QA Manager - Analytical QA

Location
New Brunswick, NJ, United States
Posted
Sep 19, 2020
Ref
R1529763
Required Education
Bachelors Degree
Position Type
Full time
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Key responsibilities
  • Conducts, plans, schedules, or supervises the review and approval of contract testing laboratory data, and other documentation as needed.
  • Reviews and approves documents related to Quality Systems such as contract laboratory (CTL) laboratory investigation reports (OOT, OOS), change controls, release/stability/reference standard/critical reagents (RSCR) protocols, reports etc. and coordinates stakeholder input as needed.
  • Demonstrated ability to assess the right balance between quality decisions, technical considerations and business implications.
  • Drafts, reviews, and/or negotiates Quality Agreements, as requested.
  • Supports CTL during regulatory agency and third party inspections, as needed.
  • Participate in CTL Operational Review meetings (ORM) and provide performance feedback and other input including metrics as needed.
  • Brings to the attention of the PDQ Management, any information relating to the impact of legislation on the functions of the department, system deviations, etc.
  • Performs or supports risk assessment efforts as needed.
  • Provides reports to Management related to timely CAPA implementation, as requested.
  • Build and foster strong relationships and partnerships with stakeholders and support groups to meet the demands of a changing business culture and environment.
  • Provides input and support for continuous improvement/OpEx efforts as needed.
  • Provides instruction and guidance on quality issues and serves as a resource.
  • Adherence to BMS core behaviors.


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.
  • A Ph.D. in a related science with 4-6 years of relevant experience within the pharmaceutical or healthcare industry, or a M.S. with 7-9 years experience, or a B.S. with 9-11 years experience; including 3-5+ years experience in a regulated function.
  • Demonstrated knowledge and understanding of analytical test methods for biologic/pharma products.
  • Experience within a QA/QC environment is required.
  • Technical expertise in resolution of deviations, root cause analysis and development of effective CAPA.
  • Experience in Quality Management at development and/or commercial stage of pharmaceutical/biologics operations.
  • Broad experience in the manufacturing of sterile and non-sterile products.
  • Demonstrated knowledge of regulatory and compliance expectations (cGMP, ICH and other quality guidelines).
  • Strong problem solving, interpersonal and organizational skills.
  • Strong collaborative and influencing skills.
  • Effective written and verbal communication.
  • Computer literacy: Microsoft Office and SAP environment, Infinity/Veeva, Trackwise®, PDLIMs, and other systems as required.


Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.