Manager Quality Assurance Validation

Regeneron Pharmaceuticals • Saratoga Springs, UT

1d • $92,200 - $176,000 • Onsite

About The Position

Regeneron is hiring a Manager Quality Assurance (QA) Validation for its new highly automated drug substance manufacturing facility in Saratoga Springs. The position leads the laboratory and analytical equipment validation function, including qualification of laboratory and analytical instrumentation supporting quality control and manufacturing science. It also provides secondary oversight of manufacturing equipment and utility qualification, as well as cleaning and sterilization validation. The manager participates in and defends validation data during FDA and other regulatory inspections.

The role develops policies and qualification strategies, oversees validation documentation and systems, manages budgets, contracts, schedules, and QA Validation resources, and works with site Quality Control, Manufacturing Science, QA Validation, and Computer Systems Assurance leadership. It also supports hiring and separation activities and counsels employees on performance. The initial location is Rensselaer, New York, with a permanent location in Saratoga Springs, New York. The work model is Monday through Friday, 8:00 a.m. to 4:30 p.m.; occasional on-call or weekend flexibility may be requested. The role requires full cleanroom attire and the ability to perform physical requirements throughout a shift of up to 10 hours in a cleanroom environment.

Requirements

• BS/BA in engineering, chemistry, life sciences, or a related field, or an equivalent combination of education and experience.
• At least 7 years of experience for the Manager QA Validation level; the posting also lists an Associate Manager QA Validation level requiring at least 6 years of experience. Level will be determined based on experience.
• Previous people leadership or supervisory experience.
• Experience qualifying laboratory and analytical instrumentation, such as HPLC, GC, balances, and spectrophotometers, in a GMP QC or manufacturing science environment.
• Ability to wear full cleanroom attire and remove jewelry, makeup, and nail adornments while wearing it.
• Ability to perform physical requirements for the entirety of a shift of up to 10 hours in a cleanroom environment, including activities such as bending, climbing, crawling, kneeling, reaching, sitting, squatting, walking, standing, driving, hand manipulation, and lifting, pushing, or pulling up to 50 pounds.

Nice To Haves

• Experience validating equipment and utilities in a highly automated or greenfield manufacturing environment.

Responsibilities

• Design and develop policies for laboratory and analytical equipment qualification and validation, and secondarily for manufacturing equipment, utilities, and process validation, ensuring effective administration and regulatory compliance.
• Oversee all aspects of QA laboratory equipment validation, including review and approval of failure investigations, change controls, test plan documentation, SOPs, qualification protocols and summary reports, and relevant Validation Master Plan content.
• Lead qualification strategy for laboratory and analytical instrumentation, including HPLC, GC, spectrophotometers, balances, incubators, and software-integrated analytical systems supporting QC, manufacturing science, and release testing.
• Provide secondary oversight of manufacturing equipment and utility qualification and cleaning and sterilization validation programs.
• Develop and manage validation budgets, contracts, and schedules.
• Present and defend validation data to the FDA and other regulatory agencies.
• Maintain the validation document and software control system for laboratory equipment and instrumentation qualification records.
• Ensure the validated state is maintained for laboratory, analytical, and manufacturing equipment used in commercial and clinical operations.
• Organize QA Validation resources assigned to functional areas to meet goals and timelines, and coordinate activity prioritization with laboratory and manufacturing area management.
• Partner with the Director, QA Validation & Computer Systems Assurance, and Quality Control and Manufacturing Science leadership to align laboratory equipment qualification strategy with the site's CSA and automation qualification programs.
• Develop and apply new approaches and processes for laboratory and equipment validation strategies in a highly automated facility.
• Counsel employees on work performance and conduct hiring and separation activities.

Benefits

• Annual bonuses or other incentive plans may be offered, depending on country and role.
• Equity awards may be offered, depending on country and role.
• Pension or retirement benefits may be offered, depending on country and role.
• 401(k) company match may be offered, depending on country and role.
• Health and wellness programs may be offered, depending on country and role.
• Fitness centers may be available, depending on country and role.
• Insurance benefits may include medical, dental, vision, life, and disability coverage, depending on country and role.
• Paid time off may be offered, depending on country and role.
• Family support benefits may be offered, depending on country and role.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager