Bristol-Myers Squibb Company

QA Manager - Manufacturing Support

New Brunswick, NJ, US
Sep 09, 2018
Required Education
Bachelors Degree
Position Type
Full time
Scope of the role
  • Provide Quality oversight during Clinical Supply Operations drug product and packaging and labeling manufacturing activities, and other GMP support areas.
  • Provide Quality on the floor in-Process support during manufacturing operations.
  • Assure the quality of manufactured products complies with all applicable regulations and guidelines.
  • Performs monitoring and assessment of the Clinical Supply Operations areas to ensure compliance with all principle of current Good Manufacturing Practices (cGMP).

Key responsibilities
  • Perform monitoring/walkthroughs of GMP areas documenting observations and areas of concern to support inspection readiness of the manufacturing facility and support areas. Supports return to service walkthroughs and Manufacturing inspection readiness walkthroughs.
  • Perform documented periodic assessment of Clinical Supply Operations for Global Audit and Regulatory Agency inspection readiness.
  • Develop and manage responsibilities for the In-process Control QC/QA activities conducted during manufacturing activities (e.g. Line Clearance, AQL inspections).
  • Monitors and trends observations and CAPAs to ensure compliance with cGMP regulations and BMS procedures.
  • Provides instruction and guidance on quality issues and serves as a resource for the site.
  • Supports site operations during regulatory agency and third party inspections.

Professional experience and qualifications
  • Knowledge of science generally attained through studies resulting in B.S. or M.S. in chemistry, pharmacy or biology or a related pharmaceutical science
  • Minimum of 9-11 years experience in pharmaceutical quality and/or operations at a site level, including 3-5 years experience in a regulated function.
  • Experience within a QA/QC environment is an asset
  • Broad experience in the manufacturing of sterile and non-sterile products
  • In-depth knowledge of GMP regulations
  • Strong problem solving, interpersonal and organizational skills
  • Strong collaborative and influencing skills
  • Effective written and verbal communication
  • Computer literacy: Microsoft Office and SAP environment Trackwise┬«, PDLIMs, and other systems as required (eg DeltaV, Pilotclean)