Sr Manager QA Technical Operations
Bristol Myers Squibb · Devens, MA
The apply link worked recently (not employer-confirmed).
Role summary
This senior manager leads a quality assurance team overseeing cell banking, change controls, technology transfer, automation validation, and site maintenance programs at a pharmaceutical manufacturing facility. Responsibilities include supervising quality personnel, managing technical transfer documentation approvals, coordinating with cross-functional stakeholders, and supporting regulatory audits and inspections.
What they're looking for
- Bachelor's degree in science, engineering, or related discipline
- Minimum 5 years biopharmaceutical quality experience with 2-3 years increasing responsibility
- Demonstrated track record leading teams with diverse responsibilities
- Knowledge of US and EU cGMP regulations and FDA/EMA regulatory authority
- Experience with biotech bulk and finished product manufacturing and analytical testing
- Proficiency in business systems including SAP, LIMS, Maximo, Syncade, DeltaV, Veeva Vault
- Strong written and oral communication skills with ability to influence cross-functional stakeholders
What you'll be doing
- Provide direct supervision of quality managers overseeing change controls, protocols, investigations, and validation activities
- Manage operations for cell banking, site change controls, technology transfer, automation, validation, and maintenance programs
- Interface with clinical and commercial technology transfer meetings to coordinate quality approval of technical documentation
- Oversee quality approval of manufacturing maintenance, calibration, and preventive maintenance scheduling programs
- Prepare for and support regulatory and customer audits, including participation in internal audits and health authority inspections
Privacy & handoff
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