Manager, Quality Assurance Compliance at Regeneron

Manager Quality Compliance

Regeneron is currently seeking a Manager Quality Compliance to join our Quality Assurance (QA) team. This role is responsible for managing the compliance, audit, training and operations team for the internal fill finish site. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Location: Rensselaer, New York, United States

Work model: Monday-Friday, 8am-4:30pm

Discover your role:

• Lead and develop the QA compliance team: set work plans and objectives, prioritize and assign tasks, coach performance, and manage hiring and separations while aligning deliverables with company goals
• Partner with Managers and Directors to communicate compliance status, audit readiness, and training initiatives, and provide concise, actionable project reporting
• Oversee the lifecycle of quality records (Notices of Event, Change Controls, CAPAs): track, report, and drive timely closure
• Drive audit readiness and execution: align QA practices with requirements, run the audit-ready-365 program, plan and track coaching, and support internal and regulatory audits, including coordinating requests for the internal fill-finish team
• Promote cross-site continuous improvement by collaboratively identifying gaps and sharing best practices
• Shape governance by influencing local and global policies, procedures, and business processes to align with industry standards and best practices
• Stay current on industry trends and regulatory updates and translate insights into changes and improvements

The environment and physical rhythms of the role:

• Gowning: Full cleanroom attire (Examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)
• Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire

This role requires:

• BS/BA in Life Sciences or related field; or equivalent combination of education and experience
• Experience with drug product manufacturing and/or fill finish

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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.