Quality Control Manager (Release & Stability) (Chelsea)

Bristol-Myers Squibb Company in Chelsea, MA

  • Type: Full Time
position filled
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Major Duties and Responsibilities:

  • Manage QC staff and/or supervisors in one or more areas performing testing, analysis, and results reporting of Site Operations or Release & Stability samples, for effective operation of the biologics manufacturing facilities at Devens, and/or the Global Biologics Network.
  • Accountable for daily operations of the QC lab(s), including on-time testing, analysis of data and trends, investigations, staff training, and equipment maintenance and calibration. Manage staff schedules to meet workflow demands.
  • Perform data review, trending analyses and preparation of protocols and reports to support areas of laboratory operations.
  • Accountable for cGMP compliance in all aspects of assigned laboratory operations.
  • Provide technical and operational expertise for training and developing staff, assisting in troubleshooting. Supervise investigations for out of specification results.
  • Recruit and develop a high performing team with diverse backgrounds and talents. Create an environment of continuous learning, improvement, and innovation. Coach team in execution of continuous improvement and self-development.
  • Establish, maintain, and communicate team performance metrics.
  • Provide strategic leadership to the assigned QC laboratories, serves as Subject Matter Expert in cross functional / cross departmental work teams, and participates in the site team supporting and managing regulatory inspections and findings.


Knowledge and Skills:

  • Knowledge of science generally attained through studies resulting in a BS in physical or life sciences (e.g., chemistry, biochemistry, molecular biology or related discipline) or its equivalent is required.
  • Minimum of 8 years of experience in a cGMP laboratory area with 3+ years of experience with management of laboratory personnel required preferred.
  • Expertise and operational knowledge of equipment and test methods within the applicable lab area(s) within QC Site Operations or QC Release & Stability.
  • Extensive knowledge of regulatory requirements (e.g., US, EU, USP) and industry best practices. Prior experience supporting regulatory agency inspections preferred.
  • Strong general laboratory and organizational skills, effective communication skills, both oral and written.
  • Demonstrated leadership, interpersonal, communication, and motivational skills with strong problem solving and analytical thinking skills. High attention to detail.
  • Experience in building and growing an organization into a high performance team. Demonstrated capability of influencing in matrix environment.
  • Experience with method validation and technical transfer preferred.
  • Proficient in common computer software applications. Experience with SAP, LIMS and ELN computer applications a plus.


Decision Making:

  • Works on problems of diverse scope in which analysis of situation or data requires evaluation of identifiable and ambiguous factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Utilize organizational insight and influence to deliver program level goals, both at functional and enterprise level. Acts as an advisor to subordinate staff to resolve problems. Develops performance requirements and evaluates subordinates accordingly. Establishes and recommends changes to policies, which affect subordinate organization. Erroneous decisions or failure to achieve goals results in additional costs and personnel, and serious delays in overall schedules.


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 the resources to pursue their goals, both at work and in their personal lives.

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