Bristol-Myers Squibb Company

MANAGER, QUALITY SYSTEMS & COMPLIANCE

Location
Devens, MA, US
Posted
May 12, 2018
Ref
R1505158
Required Education
Bachelors Degree
Position Type
Full time
Summary:

To maintain Internal Compliance activities at the Devens site. This includes program ownership of self-inspection, change control and site compliance with BMS corporate policies and directives (P&D) as well as management of Health Authority requests.

Responsibilities:
  • Owns the self-inspection (i.e. internal audit) program at the site - including management of procedures, development of risk-based inspection schedule, execution of inspections and management of response development and remediation.
  • Track commitments to completion and trends themes accordingly.
  • Owns the site change control program - including management of procedures, oversight of key performance indicators for high quality changes and on-time delivery.
  • Owns the Annual Product Quality Review (APQR) program at the site - including coordination of individual sections for APQR reports (Manufacturing, testing, quality systems, etc.).
  • Ensures site compliance with BMS corporate policies and directives.
  • Documents impact assessments and track commitments to completion.
  • Escalates site compliance issues accordingly. Participates as a core team member in any corporate or regulatory agency inspections and lead cross functional teams to develop responses, tracking the commitments to completion.
  • Maintains Site Master File and serves as key point of contact (POC) with CMC Regulatory group to respond to pre- and post-filing requests for site based information, includes extensive communication and coordination to fill a variety of requests.
  • Leads site inspection readiness activities by conducting readiness assessments against the relevant HA requirements, benchmarking with prior network and industry experience, and maintaining relevant training (may include mock inspections with SMEs).
  • Maintains the inspections logistics program including administration of audit request/near miss system.
  • Hires, trains, and develops qualified Quality Compliance specialist and ensures personnel has adequate training, education and experience to perform their GMP related job function effectively.
  • Maintains resource model for core responsibilities.


Knowledge and Skills:
  • Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is preferred.
  • A minimum of 8 years of relevant experience including 4 years of GMP Quality experience.
  • Prior management experience obtained by direct or matrix team leadership is required.
  • Proven experience in Health authority inspection preparation and management (backroom and front room) is required.
  • Candidate must be familiar with and be able to interpret relevant regulations, regulatory agency inspection expectations e.g. FDA, EMEA, Health Canada, etc.