Manager Quality Assurance, Compliance

About the role

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.

Responsibilities

• 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 Requirements Of The Role

• Full cleanroom attire (Examples may include: 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

Requirements

This Role Requires BS/BA in Life Sciences or related field; or equivalent combination of education and experience

• Associate Manager Quality Compliance: 6+ years of relevant experience
• Manager Quality Compliance: 7+ years of relevant experience
• Sr. Manager Quality Compliance: 8+ years of relevant experience
• Level will be determined based on experience
• Experience with drug product manufacturing and/or fill finish

Pay

Salary Range (annually): $92,200.00 - $176,000.00