Quality Assurance Manager jobs at Res-Care Premier - 853 jobs

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 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: $1****76,000 - $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 #J-18808-Ljbffr

A leading pharmaceutical company in San Diego seeks a Director, Quality Assurance (GCP) to oversee GCP QA systems, ensuring compliance with regulatory requirements. The role demands extensive experience in GCP as well as a strong leadership and auditing background. The ideal candidate will have a track record of developing quality strategies and collaborating across multiple teams. Competitive compensation includes a salary range of $176,000 - $220,000, alongside comprehensive health benefits and additional perks. #J-18808-Ljbffr

A global biotechnology company is seeking a Director of R&D Quality Governance & Risk Management to lead and enhance the governance framework supporting risk-based decisions. This strategic role requires 10+ years of R&D QA experience, strong leadership presence, and operational agility. Candidates should possess exceptional collaboration skills and mentorship capabilities. The role offers flexibility in a hybrid work environment with competitive compensation and comprehensive benefits. #J-18808-Ljbffr

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team. The Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited to Manufacturing, Quality Control laboratories, and Warehouse Operations. The Specialist, QA Shop Floor, Cell Therapy will oversee and partner with operational areas, to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. Shifts Available: 6pm - 6am, rotating scheduling including holidays and weekends, onsite Responsibilities: Provide routine Quality on-the-floor oversight and triage unexpected events with Manufacturing, Quality Labs, and Supply Chain operations. Able to interpret problems and effectively prepare surrounding communication in a productive manner to management and to the group with clarity, brevity, and accuracy. Identify departures from approved procedures and respond to issues independently while escalating complex issues to senior members. Perform and document operational verification within Manufacturing Execution System (MES) per approved procedures. Observe manufacturing operations and identify departures from procedures, cleanroom behaviors and aseptic techniques. Provide quality oversight for pre-planned return to service plans. Perform area walkthroughs to identify quality issues, propose remediations and support implementation plans with area owners. Identify and propose improvements to programs, procedures, and practices. Review manufacturing batch records or QC testing records to ensure compliance with approved procedures. Review and provide feedback on documents such as forms, logbooks, and procedures. Maintain compliance with assigned learning plan. Provide integration support of newer team members. Independently approve deviation records within the quality management system consistent with quality risk management principles and in accordance with process knowledge Review and interpret the technical conclusions of a record/investigation and provide constructive feedback. Participate in quality and shift meetings. Build and maintain relationships with core partner functions and seek collaborative solutions. Share data/knowledge within team by acting as a champion for quality-culture. Knowledge and Skills: Must be action-oriented and proficient in decision-making, building relationships, problem-solving, and analytical thinking. Ability to understand, follow, and apply internal policies, procedures, and quality principles. Prior experience with quality processes, including batch record review, material disposition, change control, product complaints, deviations, investigations, and CAPA management. Ability to assess an unfolding situation, diagnose the problem, and propose practical solutions. Detail-oriented and task-focused with the ability to meet deadlines and prioritize assigned work. Ability to work in a fast-paced team environment with changing priorities with limited information and/or time-constraints. Effectively communicate with cross-functional peers and various levels of management through technical writing and verbal skills. Active listening skills to understand diverse working perspectives. Contributes to a positive team environment. Able to independently make decisions based on data and facts, and recognizes when to escalate Seeks opportunities for improvement to quality and operational problems. Ability to work within pharmaceutical cleanroom environments. Experience with quality management systems for handling of records such as change control, product complaints, deviations, investigations, and CAPA management. Experience with GxP electronic systems such as Manufacturing Execution Systems (MES) for electronic batch records; Enterprise Resource Planning (ERP) such as SAP; laboratory information management systems; or electronic logbooks/forms. Proficient with digital tools like Microsoft Power Automate, Smartsheet, Tableau, etc. Basic Requirements: Bachelor's degree in STEM field. High school diploma or associate's degree with equivalent combination of education and work experience is considered. 2+ years of relevant cGMP experience with 1+ year of manufacturing site experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing. * BMSCART #LI-ONSITE GPS_2025 If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: Devens - MA - US: $83,540 - $101,228 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit ************************************* Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to **************************. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: ********************************************* Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Breaking Data is a boutique healthcare marketing agency serving leading pharmaceutical, biotech, and medical device companies. We specialize in scientific storytelling, creative strategy, and high-impact communications that bring complex brand narratives to life across print, digital, and training platforms. Founded by marketers, for marketers, we pride ourselves on delivering thoughtful, intuitive, and beautifully executed work. Our team is full of “A-teamers”: curious, collaborative, detail-driven people who care deeply about the craft and the quality of what we create. We believe co-location fuels creativity, alignment, and culture. While we offer flexibility, this role is intended for someone who can work 3 days onsite in our Cherry Hill, NJ office and 2 days remote. Senior Editorial and Quality Lead (Healthcare Agency)| Boutique Life Sciences Agency Location: US-Cherry Hill, NJ Employment Type: Full-time Benefits: Health Insurance Compensation, 401K program, Paid time off, and company holidays Opportunity Overview Breaking Data seeks a meticulous Senior Editorial and Quality Lead to serve as the central hub for editorial excellence across pharmaceutical and healthcare deliverables. This hands-on role owns quality control from post-writing drafts through design, reviews, and client approvals-focusing on grammar, style mastery, layout accuracy, and workflow efficiency. Ideal for an experienced editor passionate about the craft of editing. About the Role The Senior Editorial and Quality Lead will own editorial quality control as the central hub across all deliverables-from post-medical writing drafts through design layouts, internal strategy reviews, and client approvals. This hands-on role encompasses proofreading, light editing, layout verification, and workflow coordination for slides, print materials, digital assets, training modules, and long-form content, serving pharmaceutical and healthcare clients. Work closely with medical writers, designers, strategists, and account teams to ensure grammar, style, accuracy, and layout integrity meet the highest agency and client standards. Key Responsibilities Editorial Quality Control Proofread and edit copy developed by medical writers for grammar, clarity, consistency, spelling, accuracy, AMA Manual of Style, and client-specific guidelines. Verify references, superscripts, citations, medical terminology, numeric values, units, symbols, and data formatting. Perform light editing or rewrites to address minor issues and maintain project efficiency. Brand & Compliance Consistency Ensure content aligns with each client's editorial style, tone, branding expectations, and regulatory requirements (including PI/ISI placement when applicable). Confirm correct application of references, anchors, superscripts, and citation formatting. Design & Layout Review Review designed documents and slides (PowerPoint, InDesign, PDFs) to confirm clean, consistent formatting and layout. Verify alignment between copy and design elements (tables, charts, visuals, callouts); identify inconsistencies in spacing, bullets, alignment, superscripts, or content order that could alter meaning. Process & Workflow Execution Manage editorial checkpoints and coordinate handoffs across medical writers, designers, internal strategy reviewers, and clients on multiple concurrent projects. Implement QC edits directly; track and ensure all internal, client, and MLR feedback is accurately incorporated with proper version control and file naming. Serve as the final quality assurance step before client delivery. Requirements Minimum 4-5 years of editorial or proofreading experience in a healthcare, pharmaceutical, or medical communications agency setting. Strong knowledge of the AMA Manual of Style and the ability to apply client-specific style guides and branding requirements. Experience reviewing healthcare or scientific content with a high level of accuracy for terminology, data, units, and references. Demonstrated ability to manage multiple projects and deadlines in a fast-paced, detail-oriented environment. Proficiency in Microsoft Office, Adobe Acrobat Pro, and cloud-based document systems (eg, SharePoint/OneDrive). Exceptional attention to detail and a commitment to editorial precision and quality control. Strong communication and collaboration skills for working with medical writers, designers, strategists, and account teams. Education Bachelor's degree in English, Communications, Journalism, or a related field; a life sciences background is a plus but not required for this role. Work environment Our Cherry Hill, NJ office offers a flexible and collaborative environment. We align projects with each team member's core skills, striking a balance between fun and efficiency to achieve our goals and those of our clients. This is a hybrid position, with 3 days onsite and 2 days remote. Application Process To apply, please submit your resume (and, if available, editing samples) directly through this LinkedIn job posting. Candidates selected for the next steps will be asked to complete a brief editing exercise.

A leading global biotechnology firm in Boston seeks a Principal Engineer to lead the automation of pre-clinical data pipelines and regulatory reporting solutions. This role focuses on driving modernization and standardization initiatives, leveraging AI technologies, and enhancing data consumption practices. Candidates should possess strong programming skills and a degree in a relevant field, with a minimum of five years in technical leadership within the biotechnology industry. The position offers a hybrid work model and a comprehensive benefits package. #J-18808-Ljbffr

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. The Manager, Biologics External Manufacturing Quality provides quality oversight for Eisai's biologics products manufactured at external partners (CMOs), covering Drug Substance (DS) and Drug Product (DP) including aseptic fill finish. The role ensures compliance with global GMP requirements and Eisai standards across product lifecycle, from cell banking and upstream/downstream processing through aseptic filling, packaging and release. The manager acts as Eisai's Quality contact for assigned sites, driving batch disposition readiness, deviation/CAPA governance, complaint management and proactive risk management to safeguard patient safety. The position collaborates with supply chain, technical operations, and CMC Program Management to review and support approval of deviations, change controls, batch records, validation protocols, quality agreements, and regulatory documentation. The Manager assists with batch disposition and supports external audit activities. Essential Functions: Review and approve batch records for DS and DP manufacturing, ensuring compliance and data integrity. Assess and approve deviations, investigations, and CAPAs related to DS and DP operations (e.g., EM excursions, media fill failures, process deviations). Oversee change controls impacting DS and DP processes. Support batch disposition activities to ensure timely and complaint product release. Monitor and track manufacturing data for integrity and compliance. Ensure CMO compliance with quality systems (change control, deviations, investigations, OOS results, validation, retain sample management). Contribute to evaluation of product complaints and regulatory compliance of CMOs. Review technical protocols, reports, batch records, and regulatory documentation related to DS and DP manufacturing and validation activities. Support development and maintenance of processes and procedures governing quality systems and CMO interactions. Collaborate with internal and external stakeholders to drive compliance, continuous improvement and risk mitigation across external manufacturing operations. Requirements: Education: BS/BA in life sciences or engineering (required); advanced degree desirable. Experience: 5+ years of Quality experience in biologics DS and DP operations, including aseptic fill-finish. Knowledge of EU GMP Annex 1 & Annex 2, FDA aseptic guidance, and global sterility assurance principles. Experience with DS processes (cell culture, purification) and DP aseptic operations (media fills, EM trending, contamination control strategies) Understanding of Quality System Management (lot disposition, deviations, change management, complaints). Strong organizational and communication skills; ability to manage multiple priorities. Proficiency in Microsoft Office tools. Ability to travel up to 25% (domestic and international). Required onsite Tuesday-Thursday Eisai Salary Transparency Language: The annual base salary range for the Mgr., Biologics External Mfg. Quality (Hybrid) is from :$104,800-$137,600Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ********************************************************** Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: Right To Work E-Verify Participation

SummaryJob Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. The Quality Assurance Manager has the responsibility of managing and developing the QA Team in Irvine, CA. The individual provides Quality Engineering/Systems leadership to support Operations and to drive continuous improvement while ensuring compliance to procedures and requirements. The daily tasks associated with the role are incoming quality control, manufacturing, materials management, labeling, and product disposition management along with maintenance of the quality system. Essential duties and responsibilities: Manages QA department and overall expectations pertaining to setting accurate schedules, costs and resources. Ensures department is adequately resourced and trained to perform jobs effectively. Directly supervises QA staff including mentoring and developing to enable maximum performance and individual employee growth, providing regular performance review and feedback and using corrective action as necessary. Ensures delivery against QA department goals and objectives, i.e. meeting commitments and coordinating overall quality assurance schedule. Encourages a team environment, leads by example and demonstrates servant leadership skills. Prepares and maintains department budgets. Serves as a team member to provide quality engineering expertise to continuous improvement teams and manufacturing support. Implements ongoing quality improvement processes working with interdepartmental teams. Develops project schedules and resource allocation models for QA related projects and other activities to support project teams. Provides effective communication regarding issues, objectives, initiatives and performance to plan. Develops inspection and process control procedures, processes through document control and provides training for the procedures. Develops metrics to identify and prioritize activities pertinent to process control, risk reduction, and cost improvement. Manages non-conformance data and provides oversight for corrections, trending, tracking, external communications, closure and reporting. Develops, tracks, trends, reports and maintains Quality Indicators to enhance quality of products and business performance. Facilitates communication and teamwork between R&D/NPD and Operations, towards the purpose of design transfer. Ensures conformance to change control requirements for process and production changes. Maintains compliance to FDA Quality System Regulations, ISO:13485 standards and other regulations, as applicable. Performs special assignments and other duties as assigned. Interfaces effectively with senior leadership. Supports internal and external audits/inspections. Prepares and implements facility policies and procedures relating to quality. Ensures alignment and compliance to Corporate, Segment, Business Unit, and Department procedures. Qualifications: Verbal communication skills and presentation skills: Ability to create and understands how to present information dependent upon the level of the audience. Technical writing skills: Creating reports, presentations, rework protocols, validation protocols, metrics, procedures, forms, flowcharts, quality plans, quality agreements, etc., and review and approve technical documentation, as required. Leadership skills: Prioritizing resources based on changing business needs. Budgeting skills: Ability to control costs while providing appropriate resources in order to maintain compliance posture while meeting business needs. Computer skills: Ability to create and manage technical documents, as needed; ability to use electronic communication, time management, ERP and EDMS systems. Knowledge of medical device regulation, industry or international standards. Ability to understand Organization, Corporate, Business Unit, and other Facilities Quality Systems and be able to implement systemic changes to enhance product quality and improve business efficiency. Knowledge and demonstrated use of document control, training and time management practices and investigational techniques (e.g., CAPA, non-conformance, thresholds, fishbone, 5-Whys). Ability to interpret Regulations and Procedures. Extensive knowledge of quality systems and relationship to business, along with inspection, testing, product release, manufacturing processes and associated systems. Fundamental knowledge of validation principles. Understands basic applied statistics, statistical sampling plans, and statistical process control.. Ability to find opportunities for quality and cost improvements. Ability to participate and provide leadership on teams and maintain positive work environment with those teams. Understand team functions, leadership techniques and project management methodologies. Ability to effectively manage time and handle multiple task assignments. Ability to translate quality requirements into product specifications. EDUCATION and/or EXPERIENCE: Bachelor's degree or higher in Science, Engineering, Technology or related field. Minimum of seven (7) years' experience in quality engineering within medical device or pharmaceutical manufacturing. Two (2) plus years' supervisory experience. Class III medical device experience is required. Working knowledge of chemical and molecular processes. Experience with managing FDA audits. Thorough knowledge of regulations governing production, packaging, inspection (preferably incoming/final release), testing and warehousing. ASQ CQE certification preferred. At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit ********************** Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics. #LI-PRO Required Skills Optional Skills . Primary Work LocationUSA CA - Irvine NeomendAdditional LocationsWork Shift At BD, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You. Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles. Salary Range Information $126,600.00 - $208,900.00 USD Annual

Ocular Therapeutix, Inc. (NASDAQ:OCUL) is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology, ELUTYX™. Ocular Therapeutix has built a robust product pipeline of drug delivery solutions developed to reduce the complexity and burden of the current standard of care and position itself to become a leader in the ophthalmic space. Outside of the ophthalmic realm and behind the doors of our headquarters in Bedford, MA, we strive to build a strong culture where employees can flourish and achieve their career goals. We encourage out of the box thinking, cross-functional collaboration, and creativity. I. Position Summary: The Head of Quality Assurance is accountable for overseeing all aspects of Quality Assurance within Ocular Therapeutix. This role involves the planning, development, and execution of QA policies, programs, and initiatives to ensure that all materials, parts, and products meet established quality standards. This role is also accountable for company compliance with all cGMP, GxP, and ICH governmental regulations. The Head of QA will set quality objectives, formulate strategic action plans, and establish audit and surveillance protocols and be accountable for overseeing the Quality Management System (QMS) and monitoring the entire production process to ensure compliance with the applicable regulatory requirements. The Head of QA will provide leadership and guidance to personnel within QA groups and serve to support and liaise with other Functional Areas. This is a critical position within the Quality Leadership Team (QLT) and onsite presence is essential due to the level of cross-functional collaboration that it involves. This position is reporting to the VP, Global Head QA/QC. II. Principal Duties and Responsibilities include the following: Leadership & Strategy: Lead the development and implementation of QA strategies, ensuring alignment of the Organization's goals and regulatory requirements. Set quality objectives and create strategic action plans to achieve desired quality results. Lead, mentor, and develop a high-performing QA team, fostering a culture of excellence, innovation, and continuous improvement. Collaborate with cross-functional leaders to integrate quality considerations into all aspects of product development, manufacturing, and commercialization. Establish/monitor Key Performance Indicators (KPIs) to measure and enhance the effectiveness of Ocular's QMS and the performance of the QA Team. Oversee the development and implementation of quality policies, procedures, and training programs to ensure cGMP compliance and product quality. Provide guidance on quality risk management, change control, and CAPA (Corrective/Preventive Actions) processes. Participate in due diligence activities for potential partnerships, acquisitions, or expansion opportunities, assessing quality implications and integration challenges. Management: Directly manage an excellent team of QA professionals and provide strategic leadership to the QA Team for sustained QMS programs with a continuous focus on improvement. Prepare employee development plans and provide regular performance reviews. Quality Assurance Programs: Accountable for the creation and execution of comprehensive QA policies and programs. Accountable for ensuring all processes, testing protocols, and standards are rigorously followed to maintain product integrity. Participate in CCRB (Change Control Review Board) actions to review and approve all critical change control documents and approve verification and validation protocols and their corresponding final reports. Regulatory Compliance: Stay informed on industry standards and government regulations to ensure all company quality processes meet or exceed these requirements. Work closely with regulatory bodies to maintain compliance and support responses to Health Authorities as needed. Participate in the preparation, review and approval of CMC sections of regulatory filings. Incorporate QbD (Quality by Design) into development activities to ensure successful scale-up and commercialization capabilities. Audit & Surveillance: Provide guidance on quality investigations as needed for all development and commercial products. Accountable for the timely completion of CAPAs to ensure cGMP and GxP compliance. Accountable for the development and direct management of quality investigations of customer complaints, non-conforming materials and processes, CAPAs, and product quality related risk analysis. Accountable for the compliance of third-party suppliers with applicable government regulations. Ensure timely release of clinical and commercial product batches. Establish and direct audit and surveillance protocols to monitor the production process and initiate quality investigations as needed to ensure compliance. Training & Development: Accountable to enhance existing training programs, standards, tools, and methods to cultivate a culture of quality throughout Ocular. Ensure that all team members are adequately trained in applicable procedures. Oversee development of personnel within the Quality Organization. Continuous Improvement: Drive continuous improvement initiatives across all quality processes. Utilize data and analytics to identify areas for enhancement and implement solutions. Reporting & Communication: Serve as the primary point of contact for QA related inquiries. Provide timely and regular reports to Senior Management on product quality status, compliance issues, status of QA programs, quality improvement initiatives, and QMS operational status. III. Qualification Requirements: Bachelor's Degree in Life Sciences or related field. 15+ years of experience in the pharmaceutical industry with prior quality management experience. Experience working in a GxP setting (commercial and/or clinical). Expertise in QMS and compliance. Knowledge of domestic and international regulatory guidelines such as, CFR 210, 211, USP, FDA, ICH, MHRA, EMA, and others. Knowledge of electronic systems. Experience with external regulatory inspections (e.g., FDA). Excellent organizational skills and attention to Strong interpersonal, verbal and written communication Computer literacy, proficiency in MS Office, Excel, PowerPoint Salary Range$250,000-$270,000 USD Ocular Therapeutix is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws regarding nondiscrimination. Ocular Therapeutix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, or status as a veteran. For information on how Ocular Therapeutix collects, stores, and utilizes candidate information please see our privacy policy found at ************************************** For the Privacy Notice for California Job Applicants, please see CCPA Applicant Notice.

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 **************************************.

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 **************************************.

Summary/objective The Engineering and Facilities (E&F) Planning Coordinator works closely with project team members, members of the leadership team and key customers to help deliver major organizational projects and key initiatives efficiently. The E&F Planning Coordinator manages the technical and administrative tasks, such as scheduling, resource forecasting and planning, document and information distribution, report collation and communication support. The E&F Planning Coordinator, Engineering/Facilities provides direct support to the Facilities and Engineering Team. This position is integral to the successful coordination, alignment, and management between the departments/disciplines related to engineering, design, fabrication, building operations (facilities), EH&S, radiation safety and cGMP quality regulations. You are an open minded, committed team player who is able to meet people where they are and utilize communication and tools to masterfully guide them to the goal. Words used to describe you include self-starter, resilient, exhibits patience and grace. You are energized by completing tasks well and on time, enabling teams to reach optimal outcomes. You are someone who lives and breathes keeping things organized and supporting others in being successful. Essential functions Work independently and with members primarily in or related to the engineering/facilities, accelerator, EH&S, radiation safety including but not limited to project leads within the technical teams, and members in the leadership team.. Maintain portfolio of medium complexity projects supporting manufacturing and continuous improvement. Development of templates and standards for electronic project tracking and resource estimation. Masterfully manage up, down, and across the organization to optimize outcomes and proactively contribute to a fun, nurturing, motivating culture. Provide information and regular support to stakeholders. Serve as point of contact for various working groups; Share relevant documentation and reports with project teams. Develop in-depth understanding of project scope and particulars i.e. timeframes, project teams, etc. Schedule project activities for internal team and contractors. Maintain senior leadership and execution level schedules for project success. Understand formal escalation and review processes. Provide support to project managers and business leaders. Thorough project documentation; Creating and reviewing of reports. Positively influence a diverse team of skilled professionals. Within the department and across the organization, foster a culture of respect, safety, quality, and continuous improvement aligning with the mission, vision, and values of the organization. Competencies Excellent communication and interpersonal skills - you know how to develop & maintain strong relationships with all levels/teams of the organization. Models the Niowave Values of Teamwork, Courage, Integrity, and Upright Zeal. Understand how to integrate into a new team/organization - appreciate the history of current state, know how and when to make suggestions, as well as using just the right pace to reach the improved future state. Understand your own communication and learning styles, assess others' styles, and are able to find the right path to connect the two. Exceptional technology skills - you find working with any software very comfortable and you easily adapt to new products; Highly efficient with MS Office products; Expert skill with project tracking such as MS Project and Smartsheet is essential. Extremely attentive to details, particularly with written communications, and PowerPoint presentations. Highly responsive and resourceful. Ability to anticipate needs and use good business judgment in escalating priority issues. Extremely confidential; experienced in handling highly sensitive information discreetly. Accountable, responsible, and able to work independently. Very flexible, able to pivot quickly as priorities change. Professional demeanor; calm, polite, kind, well-spoken. Required education and experience Bachelor's degree in engineering, business, management, or related field or equivalent combination of work experience, certifications and/or degree. 8+ years' experience supporting project teams and providing technical and administrative support to others. Preferred education and experience Formal training/experience in agile project management. Formal training/experience with Scrum and Lean project management framework and tools. Project management certification such as CAPM, PMP, PMI-ACP, or CSM. MS Office certification. Educational or work experience with manufacturing, engineering, information systems. Work Environment This job operates in a professional office environment. This role routinely uses standard office equipment. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is occasionally required to: Stand; walk; sit; stand and sit for prolonged periods Use hands and fingers to handle, or feel objects, tools or controls Vision abilities including near vision/acuity and visual color discrimination Talk and hear Reach with hands and arms Climb stairs Wear safety glasses, goggles, gloves, and Tyvek suit Ability to lift or move products and supplies, up to 25 pounds. Position Type/Expected Hours of Work/Travel Full-time position. Company's standard operating hours are Monday thru Friday 6a - 6p with production related activities requiring 24/7/365 shifts. This position is a part of shift work including nights, weekends, and holidays. Niowave has multiple locations within the Lansing area. Travel between locations is expected in the role. .Other duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

The Quality Assurance Manager, Contract Manufacturers (CMOs) oversees all quality-related activities for external manufacturing partners producing OTC semisolid drug products. This includes compliance with FDA 21 CFR Part 210/211, CHPA guidelines, ICH Q7/Q9/Q10, supplier quality expectations, and internal QMS requirements. Reporting to: Director, Quality Services Location: Johnson City, TN - onsite Responsibilities/Essential Duties: Provide quality oversight of CMOs producing OTC semisolid products. Develop and maintain Quality Agreements. Plan and execute GMP audits; support regulatory inspections. Review batch documentation, deviations, and OOS/OOT investigations. Provide technical QA oversight for semisolid manufacturing processes. Oversee complaint investigations, CAPA management, and effectiveness checks. Evaluate and approve change controls from CMOs. Oversee stability program execution and data review. Manage supplier and material quality, including qualification, requalification, and specification control. Ensure supplier notifications, investigations, and raw material issues are managed per GMP. Support continuous improvement and QMS enhancements. Office-based with travel to CMOs and supplier sites. Ability to wear PPE as required. Basic Qualifications: Bachelor's degree & 5+ years' directly related experience. Preferred Qualifications: Bachelor's degree in scientific or engineering field. 5-10 years' QA experience in pharmaceuticals, OTC, or semisolid manufacturing. Experience managing CMOs and suppliers. Knowledge of FDA 21 CFR 210/211 and ICH Q guidelines. Technical expertise in semisolid manufacturing quality standards. Strong auditing and communication skills. Proficiency with electronic QMS platforms. Company Summary: Crown is a proud member of the Revance Portfolio of skincare offerings. Revance is a fast-growing global aesthetics and skincare company focused on providing innovative aesthetics and market-leading skincare offerings throughout every stage of life. With a differentiated portfolio of products spanning 60 countries, Revance meets the evolving needs of patients and consumers worldwide through continued innovation and commercialization of new products and treatments. What Revance invests in you: Competitive Compensation including base salary and annual performance bonus. Flexible PTO, holidays, and parental leave. Generous healthcare benefits, HSA match, 401k match, employer paid life and disability insurance, pet insurance, wellness discounts and much more! This section of the is required by the American with Disability Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a “qualified individual with a disability” in all aspects of the employment relationship. A “qualified individual with a disability” is “an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job.” Revance is an Equal Opportunity employer. All qualified applicants will receive consideration for employment based on merit, without regard to race, color, religion, sex, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

The Quality Assurance Manager, Contract Manufacturers (CMOs) oversees all quality-related activities for external manufacturing partners producing OTC semisolid drug products. This includes compliance with FDA 21 CFR Part 210/211, CHPA guidelines, ICH Q7/Q9/Q10, supplier quality expectations, and internal QMS requirements. Reporting to: Director, Quality Services Location: Johnson City, TN - onsite Responsibilities/Essential Duties: * Provide quality oversight of CMOs producing OTC semisolid products. * Develop and maintain Quality Agreements. * Plan and execute GMP audits; support regulatory inspections. * Review batch documentation, deviations, and OOS/OOT investigations. * Provide technical QA oversight for semisolid manufacturing processes. * Oversee complaint investigations, CAPA management, and effectiveness checks. * Evaluate and approve change controls from CMOs. * Oversee stability program execution and data review. * Manage supplier and material quality, including qualification, requalification, and specification control. * Ensure supplier notifications, investigations, and raw material issues are managed per GMP. * Support continuous improvement and QMS enhancements. * Office-based with travel to CMOs and supplier sites. * Ability to wear PPE as required. Basic Qualifications: * Bachelor's degree & 5+ years' directly related experience. Preferred Qualifications: * Bachelor's degree in scientific or engineering field. * 5-10 years' QA experience in pharmaceuticals, OTC, or semisolid manufacturing. * Experience managing CMOs and suppliers. * Knowledge of FDA 21 CFR 210/211 and ICH Q guidelines. * Technical expertise in semisolid manufacturing quality standards. * Strong auditing and communication skills. * Proficiency with electronic QMS platforms. Company Summary: Crown is a proud member of the Revance Portfolio of skincare offerings. Revance is a fast-growing global aesthetics and skincare company focused on providing innovative aesthetics and market-leading skincare offerings throughout every stage of life. With a differentiated portfolio of products spanning 60 countries, Revance meets the evolving needs of patients and consumers worldwide through continued innovation and commercialization of new products and treatments. What Revance invests in you: * Competitive Compensation including base salary and annual performance bonus. * Flexible PTO, holidays, and parental leave. * Generous healthcare benefits, HSA match, 401k match, employer paid life and disability insurance, pet insurance, wellness discounts and much more! This section of the is required by the American with Disability Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a "qualified individual with a disability" in all aspects of the employment relationship. A "qualified individual with a disability" is "an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job." Revance is an Equal Opportunity employer. All qualified applicants will receive consideration for employment based on merit, without regard to race, color, religion, sex, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

Join our Quality Operations team and play a key role in ensuring compliance and building strong partnerships with our customers. In this role, you will manage quality-related processes, lead customer meetings, and drive continuous improvement initiatives that support life-changing therapies. What you will get: An agile career and dynamic working culture An inclusive and ethical workplace Competitive compensation programs that recognize high performance Medical, dental, and vision insurance Opportunities for professional growth and development Our full list of global benefits can be found here: ************************************** What you will do: Serve as the primary QA liaison for assigned customers Manage change controls, deviations, investigations, and CAPAs Lead Joint Quality Team meetings and track action items Review and approve quality documents, including agreements and batch records Support customer audits and ensure compliance with data integrity principles Collaborate with internal teams to resolve quality issues Track and present customer metrics and KPIs What we are looking for: Bachelor's degree in a scientific field or equivalent experience 5-10 years in GMP environments and quality assurance Strong understanding of compliance and regulatory requirements Excellent organizational and analytical skills Ability to manage multiple priorities in a dynamic environment Effective communication and relationship-building skills A proactive, detail-oriented mindset with a focus on quality About Lonza At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone's ideas, big or small, have the potential to improve millions of lives, and that's the kind of work we want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you're ready to help turn our customers' breakthrough ideas into viable therapies, we look forward to welcoming you on board. Ready to shape the future of life sciences? Apply now.

Join our Quality Operations team and play a key role in ensuring compliance and building strong partnerships with our customers. In this role, you will manage quality-related processes, lead customer meetings, and drive continuous improvement initiatives that support life-changing therapies. What you will get: An agile career and dynamic working culture An inclusive and ethical workplace Competitive compensation programs that recognize high performance Medical, dental, and vision insurance Opportunities for professional growth and development Our full list of global benefits can be found here: ************************************** What you will do: Serve as the primary QA liaison for assigned customers Manage change controls, deviations, investigations, and CAPAs Lead Joint Quality Team meetings and track action items Review and approve quality documents, including agreements and batch records Support customer audits and ensure compliance with data integrity principles Collaborate with internal teams to resolve quality issues Track and present customer metrics and KPIs What we are looking for: Bachelor's degree in a scientific field or equivalent experience 5-10 years in GMP environments and quality assurance Strong understanding of compliance and regulatory requirements Excellent organizational and analytical skills Ability to manage multiple priorities in a dynamic environment Effective communication and relationship-building skills A proactive, detail-oriented mindset with a focus on quality About Lonza At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone's ideas, big or small, have the potential to improve millions of lives, and that's the kind of work we want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you're ready to help turn our customers' breakthrough ideas into viable therapies, we look forward to welcoming you on board. Ready to shape the future of life sciences? Apply now.

Company Information Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With over 40 years of experience and a growing team of over 2,200 experts servicing global clients from North America and European sites, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing. At Cambrex, our people set us apart. We're committed to attracting, nurturing, and retaining a passionate and talented team of valued experts in our fast-paced and growing company. We offer an exceptional benefits package including medical, dental, vision, Life, LTD, generous vacation in your first year, sick time, and retirement savings! Known for our scientific and manufacturing excellence, as well as our strong customer focus, we offer a range of career opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Job Overview Come join our QC team of experts. This role will manage and direct Quality Control scientific staff. Focus efforts of self and team on analytical support with analytical activities involving the stability and reference standard programs. Enhance efficiency of current systems. Mentor and develop team members. Seek innovative cost and scientific solutions. Ensure compliance with applicable Company SOPs and regulatory guidelines. Responsibilities Manage/coordinate/drive efforts of staff in stability plan design and coordinating the activities that support the entire stability lifecycle of the study. Manage/coordinate/drive efforts of staff in the design of stability protocols and reports in accordance with ICH guidelines and publishing in MasterControl with adherence to associated SOPs. Manage/coordinate stability study set down to fraction and stage materials. Track/monitor all active stability programs including pull dates and report issue dates. Ensure stability inventory is correct and up to date. Manage/coordinate/drive efforts for reference standard management and retesting program. Track/monitor all current reference standards to plan for the testing and timely delivery of certificates. Provide training/development for specified laboratory staff on the stability and reference standard program. Routinely represents the department on stability and reference standard topics in internal or external meetings, with clients, and during audits. Assure compliant, staffed analytical laboratory support. Write deviations, assist/lead laboratory investigations, and assist in CAPAs relative to stability and reference standard program. Recommend/justify new/additional equipment, staffing or organizational positions, promotions. Qualifications/Skills Excellent verbal and written communication and interpersonal skills, problem-solving, and organizational skills. Track record of successfully applying high level judgment in a variety of complex and unprecedented situations. Proven ability to act independently to achieve pre-determined goals and objectives and obtain desired results. Ability to coach and develop staff and to transfer job knowledge and skills. Ability to integrate input/data from diverse sources and create new and innovative solutions. Demonstrated ability to apply technical, functional, and industry knowledge to design and execute projects that shape the strategic direction of one or more projects. Other demonstrated abilities: work in a diverse team environment; foresight and judgment in planning, organizing, and guiding complex projects; making complex decisions and troubleshooting in ambiguous situations. Exposure to broader analytical techniques (i. e. , beyond just USP compendial testing). Education, Experience & Licensing Requirements BS, MS, or PhD in Chemistry (or closely related discipline). A minimum of at least 7 plus years' experience in QC (or similar role) with 2 plus years' experience managing others in a laboratory environment (prefer in a GMP/QC-compliant pharmaceutical laboratory environment) with focus on ICH stability testing. Strong Quality Control, compliance, scheduling, and organizational skills and insight. Expertise in most common analytical techniques/technologies (e. g. , HPLC, GC, LC/GC/MS, IR, Empower, etc). Expertise in USP compendial and other technical application testing and in OOS investigations. Expertise in creating and interpreting SOPs. Ability to function as technical expert/consultant. Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. #LI-RD1 Sedentary work, exerting up to 10 pounds of force occasionally, and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects. The daily work is performed in an office setting and involves sitting most of the time. Walking and standing are required only occasionally. Knowledge of working with hazardous chemicals. Position also requires visual acuity, talking, writing, and typing. BS, MS, or PhD in Chemistry (or closely related discipline). A minimum of at least 7 plus years' experience in QC (or similar role) with 2 plus years' experience managing others in a laboratory environment (prefer in a GMP/QC-compliant pharmaceutical laboratory environment) with focus on ICH stability testing. Strong Quality Control, compliance, scheduling, and organizational skills and insight. Expertise in most common analytical techniques/technologies (e. g. , HPLC, GC, LC/GC/MS, IR, Empower, etc). Expertise in USP compendial and other technical application testing and in OOS investigations. Expertise in creating and interpreting SOPs. Ability to function as technical expert/consultant. Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. #LI-RD1Manage/coordinate/drive efforts of staff in stability plan design and coordinating the activities that support the entire stability lifecycle of the study. Manage/coordinate/drive efforts of staff in the design of stability protocols and reports in accordance with ICH guidelines and publishing in MasterControl with adherence to associated SOPs. Manage/coordinate stability study set down to fraction and stage materials. Track/monitor all active stability programs including pull dates and report issue dates. Ensure stability inventory is correct and up to date. Manage/coordinate/drive efforts for reference standard management and retesting program. Track/monitor all current reference standards to plan for the testing and timely delivery of certificates. Provide training/development for specified laboratory staff on the stability and reference standard program. Routinely represents the department on stability and reference standard topics in internal or external meetings, with clients, and during audits. Assure compliant, staffed analytical laboratory support. Write deviations, assist/lead laboratory investigations, and assist in CAPAs relative to stability and reference standard program. Recommend/justify new/additional equipment, staffing or organizational positions, promotions.

Why Us? At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day. Summary The Chemist I, under direct supervision, learns and performs QC laboratory chemical analyses of raw materials, in-process materials, stability & finished products, and testing to support process validation. May participate in investigations. Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing. Job Description Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc. Typically supports one Par business, at a single site Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time Accountability Responsibilities % of Time Analysis & Testing * Conducts routine laboratory analyses: finished product testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing. Typical activities may include buffer/solution preparation, standard preparation and operating analytical instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. * Uses laboratory software for analyses 65% Lab Equipment * Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping * Cleans lab working surfaces and disposes of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals * Under close supervision, learns to troubleshoot basic instrument problems 20% Investigations * With guidance, participates in OOS/OOT/NOE and other investigations * Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor * May assist in drafting, editing, and reviewing SOPs and laboratory investigations 10% Training * Maintains assigned training records current and in-compliance * May assist in the training of less senior laboratory staff 5% Compliance * Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting * Document accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs * Follows internal processes related to controlled substances continuous Safety * Follows EH&S procedures to ensure a safe work environment * Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS continuous Total 100% Qualifications Education & Experience Minimal acceptable level of education, work experience and certifications required for the job * Bachelor of Science Degree in chemistry, chemical engineering or related field with analytical chemistry coursework required. * Some pharmaceutical laboratory experience preferred. Knowledge Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc. * Proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. * Basic knowledge of wet chemistry techniques * Knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS * Competency in Microsoft Office Suite Skills & Abilities Often referred to as "competencies", leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc. * Ability to display and analyze data in a logical manner * Good verbal and written communication skills as well as good computer skills * Attention to details and accurate record keeping * Establish and maintain cooperative working relationships with others * Solid organizational skills * Ability to take initiative, set priorities and follow through on assignments Physical Requirements Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc. * Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals * Must occasionally lift and/or move up to 15-25 lbs. * Ability to wear personal protective equipment, including respirators, gloves, etc. * Specific visions abilities are required by this job include close vision and color vision * Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Why Us? At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day. Summary The Chemist I, under direct supervision, learns and performs QC laboratory chemical analyses of raw materials, in-process materials, stability & finished products, and testing to support process validation. May participate in investigations. Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing. Job Description Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc. Typically supports one Par business, at a single site Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time Accountability Responsibilities % of Time Analysis & Testing Conducts routine laboratory analyses: finished product testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing. Typical activities may include buffer/solution preparation, standard preparation and operating analytical instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Uses laboratory software for analyses 65% Lab Equipment Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping Cleans lab working surfaces and disposes of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals Under close supervision, learns to troubleshoot basic instrument problems 20% Investigations With guidance, participates in OOS/OOT/NOE and other investigations Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor May assist in drafting, editing, and reviewing SOPs and laboratory investigations 10% Training Maintains assigned training records current and in-compliance May assist in the training of less senior laboratory staff 5% Compliance Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting Document accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs Follows internal processes related to controlled substances continuous Safety Follows EH&S procedures to ensure a safe work environment Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS continuous Total 100% Qualifications Education & Experience Minimal acceptable level of education, work experience and certifications required for the job Bachelor of Science Degree in chemistry, chemical engineering or related field with analytical chemistry coursework required. Some pharmaceutical laboratory experience preferred. Knowledge Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc. Proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Basic knowledge of wet chemistry techniques Knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS Competency in Microsoft Office Suite Skills & Abilities Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc. Ability to display and analyze data in a logical manner Good verbal and written communication skills as well as good computer skills Attention to details and accurate record keeping Establish and maintain cooperative working relationships with others Solid organizational skills Ability to take initiative, set priorities and follow through on assignments Physical Requirements Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc. Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals Must occasionally lift and/or move up to 15-25 lbs. Ability to wear personal protective equipment, including respirators, gloves, etc. Specific visions abilities are required by this job include close vision and color vision Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.