Title: Associate Director, Quality Assurance - Operations
Location: Bedford, NH (1 hour from downtown Boston)
Type: Full time, permanent
This role will work with other departments to ensure the quality of products and compliance to internal procedures and external standards. The role supports and provides quality oversight of the day to day operations of the drug manufacturing/testing facilities.
JOB DUTIES -
- Provides quality oversight of manufacturing activities on a day-to-day basis
- Review, develop, and improve quality system procedures, specifications, and test methods
- Provide status reports, including relevant quality metrics and participates in the management review process
- Establish collaborative relationships with internal and external customers to ensure all quality and compliance matters and any issues that arise are addressed in an open and timely manner
- Monitor, identify and propose quality process/system improvements and provides strategic foresight to identify and implement changes to enhance long term goals of the department and drive continuous improvement
- Serve as QA representative to cross functional project teams such as tech transfer, process validation, and process improvement
EXPERIENCE -
- A minimum of 8+ years of overall experience in biopharmaceutical quality
- Knowledge of biotech bulk and finished product manufacturing, Drug Substance or Drug Product batch disposition and batch record documentation experience is highly desirable
- Experience performing RCA, technical writing, and working with quality related investigations
- Knowledge of laboratory and production equipment and IQ/OQ/PQ
- Knowledge of US and EU cGMP regulations and guidance
- Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9
