QA Validation Manager – Lead Lab Equipment & GMP Compliance

Regeneron Pharmaceuticals; Saratoga Springs (UT); Sur place; USD 92 000 - 176 000; Plein temps

Résumé du poste

Regeneron Pharmaceuticals in Saratoga Springs, NY is seeking a Manager QA Validation to lead the laboratory and analytical equipment qualification function. You will oversee validation strategies for laboratory instrumentation and manufacturing utilities, ensuring regulatory readiness and robust data during inspections.

The role requires 7+ years in QA validation with leadership experience, and hands-on qualification of analytical systems (HPLC, GC, spectrophotometers) in GMP settings.

Qualifications

• BS/BA in Engineering, chemistry or life sciences or a related field; or equivalent combination of education and experience.
• 6+ years of experience for Associate Manager QA Validation or 7+ years for Manager QA Validation.
• Experience qualifying laboratory and analytical instrumentation (e.g., HPLC, GC, balances, spectrophotometers) in a GMP QC or manufacturing science environment.
• Previous people leadership/supervisory experience.

Responsabilités

• Designs and develops policies related to laboratory and analytical equipment qualification and validation, ensuring regulatory compliance.
• Lead QA laboratory equipment validation, including review and approval of failure investigations, change controls and SOPs, qualification protocols and summary reports.
• Leads qualification strategy for laboratory and analytical instrumentation (HPLC, GC, spectrophotometers) 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.

Connaissances

Leadership experience

Regulatory inspections experience

Cross-functional collaboration

Formation

BS/BA in Engineering, chemistry or life sciences or a related field

Outils

HPLC

GC

Balances

Spectrophotometers

Description du poste

Regeneron Pharmaceuticals in Saratoga Springs, NY is seeking a Manager QA Validation to lead the laboratory and analytical equipment qualification function. You will oversee validation strategies for laboratory instrumentation and manufacturing utilities, ensuring regulatory readiness and robust data during inspections.

The role requires 7+ years in QA validation with leadership experience, and hands-on qualification of analytical systems (HPLC, GC, spectrophotometers) in GMP settings.