Bristol-Myers Squibb Company

Head Of Pharmaceutical Quality Internal Sites

New Brunswick, NJ, US
Apr 17, 2018
Required Education
Position Type
Full time
The Head Of Pharmaceutical Quality Internal sites reports directly to the Vice President, Key Brands Manufacturing Quality, with job responsibilities that include but are not limited to:
  • Provides quality leadership to internal manufacturing plants in the region (Aichi, Minhang, Humacao, Agen and Anagni). Owns responsibility for all regulatory and compliance activities within the region and leads a quality organization of ~500-600 employees.
  • Creates and maintains a high level of commitment to quality and compliance. Understands the regulatory environment and works proactively to assure that the state of the industry is anticipated and maintained.
  • Fulfills Quality Unit responsibilities described in BMS-Corporate Policies and GMS Policies and Directives.
  • Communicates effectively and builds cooperative and supportive working relationships with all GMS sites in the supply chain on technical, and quality matters. Interfaces with members of the GMS Management Team.
  • Maintains positive relationships inside and outside of the Company, including regulatory agencies and BMS business partners and suppliers. Proven ability to lead and motivate employees in all operational areas of the Company.
  • Leads and develops staff to achieve professional growth and attain established goals and a robust succession plan. Develop remedial action for staff whose performance does not meet standards.

  • Manages through direct report the Quality and Compliance functions at Aichi, Minhang, Humacao, Agen and Anagni.
  • Develops/revises policies and directives.
  • Approves methods and specifications for pharmaceutical products.
  • Implements policies and procedures consistent with regulatory compliance. Ensures adherence to QC/QA procedures, policies and guidelines.
  • Implements systematic corrective action. Anticipates regulatory trends and establishes systems to minimize GMP compliance impact to each site and the Company.
  • Leads fact finding during investigations.
  • Maintains oversight of departmental spending. Reviews budget and conduct oversight of periodic projections of spending against budgets. Determines merit salary actions for staff.
  • Participates and contributes to site Quality Councils and BMS governing Quality Council to ensure that management with executive responsibility are appropriately informed and aware of the suitability and effectiveness of the quality system and significant events.
  • Approves the Quality Plan for each site and subsequent revisions as required.
  • Ensures that sites are inspection-ready at all times and attend site inspections as required.

***This position will be located in New Brunswick (NJ, USA)***