you want to take ownership, shape strategy, and drive meaningful change, you'll love Whisker Labs. Whisker Labs is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Loyal is a clinical-stage veterinary medicine company developing drugs intended to extend the lifespan and healthspan of dogs. Our mission is to help dogs live longer, healthier lives. We've already achieved significant milestones on our path to earning FDA approval for the first lifespan extension drug for any species. We have three products in our pipeline and are on track for FDA conditional approval within the next year. Loyal is a well-funded startup in growth mode. Our team includes scientists, veterinarians, engineers, operators, and creatives. This role will play a key role in supporting our growth strategies. About the role We're seeking an experienced Vice President, Manufacturing to lead all aspects of drug product (DP) manufacturing and packaging operations for Loyal's small molecule, oral solid dosage (OSD) programs. This role is essential to ensuring late-stage manufacturing execution, product launch readiness, commercial manufacturing oversight, and long-term supply continuity. The VP of Manufacturing will guide internal and external teams through process validation, PPQ, commercial technology transfer, packaging validation, and the establishment of commercial manufacturing operations. This leader will also oversee drug product process development for early-stage programs, ensuring that processes are scientifically rigorous, scalable, and positioned for smooth transition into late-stage and commercial manufacturing. In addition, the VP of Manufacturing will author and review manufacturing-related CMC submission sections, lead technical responses to regulatory agencies, and participate directly in regulatory interactions. You will work closely with Quality and Regulatory to prepare for pre-approval inspections (PAIs) and ensure manufacturing and packaging operations meet global regulatory expectations. This role partners closely with Supply Chain to ensure launch readiness, demand planning, inventory strategy, and commercial supply continuity across Loyal's CDMO network. This position reports to the Chief Technical Operations Officer. Your daily work will include Lead all drug product manufacturing and packaging operations from late-stage development through commercial launch and ongoing commercial supply. Oversee process validation, PPQ, and commercial technology transfer to commercial manufacturing sites. Provide oversight and technical guidance for early-stage drug product process development, ensuring scalable, robust, and well-controlled processes. Drive CDMO selection, contracting, and governance, ensuring strong technical performance, quality, and supply reliability. Ensure manufacturing and packaging operations meet GMP compliance, process robustness, and global regulatory expectations. Author and review manufacturing-related CMC regulatory submissions, including process descriptions, validation summaries, commercial readiness content, and container-closure documentation. Lead technical interactions with regulatory authorities, including preparing briefing materials, responding to inquiries, and representing manufacturing during regulatory meetings. Support preparation and readiness for pre-approval inspections (PAIs), including technical documentation, training, and site responses. Partner with Quality to support technical investigations, root-cause analyses, and CAPA development. Contribute to process lifecycle management, including post-approval changes, continued process verification (CPV), and ongoing optimization. Partner with Supply Chain on launch readiness, production planning, technical supply risk assessment, and commercial supply continuity. Build, mentor, and lead a high-performing team supporting manufacturing, packaging, and technical operations. About you PhD in Chemical Engineering or a closely related discipline preferred; MS/BS candidates with extensive relevant experience will also be considered. 15+ years of experience in pharmaceutical/biopharmaceutical manufacturing covering the full product lifecycle - early development, late-stage development, product launch, and commercial manufacturing. Experience in late-stage manufacturing, product launch, and commercial manufacturing oversight is a must. Experience building and scaling commercial manufacturing and packaging capabilities is a must. Experience supporting or overseeing early-stage drug product process development. Proven expertise in small molecule, oral solid dosage manufacturing, including tech transfer, PPQ, and process validation. Strong experience overseeing packaging operations, including packaging readiness and validation. Demonstrated ability to author manufacturing-related regulatory submission sections and respond to agency queries. Experience participating in or preparing for regulatory inspections, including PAIs. Strong understanding of GMP regulations and global manufacturing expectations (FDA, EMA, ICH). Experience leading technical investigations, root-cause analyses, and CAPA development. Demonstrated success establishing governance with CDMOs, including technical and quality oversight. Effective cross-functional leader with strong communication and collaboration skills. Strategic, hands-on leader who thrives in a fast-paced, mission-driven biotech environment. Experience with lifecycle management, continued process verification, and post-launch operations. Nice to have Experience with veterinary or animal health manufacturing. Passion for Loyal's mission to bring science-driven longevity therapeutics to dogs. Salary range: $270,000 - $320,000 Loyal benefits Full-coverage health insurance - medical, dental and vision - for you and your dependents $1,000 home office equipment stipend $1,200/year learning budget for books, courses, etc. $250/month wellness budget for gym, cleaners, spa, food, etc. All 3-day weekends are turned into 4-day weekends 🎉 Unlimited vacation and paid holidays Paw-ternity leave - adopt a dog and get a day off with your new family member 🐶 Competitive salary Company equity options grant for new hires Loyal is founded and led by a first-gen female CEO and is proud to be an equal opportunity employer. We do not discriminate against applicants based on gender, race or color, ethnicity or national origin, age, disability, religion, sexual orientation, gender identity or expression, veteran status, or any other applicable characteristics protected by law. Our values Lean into moonshots We don't settle for incremental change. We have the bravery to take risks and shoot for the impact we want to have. Opportunity is at the intersection We lean into combining disciplines, expertises, and perspectives not normally adjacent. We design our organization to facilitate cross-pollination and cross-collaboration. We reject silos. Expertise without ego Titles do not determine who has a voice. We work on hard technical problems and have a ton of fun while at it. Learning by doing Our path is novel and many things we are doing have never been done before. We lean into MVPs and are open to unexpected outcomes. Lead with context We value leading with context. We equip people with the context and background necessary to make their own decisions and act in the best interest of Loyal. We empower teams to succeed. Empathy and respect for all life Our patients are not just numbers. Our work is intentional, thoughtful, and guided by respect for life. We take our responsibility to pets and pet parents seriously.

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.

The Director, Quality & Compliance Training, is a senior leader within the Learning Center of Excellence under Global Quality. This role is responsible for developing and executing global training strategies for various functions (e.g., Commercial, Finance, HR, Legal, and other General & Administrative areas). The position ensures that learning programs drive business performance, compliance with corporate standards, and foster a culture of continuous development across the organization. **Key Responsibilities:** **Strategic Leadership & Governance** + Define and lead the global training strategy aligned with corporate objectives and quality principles. + Establish governance frameworks for training compliance and operational excellence, including policies and SOPs. + Serve as a key advisor to senior leadership on learning trends, capability-building strategies, and risk mitigation. **Program Development & Delivery** + Design and oversee training programs for Commercial and G&A functions, ensuring relevance and scalability. + Implement innovative learning solutions leveraging adult learning principles, digital platforms, and blended learning approaches. + Ensure training content aligns with corporate standards and supports organizational priorities. **Stakeholder Engagement & Collaboration** + Partner with functional leaders, HR, and Quality to identify learning needs and align initiatives with business goals. + Act as a trusted advisor to senior leadership on training effectiveness and workforce capability development. **Continuous Improvement & Analytics** + Define KPIs and leverage data analytics to measure training impact and drive enhancements. + Stay current with industry best practices, emerging technologies, and evolving business needs to continuously improve learning programs. **Operational Oversight** + Collaborate with training operations teams to ensure efficient delivery and compliance tracking. + Oversee vendor relationships for training services and technology solutions **Qualifications:** + Bachelor's degree required; advanced degree in Life Sciences, Education, Organizational Development, or related field preferred. + 10+ years in pharmaceutical or life sciences industry with significant experience designing and implementing global training programs. + Proven track record in designing and implementing global training programs and managing cross-functional teams. + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA, EMA, etc.). + Proven ability to design and deliver impactful learning programs using adult learning principles. + Experience with learning technologies (e.g., LMS, virtual learning platforms) and data-driven training strategies. + Excellent communication, collaboration, and stakeholder engagement skills. **Preferred Attributes:** + Strategic thinker with a passion for scientific learning and development. + Agile and adaptable in a fast-paced, matrixed environment. + Strong project management and organizational skills. + Committed to fostering innovation, compliance, and continuous improvement through learning. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $164,530.00 - Maximum $245,985.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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.

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 Owns the configuration of the electronic Quality Management System module for audit records. Executes User Assessment Testing (UAT), manages change management, and ensures system documentation is maintained. Executes against GEHC's Central Quality & Regulatory Audit program. This includes scheduling, preparation, execution, reporting, and follow-up activities associated with Central Quality & Regulatory Internal Audits; identification and communication of high-risk issues; reporting compliance concerns and recommended improvements to business leadership; and ensuring audit strategy is executed to current industry practices and regulatory expectations. Supports GEHC Health / Competent Authority audits. This includes preparation, back-room management, tracking of Lessons Learned, and driving follow-up activities. Supports GEHC Quality Management System by defining, tracking, and maintaining metrics to promote early awareness and visibility of Quality & Regulatory issues. Regularly advises management in Central Quality. Requires specialized depth and/or breadth of expertise within a quality or regulatory discipline and ability to influence the development of strategy within own area, including participation in policy formulation. Requires ability to lead functional teams or projects with indirect resources and medium to high risk and/or complexity. Communicates difficult concepts and influences others' options on topics. May guide others to consider a different point of view. Impacts the team's ability to achieve service, quality, and timeliness of objectives. Work is subject to GEHC policy objectives. Uses high level of judgment to make decisions and handle complex tasks or problems. Has ability to assess quality of information given and ask pertinent questions to stakeholders. Able to offer new solutions to problems outside of set parameters and construct and provide recommendations. Uses multiple internal and some external sources outside of own function to help arrive at a decision. Develops self and others by promoting strong Quality & Regulatory practices, providing feedback, training, and mentorship, and collaborating with stakeholders to achieve desired results. Required Qualifications Master's Degree and a minimum of 5 years' experience in medical device and/or pharmaceutical industry; or Bachelor's Degree and a minimum of 10 years' experience in medical device and/or pharmaceutical industry; or will consider a High School Diploma and a minimum of 15 years' of progressive responsibility in medical device and/or pharmaceutical industry. Direct experience configuring, managing, and qualifying an electronic Quality Management System for audit records. Qualified Lead Auditor with active certification. 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 Medical 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 40%. 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 02, 2026

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. Powered by JazzHR HJcnuwxuHE

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

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.

Job Description Director, Clinical Quality Assurance Department: Global Clinical Development Reports To: VP, Head of Global Clinical Operations Position Summary The Director of Clinical Quality Assurance will be responsible for ensuring quality and compliance of Angitia sponsored clinical studies with respect to Standard Operating Procedures, applicable regulatory requirements (FDA, ICH, other country specific requirements) as well as supporting the non-clinical team on ensuring GLP studies are conducted compliantly. This role will work closely with the Heads of Quality Assurance (QA), Clinical Operations and Translational Sciences. This position reports to the VP, Head of Global Clinical Operations but may transition to Quality Assurance as that group grows. Responsibilities Drive and cultivate a culture of quality throughout the company to help ensure compliance with all applicable regulations, guidelines, and corporate standards, policies, and procedures. Provide QA oversight and support to internal staff in support of Angitia sponsored clinical studies and GLP studies. Development and management of processes and controlled documents related to Angitia sponsored clinical studies (clinical operations, clinical development, pharmacovigilance, regulatory) and GLP studies (translational medicine). Prepare for health authority audit readiness. Develop phase-appropriate Clinical QA operating models in accordance with ICH risk-based compliance guidance; set a strong foundation for future commercial operations. Develop and implement audit plans and schedule for clinical study vendors and other study related GxP vendors (CROs, central /specialty labs, imaging, etc.). Oversee and/or perform site and vendor audits to assure quality assurance compliance with regards to all internal as well as applicable regulatory guidelines. Lead selection of contract auditors to perform site and vendor audits as needed. Ensure timely and effective follow up to all identified or assigned quality issues. Conduct QA review of Angitia sponsored clinical study documents, internal controlled documents and vendor documents. Train internal staff on regulatory requirements such as GCP training. Ensure training compliance and completion for Clinical Development, and potentially others. Identify critical compliance and/or business issues related to GxP, CROs, Contract Test Laboratories and manufacturers of critical starting materials. Create and execute remediation strategies and tactical plans as needed using a risk-based approach. Develop and oversee study quality metrics for clinical studies including study risk assessment, mitigation and CAPA management. Coordinate and host all FDA and Health Authority inspections. Ensure all Quality agreements are effectively negotiated to meet the near- and long-term needs of Angitia as agreed with legal, finance and functional heads. May require up to 25% travel. Qualifications BS BA (or equivalent) in a relevant scientific discipline; advanced degree desirable. 10+ years of Biotechnology industry with at least 8-12 years' experience in Quality Assurance, or equivalent levels of education and / or experience. Strong knowledge of GCP, GLP, and ICH clinical study requirements. Experience with both domestic and international clinical studies (CDE, EMA and FDA regulations). Experience building a quality program and quality system in young, science-driven organizations. Experience leading audits of GXP vendors as well as clinical sites. Demonstrated problem-solving and critical thinking skills. Excellent interpersonal, written and verbal communication skills. Excellent computer skills in the following programs: MS Word, PowerPoint, Excel. And others. Able to travel domestically and internationally up to 25% of the time. Salary: $200,000 - $230,000 About Angitia Established in June 2018, Angitia Biopharmaceuticals is a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for serious musculoskeletal diseases. Angitia is currently studying 3 biologic product candidates in the clinic for the treatment of osteoporosis, osteogenesis imperfecta (OI), and spinal fusion. Leveraging the team's extensive experience and scientific acumen in novel drug development, Angitia is committed to providing groundbreaking therapies to satisfy key unmet medical needs. The founder and the core team members of Angitia are seasoned scientific leaders in new drug discovery, development, and management from both overseas and domestic large multinational companies. The company has built an organization with offices in Westlake Village, CA and Guangzhou, China that is distinguished by world-class scientists with talents that are proficient in the pathophysiology of musculoskeletal diseases. We utilize cutting-edge technologies of genetics and molecular biology to uncover new mechanisms, signal transduction pathways and their interactions combined with computer aided drug design to identify new drug targets, and to discover and develop new biological and small molecule medicines. The company is committed to serving patients in need by carrying out innovative science including internal research and external collaborations with academics and global biopharmaceutical companies. We are seeking talented individuals who are innovative, ambitious, and great team players to join our vibrant group. Learn more at ******************* Benefits: Medical, dental, and vision coverage for employees and their eligible dependents 401(K) Retirement Plan with Company match Company paid Long Term Disability Coverage Company-paid life Insurance & AD&D Coverage Voluntary Life Insurance & AD&D Coverage Employee Assistance Program (EAP) Company-paid Holidays Vacation Paid Sick Leave Telecommunication Monthly Stipend Work-From-Home Equipment Reimbursement

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.

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

Job Description National Technologies (NTI), a Network Connex Company, is a premier turnkey installer of fiber optic and data center infrastructure. Working on our team puts you on the leading edge of innovation in the digital communications space. If being a part of a tight-knit organization that operates in some of the most advanced technology environments around the world sounds like a dream job, NTI might be the right fit for you! With the perks of a large organization, NTI remains true to its roots as a home-grown company with an open door culture that welcomes new ideas and encourages professional growth. We set you on the right path with careful onboarding and thorough training programs that prepare you for success in your role and beyond. Job Summary: As a Quality Assurance/Quality Control Manager, you will be responsible for managing the QA/QC Program for the Ohio market with the ability to travel to other markets and assist when necessary. This role involves developing and maintaining quality standards, performing inspections, managing quality-related documentation, and ensuring that all work complies with NTI standards. Job Duties and Responsibilities: Responsible for the start-up and implementation of the Quality Control Process. Interface directly with company and customers Quality Assurance (QA) and management on all quality related issues. Be technically experienced and capable of comprehending the specifications, standards, and code requirements for all assigned projects. Review all potential deficiency reports, track discrepancies, and verify the issues have been fully corrected prior to closure. Develop the Preparatory Meeting agendas, facilitate the Preparatory Meetings and participate in the Initial, Follow-up and Final Inspections. Be fully aware of the contract, plans, specifications, and applicable codes. Perform daily/weekly field inspections to verify employees work complies with the project specifications and applicable codes. Document and submit a Weekly Report of Quality Control activity. Perform material inspections to verify that the products are to specifications and that storage, staging and material handling methods are implemented. Audit quality control procedures. Work closely with the Health and Safety team to ensure a safe working environment for all employees and subcontractors. Provide hands-on coaching and feedback to the field technicians to reinforce quality standards. Identify reoccurring issues and collaborate on process improvements. Develop risk mitigation strategies to minimize project-related quality issues. Personnel evaluation and development for QA/QC team. Job Knowledge, Skills, and Abilities: Excellent verbal and written communication skills. Excellent organizational skills and attention to detail. Excellent time management skills with a proven ability to meet deadlines. Strong analytical and problem-solving skills. Ability to prioritize tasks and delegate them when appropriate. Excellent leadership skills. Proficiency in relevant software tools and quality control systems. Strong commitment to safety and quality. Proficient with Microsoft Office Suite or related software. Education and Experience: Certification in Quality Assurance or Quality Control is a plus. Proven experience in QA/QC roles within the industry, with a minimum of 4 years of experience. Strong knowledge of codes, standards, and regulations. Physical Requirements: Must be able to carry and lift items weighing up to 25 pounds. Pay rates may vary based on skills, background, experience and specific location. NTI provides a comprehensive benefits package including health, dental, vision, life, and disability insurance and retirement savings options. For Union employees, pay rates and benefit levels are determined by union classifications which are set by the union. National Technologies (NTI) believes all persons are entitled to equal employment opportunities and does not discriminate against employees or job applicants because of race, color, gender, affectional or sexual orientation, domestic partnership status, ancestry, religion, national origin, citizenship status, marital status, disability, veteran status, age or any other protected group status. Upon acceptance of an offer, all candidates will be required to pass a background check and drug screening.

Job Summary:The Director of Quality Assurance is responsible for shaping and leading the vision, strategy, and execution of quality practices across the organization. This role is both strategic and hands-on, requiring a leader who can set long-term direction while also engaging with teams at a detailed level to ensure quality is embedded in every stage of the development lifecycle. The Director will unify and mature QA processes across multiple empowered squads, ensuring consistency in philosophy, practices, and measurement, while still supporting the flexibility and autonomy of individual teams. This leader will oversee all aspects of testing-including functional, regression, performance, and automation-to safeguard reliability, usability, and performance across our products. They will establish clear, visible quality metrics that allow the business to balance speed, risk, and customer satisfaction, while continuously seeking opportunities to improve efficiency and scalability. Beyond process, the Director will be a culture-builder and mentor, developing a high-performing QA organization through coaching, hiring, and professional development. They will work closely with product, engineering, design, and business stakeholders to ensure shared ownership of quality outcomes, inspire cross-functional alignment, and strengthen the feedback loop between QA, development teams, and end users. Ultimately, this role ensures that our software is delivered with excellence-delighting customers, reducing defects, accelerating delivery, and enabling teams to consistently ship high-quality products at scale.Responsibilities: Performance Outcomes Testing Excellence Define and execute a unified QA strategy across squads to ensure consistent, effective testing practices. Oversee functional, regression, performance, and automated testing to prevent defects and improve product reliability. Conduct testing to identify defects, usability issues, and risks before release. Collaborate with product, engineering, and design to clarify requirements, acceptance criteria, and definition of “done.” Measurement and Documentation Establish, track, and report on key quality metrics including defect rates, defect density, test coverage, cycle time, and product reliability. Ensure defects are documented accurately and comprehensively. Monitor and communicate test results and quality trends across teams and stakeholders. Maintain clear, visible documentation of processes, decisions, and tools. Process Improvement Continuously evaluate and refine QA processes to enhance efficiency, scalability, and effectiveness. Identify opportunities for automation and implement modern testing frameworks and tools. Stay current with industry best practices, methodologies, and emerging technologies. Participate in retrospectives and drive continuous improvement across engineering practices. Collaboration and Cross-Functional Partnership Build strong partnerships with product managers, engineers, design, and other stakeholders to ensure usability, performance, and functionality meet expectations. Provide actionable feedback to improve product quality and user experience. Promote a culture of quality and accountability throughout the organization. Share knowledge and foster collaboration through workshops, training, and documentation. Team Leadership and Development Hire, mentor, and develop QA professionals, fostering career growth and engagement. Create a high-performing, collaborative team culture focused on learning and continuous improvement. Inspire and empower team members to innovate and take ownership of quality outcomes. Monitor team health and engagement through feedback and metrics such as team NPS. Education, Knowledge, and Experience 10+ years of QA/test engineering experience, including leadership roles. Proven track record of building and scaling QA teams in modern software environments. Deep knowledge of QA methodologies, testing strategies, and SDLC/STLC. Hands-on experience with automation frameworks, performance testing, and modern QA tools. Strong technical understanding of web/mobile technologies, APIs, and databases. Excellent communication, leadership, and collaboration skills with a coaching-oriented approach. Demonstrated success in driving measurable improvements in product quality and QA processes. FLSA Status Exempt Physical Requirements/ Work Environment Employee must be able to sit or stand for long periods of time, with the physical ability to work at the computer or other sedentary tasks for long periods of time. Employee can conduct duties discreetly and impartially. If working remotely, employee is able to work in a space that allows them to effectively complete their job tasks, including having reliable internet connectivity and the ability to participate effectively while on phone and video calls. Employee has regular and predictable attendance and punctuality. Additional Information:Location:Remote Job PostingDepartment:9310 EngineeringTime Type:Full time Commitment to Equal Opportunity PPLSI conforms to all the laws, statutes, and regulations concerning equal employment opportunities. We strongly encourage women, minorities, individuals with disabilities and veterans to apply to all of our job openings. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, status as a protected veteran, and basis of disability or any other federal, state or local protected class. We prohibit retaliation against individuals who bring forth any concerns, orally or in writing, to the employer or the government, or against any individuals who assist or participate in the investigation of any concerns or otherwise oppose discrimination. If you require a reasonable accommodation to complete the application process, please contact Human Resources at: **********************************.

Hello Heart is on a mission to change the way people care for their hearts. The company provides the first app and connected heart monitor to help people track and manage their heart health. With Hello Heart, users take steps to control their risk of heart attacks and stroke - the leading cause of death in the United States. Peer-reviewed studies have shown that high-risk users of Hello Heart have seen meaningful drops in blood pressure, cholesterol and even weight. Recognized as the digital leader in preventive heart health, Hello Heart is trusted by more than 130 leading Fortune 500 and government employers, national health plans, and labor organizations. Founded in 2013, Hello Heart has raised more than $138 million from top venture firms and is a best-in-class solution on the American Heart Association's Innovators' Network and CVS Health Point Solutions Management platform. Visit ****************** for more information. About the Role: As Manager, Quality and Manufacturing, you will own both quality engineering and manufacturing engineering functions for our hardware products. You will ensure production readiness, product quality, process capability, and smooth issue resolution from prototype through mass production. Reporting into our Senior Director, Product and Manufacturing Operations, you will collaborate closely with suppliers, engineering, program management, and operations teams. You will create the structure, tools, and processes that enable consistent, high-quality manufacturing outcomes. Responsibilities Validate manufacturing readiness for NPI builds, including tools, fixtures, process flow, and documentation Partner with engineering teams on DFM and DFA reviews, qualification testing, and readiness milestones Create and maintain quality control plans across IQC, IPQC, and OQC processes Define and implement manufacturing process controls, test requirements, and build validation plan Lead structured root cause analysis using 8D, 5 Why, and Fishbone methodologies Drive corrective and preventive actions and verify long-term effectiveness Conduct line audits, capability studies (Cp and Cpk), and SPC monitoring to assess process health Monitor yields, reduce defects, and drive continuous improvement across production lines Assess supplier capability and lead onsite production reviews and factory evaluations Define incoming inspection criteria, sampling plans, and supplier quality alignment Maintain detailed build documentation, quality dashboards, and audit reports Qualifications 7+ years of experience in quality engineering, manufacturing engineering, or a related hardware-focused discipline Hands-on experience with production lines, fixtures, test equipment, and hardware manufacturing processes Strong understanding of quality systems including ISO 9001, ISO 13485, PFMEA, SPC, and Six Sigma Proven experience leading root cause analysis and driving corrective actions Experience working with contract manufacturers and suppliers, preferably in Asia Strong analytical skills with the ability to interpret yield trends, SPC data, capability studies, and defect data Excellent communication skills with the ability to present findings and recommendations Experience supporting NPI builds and high-volume product ramp is preferred Familiarity with reliability testing and environmental qualification is preferred Knowledge of hardware system integration spanning mechanical and electrical components is preferred Experience with DOE, process optimization, or Lean Manufacturing is preferred Mandarin language proficiency is a plus The US base salary range for this full-time position is $140,000.00 to $160,000.00. Salary ranges are determined by role and level. Compensation is determined by additional factors, including job-related skills, experience, and relevant education or training. Please note that the compensation details listed in US role postings reflect the salary only, and do not include equity or benefits. Hello Heart has a positive, diverse, and supportive culture - we look for people who are collaborative, creative, and courageous. Oh, and if you want to see some recent evidence of the fun things we do at Hello Heart, check out our Instagram page.

As an essential business, Anomatic produces innovative and sustainable packaging for today's biggest brands. By leveraging over five decades of manufacturing expertise and employing an extensive technologies portfolio, we design, manufacture, and finish incomparable stock and customized solutions for numerous markets. Position: Director, Quality Assurance Location: Newark, OH Department: Quality Reports to: COO _____________________________________________________________________________ JOB SUMMARY This position is responsible for the overall quality manufacturing processes within a multi-plant, lean manufacturing organization. The role is responsible to facilitating and driving consistent quality processes within plants, internal and external continuous improvement, and leveraging strong interpersonal and technical skills for the betterment of product outcomes. This role has key leadership responsibilities for quality improvement initiatives across multiple sites that include black and green belt development, project implementation and cultural change. ESSENTIAL FUNCTIONS - Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. Lead the establishment and maintenance of statistical process control procedures and drive actions on trends or variances outside established limits that require corrective action. Lead the development and/or refinement of Lean based FMEA and quality plans for inspection, test, and evaluation of materials, processes and products across the divisions' various plants and operations. Devise statistically sound Lean sampling procedures and implement systems for recording, evaluating, and reporting quality and reliability data. Lead the quality organization and its interaction with other company departments, suppliers and customers on matters related to materials, processes or products which impact product quality and reliability objectives. Focus on business performance improvements that yield zero accidents, defect free products, on demand and on time delivery, at the lowest cost. Work as a coach / mentor to develop less experienced quality staff Establish the climate that encourages an open two-way channel of communication whereby employees exchange ideas / suggestions and share information Education and Experience Bachelor's degree in engineering or technical degree from an accredited university. 5+ years of experience in a manufacturing environment in a quality leadership role. Expert in use and application of key quality tools (DOE, SPC, FMEA, 8D, etc.) Ability to lead & implement ISO/TS & Lean Manufacturing methodologies. Experience in a high tolerance, aesthetic product background. Competencies Excellent written & verbal skills Results Driven Influence & Persuasive Skilled Change Management Process Focused Presentation Skilled Anticipates Early Deadline driven Multitasker Analytical Skills Benefits you can expect from Anomatic: Competitive Pay Career Growth Health Coverage Starting Your First Day 401K with Company Match, to help save for the future Paid Time Off to Enjoy Family or Hobbies DailyPay, to get your money faster Training, to help hone skills Many more! WHO WE ARE. Our VISION “To inspire the world of consumer packaging”. Our MISSION Anomatic will ensure a work environment that is committed to team safety, low environmental impact and use of sustainable materials. We will respect our customers' need for innovative quality assured products delivered on time, complete and error free. Leadership will foster a culture that empowers the team to act with a sense of urgency in driving solutions. We will be collectively accountable to each other, our customers and the communities where we live and work. Our associates will act with integrity and transparency in everything we do, and we will work harder than anyone else in the industry to earn our customers' trust every day. Our VALUES Respect Integrity Accountability Work Ethic Urgency Trust Anomatic takes pride in creating a safe and inclusive environment that encourages, supports, and celebrates the diverse voices of our employees and the communities in which they live. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, or Veteran status. #1Anomatic

The primary function of the Quality Program Manager is responsible for providing day to day management of the quality improvement program. Responsible for coordinating activities of quality department staff, suggesting process changes, measuring data, and completing QA activities to achieve organization goals for quality measures for programs like UDS, Accountable Care/Clinically Integrated Networks, Ohio Medicaid CPC, CPC Kids, CMC, and individual insurance plan contracts. Reports to: Director of Quality and Clinical Systems Supervises: Yes Dress Requirement: Business Casual Work Schedule: Monday through Friday during standard business hours Times are subject to change due to business necessity Exempt Essential Job Duties and Responsibilities Work with supervisor and members of clinical leadership to develop, implement, monitor, and measure plans to improve processes and quality outcomes. Work with supervisor, clinical leadership, data analytics team, and external data vendor Unity PHM to analyze data, clean data, and perform quality assurance activities. In collaboration with supervisor, Chief Medical Officer, and others, the position is responsible for carrying out system-wide quality programs. Assists with developing, planning, and implementing policies and procedures. Works closely with supervisors, clinical teams, and non-clinical teams for quality improvement efforts. Assists with designing processes for quality improvement purposes. Plays a key role in maximizing revenue from value-based care, pay-for-performance, and risk adjustment contracts. Ensure compliances with program requirements. Examples include individual insurance plan contracts, Accountable Care/Clinically Integrated Networks, Ohio Medicaid CPC, CPC Kids, and CMC programs. Focuses on better healthcare value and quality, including the improvement of clinical outcomes, patient experience, patient safety, costs, revenue, productivity, efficiency, employee and physician satisfaction, and process reliability. Leads or participates in meetings related to quality improvement. Coordinate, manage and report UDS measures and other data related to clinical quality. Manages performance improvement projects to assure milestones and key performance indicators are met within defined parameters. Documents the results of projects, and submits other documentation as requested. Develop and motivate department staff. Interview, monitor time and attendance, and manage performance of subordinates. Report on clinical quality measures internally and externally. Provide updates to internal and external stakeholders on progress in quality initiatives. Support data collection and reporting related to grants. This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned at any time with or without notice. Qualifications Education: Bachelor's degree in a related field required. Examples include nursing, healthcare administration, public health, or similar. Certifications such as CPHQ and Lean Six Sigma are beneficial, but not required. Experience: At least four years of experience in the healthcare field, quality, data analytics, and/or management strongly preferred. Master's level education and appropriate background may substitute for some experience. Knowledge of clinical operations including the functions of the front and back-office utilization information systems is preferred. Previous experience working in an outpatient clinic is preferred. Knowledge/Abilities: Excellent communication skills, both written and verbal, are required. Strong organization and time management skills are required. Ability to work independently and demonstrate initiative is required. Proficiency with Microsoft Office is required. Displays cheerful demeanor and makes positive comments when on duty. Works cooperatively with other staff members. Displays sensitivity in a multi-cultural environment. General understanding of the medical billing process is preferred. Equipment Operated : Telephone Computer Printer Fax machine Copier Other office equipment as assigned Other office and medical equipment as assigned Facility Environment : Heart of Ohio Family Health operates in multiple locations, in Columbus, OH. All facilities have a medical office environment with front-desk reception area, separate patient examination rooms, nursing stations, pharmacy stock room, business offices, hallways and private toilet facilities. All facilities are ADA compliant. The patient examination rooms and office area is: kept at a normal working temperature sanitized daily maintains standard office environment furniture with adjustable chairs maintains standard office equipment; i.e., computer, copier, fax machine, etc. at a normal working height Physical Demands and Requirements : these may be modified to accurately perform the essential functions of the position: Mobility = ability to easily move without assistance Bending = occasional bending from the waist and knees Reaching = occasional reaching no higher than normal arm stretch Lifting/Carry = ability to lift and carry a normal stack of documents and/or files Pushing/Pulling = ability to push or pull a normal office environment Dexterity = ability to handle and/or grasp, use a keyboard, calculator, and other office equipment accurately and quickly Hearing = ability to accurately hear and react to the normal tone of a person's voice Visual = ability to safely and accurately see and react to factors and objects in a normal setting Speaking = ability to pronounce words clearly to be understood by another individual

Nature and Scope Reporting to the, QA Operations & Quality Systems Director, the QA Release Senior Manager focuses on final release of all components, materials, and products utilized and produced at American Regent sterile manufacturing plants and laboratories. This position is also responsible for oversight of activities of Contract Manufacturing Organizations (CMO) finished product manufacturing and their adherence to established Quality and Compliance requirements. This is a multi-disciplinary management role that will interact with all phases of production including manufacture of sterile injectables, laboratories, facilities/engineering, and materials at three different American Regent sites in the Columbus, Ohio area. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. * Perform all duties in accordance with American Regent and Daiichi Sankyo Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines. * Manage and assign QA staff in incoming, in-process, final inspection, and batch release. Includes the inspection & sampling of raw materials, finished products, and components. Is directly responsible for batch releases. * Oversee GMP activities of Contract Manufacturing Organizations (CMO) finished product manufacturing and ensuring conformance to established Quality and Compliance requirements. * Ensures oversight for the successful life cycle development and commercialization of pharmaceuticals at external manufacturing partners. * Act as a liaison between QA and other departments on quality issues related to release of incoming, in-process, and final products and report back to the QA Operations & Quality Systems Director. * Initiation, review and approval of cGMP documentation including: procedures, policies, change controls, deviations. * Develop and manage quality metrics to optimize performance, identify trends, and communicate to Senior level Management. * Identify quality process improvements to increase efficiencies and performance of systems, operations and personnel. * Identifies and resolves potential cGMP issues which may impact quality and reports results to Senior level Management. * Consistently demonstrate QUALITY culture and behaviors and perform all duties in accordance with American Regent and Daiichi Sankyo Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines. * Ensures all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP and health and safety requirements in the markets where product is sold. * Ensures Quality Assurance goals and objectives are identified and met * Act as a liaison between American Regent QA and third-parties on quality issues and report back to the QA Operations & Quality Systems Director * Provide effective leadership including: individual goal setting/performance reviews, managing the development of employees, recognizing and appreciating employee contributions, mitigating conflict and communication problems, planning and facilitating team activities, selecting personnel and motivating members of the functional area. * Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. * Bachelors' degree in Life Science or equivalent course of study is required. * 10 years progressive experience in QA Pharmaceutical environment required. * 5-10 years management experience required. * Strong working knowledge of Federal (FDA) Good Manufacturing Practice (GMP) requirements and guidelines and documentation practices. * Excellent oral and written communication skills including strong technical writing skills. * Strong organizational skills, planning skills and team-building. * Ability to work independently and deliver timely results. * Ability to lead cross functional teams, resolve conflicts and disagreements. * Ability to travel between each of the Ohio facilities (in the greater Columbus area). American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. * FMLA poster: ********************************************************** * Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) * Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: * All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. * Our recruiting process includes multiple in person and/or video interviews and assessments. * If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. * We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.

Job Title: Senior Food Safety and Quality Program Manager Department: Compliance Reports To: Sr. Director of Compliance Job Type: Full time Travel: 20%-30% Compensation: pay range- $89,000-$111,000 based off experience Job Summary The Senior Food Safety and Quality Program Manager is responsible for developing, implementing, and improving comprehensive food safety and quality assurance programs across Versova's shell egg facilities. This role leads the QA team, ensures regulatory compliance, and promotes a culture of food safety throughout the organization. Essential Job Functions Develop, implement, and improve food safety and quality assurance programs Manage and develop QA personnel, ensuring adequate staffing for all processing shifts Ensure compliance with SQF, FDA, USDA, state, and customer regulations/standards Conduct routine reviews with operations management and lead third-party audits Provide training for QA team and operations personnel on food safety and quality assurance Investigate and resolve customer complaints and nonconformities Perform routine internal audits of shell egg facilities Serve as SQF Practitioner for shell egg facilities Promote a culture of food safety through operational engagement Collaborate with cross-functional teams to integrate food safety into all aspects of operations Stay current with industry trends and emerging food safety technologies Other duties as assingned Required Qualifications Bachelor's Degree in a related field (Quality Assurance, Food Science, Biology, Operations Management, etc.) or commensurate experience 7-10 years of experience in food safety and 5+ experience managing personnel HACCP certification (or ability to become certified) SQF certification (or ability to become certified) Excellent communication skills and proficiency in Microsoft Office suite Preferred Qualifications Experience in egg processing industry Demonstrated ability to gain employee buy-in for compliance programs Working knowledge of state and federal regulations related to food production Work Environment This role requires regular travel to our egg processing facilities. The position involves work in various climate conditions, including extreme heat and cold environments. Physical requirements include the ability to lift 50lbs and stand or walk for extended periods. The work environment is fast-paced and requires adaptability to manage multiple priorities in food safety and quality assurance. About Us: Versova is one of the largest egg producers in the United States, bringing together family-owned farms in Iowa, Ohio, Washington, Oregon, Idaho, Utah, and Colorado. With over six decades of industry experience, our team of more than 2,000 employees is dedicated to exceptional flock care, environmental stewardship, and producing safe, high-quality eggs. More than just a workplace, Versova is a team built on shared values, working together to enrich our communities and uphold the highest ethical standards. As a family of companies and a company of families, we are guided by a strong set of Core Values: Recognition, Initiative, Safety & Security, Service, Community, Respect, Integrity, Ownership, and Excellence. These values drive our commitment to responsible employment, sustainability, and industry innovation. When you join Versova, you become part of something bigger - working together to lead the future of egg production with integrity and excellence. Benefits: Regular performance reviews Health insurance Dental insurance Vision insurance HSA with company match Paid time Off Paid Holidays 401K with company match Tuition Reimbursement Employee Assistance Program Posting Statement All qualified applicants will receive consideration for employment without regard to race, color, religion, religious creed, sex, national origin, ancestry, age, physical or mental disability, medical condition, genetic information, military and veteran status, marital status, pregnancy, gender, gender expression, gender identity, sexual orientation, or any other characteristic protected by local law, regulation, or ordinance. Disclosure This job description is not exhaustive, as employees may perform additional related duties as needed. Employment is based on an 'at-will' basis. Employment is contingent upon the successful completion of a background check, as applicable to the role and in compliance with local, state, and federal laws.