Manager Quality Assurance Validation

Regeneron Pharmaceuticals • Saratoga Springs, NY

4d • Onsite

About The Position

Regeneron is hiring a Manager Quality Assurance (QA) Validation for its highly automated drug substance manufacturing facility. The role leads the laboratory and analytical equipment validation function, including qualification of laboratory and analytical instruments supporting Quality Control (QC) and Manufacturing Science. It also provides secondary oversight of manufacturing equipment and utility qualification, as well as cleaning and sterilization validation. The position participates in and defends validation data during FDA and other regulatory inspections.

The initial work location is Rensselaer, New York, with a permanent location in Saratoga Springs, New York. The stated schedule is Monday through Friday, 8:00 a.m. to 4:30 p.m.; occasional flexibility may be requested for on-call scheduling or weekend work. The role requires work in a cleanroom while wearing full cleanroom attire and meeting the physical requirements described in the posting.

The level will be determined based on experience. Regeneron describes a competitive and comprehensive total rewards package that may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, a 401(k) company match, health and wellness programs, fitness centers, insurance benefits, paid time off, and family support benefits. Availability may depend on country and role.

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 a separate Associate Manager QA Validation level requiring at least 6 years; 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.

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.
• Oversee QA laboratory equipment validation, including review and approval of failure investigations, change controls, associated test plan documentation, SOPs, qualification protocols and summary reports, and relevant Validation Master Plan content.
• Lead the qualification strategy for laboratory and analytical instrumentation 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 site CSA and automation qualification programs.
• Develop and apply new approaches and processes to laboratory and equipment validation strategies for a highly automated facility.
• Counsel employees on work performance and conduct hiring and separation activities.

Benefits

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

What This Job Offers

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