Manager Quality Assurance Validation

About the Role

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We're hiring a Manager Quality Assurance (QA) Validation to join our team at our new highly automated drug substance manufacturing facility in Saratoga Springs. This position leads the laboratory and analytical equipment validation function, ensuring qualification of laboratory and analytical instrumentation supporting quality control (QC) and manufacturing science functions, with secondary oversight of manufacturing equipment, utility qualification, and cleaning/sterilization validation processes.

Responsibilities

• Designs and develops policies related to laboratory and analytical equipment qualification and validation, and secondarily to manufacturing equipment, utility, and process validation, ensuring effective administration and regulatory compliance.
• Responsible for all aspects of QA laboratory equipment validation, including review and approval of failure investigations, change controls, test plan documentation, SOPs, qualification protocols, summary reports, and relevant Validation Master Plan content.
• Leads qualification strategy for laboratory and analytical instrumentation (e.g., HPLC, GC, spectrophotometers, balances, incubators, and software-integrated analytical systems) supporting QC, manufacturing science, and release testing.
• Provides secondary oversight of manufacturing equipment and utility qualification and cleaning/sterilization validation programs.
• Develops and manages validation budget, contracts, and schedules.
• Presents and defends validation data to FDA and other regulatory agencies.
• Maintains the validation document and software control system for laboratory equipment and instrumentation qualification records.
• Ensures validated state is maintained for laboratory, analytical, and manufacturing equipment used in commercial and clinical operations.
• Organizes QA Validation resources assigned to functional areas to meet goals and timelines; coordinates prioritization of activities with laboratory and manufacturing area management.
• Partners with the Director, QA Validation & Computer Systems Assurance, and with Quality Control/Manufacturing Science leadership to align laboratory equipment qualification strategy with the site's CSA and automation qualification programs.
• Plays a proactive role in developing and applying new approaches and processes to laboratory and equipment validation strategies for a highly automated facility.
• Counsels employees on work performance; conducts hiring and separation activities.

Work Environment and Physical Requirements

• Gowning: Full cleanroom attire, including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes, booties, latex gloves, and use of sanitizing agents during gowning process.
• Ability to remove jewelry, make-up, and nail adornments when wearing cleanroom attire.
• Ability to perform physical requirements for the entirety of shift (up to 10 hours) in a cleanroom environment, including bending, climbing, crawling, kneeling, reaching, sitting, squatting, walking, standing, driving, hand manipulation, and lifting/pushing/pulling up to 50 lbs.

Location and Schedule

Initial Location: Rensselaer, New York, United States
Permanent Location: Saratoga Springs, New York, United States
Work Model: Monday-Friday, 8am-4:30pm
Other Requirements: Occasional flexibility may be requested for on-call schedule/weekend work.

Qualifications

• BS/BA in Engineering, Chemistry, Life Sciences, or a related field; or equivalent combination of education and experience.
• Associate Manager QA Validation: 6+ years of experience.
• Manager QA Validation: 7+ years of experience. Level will be determined based on experience.
• Previous people leadership/supervisory experience.
• Experience qualifying laboratory and analytical instrumentation (e.g., HPLC, GC, balances, spectrophotometers) in a GMP QC or manufacturing science environment.
• Experience validating equipment and utilities in a highly automated or greenfield manufacturing environment is preferred.

Pay

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