Manager Quality Assurance Validation

Discover your role:

• 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 and associated test plan documentation, SOPs, qualification protocols and 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

The environment and physical rhythms of the role:

• Gowning: Full cleanroom attire (Examples may include: including 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
• Ability to perform physical requirements for entirety of shift (up to 10 hours) in a clean room environment
• Some physical requirements can include but not limited to: bending, climbing, crawling, kneeling, reaching, reaching overhead, sitting, squatting, walking, standing, driving, hand manipulation and ability to lift/push/pull up to 50lbs