Job Description
**Regeneron Sr QA Validation Specialist** **Provide technical leadership and mentorship for qualification activities and data integrity initiatives in a highly regulated environment.** Within this role, you will be responsible for providing technical leadership and mentorship for qualification activities and data integrity initiatives in regard to small manufacturing and laboratory equipment (e.g. HPLC/UPLC, TOC analyser, FTIR, microscopes) in the frame of Industrial Operations and Product Supply of biological products in accordance with cGxP, regulatory requirements and industry trends. **Key Responsibilities:** • Supervise the end-to-end qualification process to ensure each piece of equipment fits for the intended use that contributes to 365 inspection readiness program • Foster and implement a quality culture and company manufacturing standards, policies and procedures • Schedule, execute, review and approve qualification activities • Assess executed change controls and deviations for impact to the qualified state for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria • Investigate and troubleshoot problems which occur and determine solutions or recommendations for changes and/or improvements • Review, edit, and approve deviation notifications, deviation investigations and corrective actions • Review, edit, and approve change controls, SOPs, reports and other documentation • Coordinate with other departments and outside contractors/vendors to complete validation tasks • Collaborate with functional departments to resolve issues • Manage and drive projects • Prepare, review and approve status reports • Supervise, provide direction and assign work to less experienced full-time employees (e.g. validation specialists) and/or contingent workers to meet goals and deadlines • Stay current with industry trends, regulatory requirement updates and communicate the same to a team • Travel may be required **Requirements:** • Expert knowledge of EU annex 11 and FDA 21 CFR Part 11 • Strong knowledge and understanding of the equipment used for QC analysis and operations • Strong background and familiarity with site change control, risk management and data integrity initiatives/programs • Strong knowledge of Data Integrity • Previous experience as a SME in a highly regulated environment (e.g. pharma, biotech, medical devices) in both internal and external regulatory audits • Ability to prioritize and handle multiple tasks simultaneously • Project management experience **Preferred Qualifications:** • BS/BA in Engineering, Chemistry or Life Sciences with 5+ years of related experience within the field **Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.**