Join a team! We are a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals. Our 7,000 employees share a common goal and values, propelling us to provide essential care to millions of people globally. We seek dedicated individuals who share our sense of urgency, unity, and excellence. We are looking for a trustworthy and respectful individual who consistently does the right thing. Someone who is imaginative and proactive, with a keen eye for what is possible. A perceptive and adaptive person who is action oriented. We need a disciplined, focused, and accountable team member. If you embody these values, come join our company and help us shape the future. We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates it—where your skills and values drive our collective progress and impact. We are seeking an experienced Senior Supplier Quality Specialist who will be responsible for maintaining quality systems and compliance for externally manufactured products and processes throughout the product lifecycle for NDA, ANDA, OTC, Medical Devices, and Combination products. Additionally, The Senior Quality specialist is responsible for managing Annual Product Review (APR) program and Continuous Process Verification (CPV) program. The incumbent will interact with External Manufacturing suppliers and internal business stakeholders, involving Pharmaceutical, Biologics, OTC, Consumer products and Medical Devices, and provide support to commercialized products. This is a hybrid position (3 days onsite) at the US, Bridgewater, New Jersey office location. **RESPONSIBILITIES** + Responsible for managing the Annual Product Review (APR) program end-to-end process which includes but not limited to the preparation of Annual product Review schedule, notification to CMOs to obtain APR reports, review of reports, authoring APR and identifying trends + Develop and enhance a robust Quality system encompassing Annual Product Review and Continuous Process Verification + Review the CMO APR reports, identify any atypical trends and escalate to the cross-functional stake holders. Prepare and present escalated events data to the management + Initiate Quality records in Quality Management systems such as Quality Events, Out of Specifications, CAPA, Change Controls etc. + Responsible for managing CPV Program in accordance with current regulations and the Bausch Health procedures + Archival of the APR and CPV reports in the Electronic Document Management system + As a part of the APR program this position is also responsible for review of the stability reports and analyze the data and trends. Support the stability program management as required. + Support Quality Metrics data collection and present the data in Quality Review Board + Author and/or review of Quality Management SOPs and Specifications in the electronic document management system + Assist quality management in all audits (FDA, Supplier Audits, other Regulatory agencies) + Support other departmental activities as assigned **Qualifications/Competencies:** + Bachelor’s degree required, preferably in pharmaceutical discipline or technical field + 3+ years of experience in pharmaceutical/biological manufacturing, packaging, and laboratory operations + Hands on experience in Quality Assurance activities, including but not limited to review of Batch records, APRs, Investigations, and other Quality Management systems + Working knowledge in management of Stability program and data interpretation is preferred + Demonstrated strong written and oral communication, as well as interpersonal skills + Working knowledge of FDA regulations (21 CFR Part 11, 210, 211, 820) and cGMP is required + Training and experience in the application of problem-solving tools and statistical techniques/software Benefits package includes a Comprehensive Medical (includes Prescription Drug), Dental, Vision, Health Savings Account with company contribution, Flexible Spending Accounts, 401(k) matching, discretionary time off, paid sick time, tuition reimbursement, parental leave, short-term disability, long-term disability, life insurance, accidental death & dismemberment insurance, paid holidays, Employee Assistance Plan, commuter benefit, recognition awards, voluntary benefits (including Identity Theft, Student Loan and Breast Milk Shipping), employee referral bonuses and employee discounts. \#LI-hybrid **This position may be available in the following location(s): [[location_obj]]** Bausch Health Companies Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment regardless of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration. If a candidate needs a reasonable accommodation/adjustment due to physical or mental health impairment for any part of the application process, they are encouraged to send their request to humanresources@bauschhealth.com or call 908-927-1400 and let us know the nature of the request and their contact information. Please be sure to include the job requisition number. Job Applicants should be aware of job offer scams perpetrated through the Internet and social media platforms. To learn more please read Bausch Health's Job Offer Fraud Statement (https://protection.greathorn.com/services/v2/lookupUrl/c29afa19-107c-4ce0-9f8c-cdaacd1f6318/176/af4e247fc99befe729755d44229317a5dc5e5807) . Bausch Health is an EEO/AA employer M/F/D/V.