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Senior Manager, MSAT Investigations

  • Bristol-Myers Squibb
  • Leiden
  • Contract duration unspecified
  • Full Time
  • Published: 1 day ago
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Senior Manager, MSAT InvestigationsBristol-Myers Squibb
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Your responsibilities

Duties/Responsibilities:

  • Providing direct supervision of a team of lead investigators
  • In partnership with Quality Assurance, establishing, maintaining, and executing the investigations, CAPA, and product complaints programs
  • Performing Root Cause Analysis Investigations for complex deviations and trend deviations.
  • Establishing and reporting metrics for compliance activities (investigations, CAPAs, training, commitments, etc.)
  • In collaboration with Quality Assurance, providing oversight of Investigations/CAPA management to ensure timely and compliant closure
  • Representing the Site MS&T Investigations team in cross-functional forums
  • Performing review and approval of site and department SOPs
  • Ensuring safe and compliant cGMP operations and maintaining permanent inspection readiness; Actively supporting regulatory inspections
  • Interacting with other teams including Process Engineering, Manufacturing Operations, Quality Assurance, Supply Chain Operations, Site Engineering, and Quality Control
  • Staying current with industry trends and BMS standards and participating in best practice forums consistent with function responsibilities.

Your profile

Knowledge, Skills, and Abilities

  • Proficient in cGMP’s and multi-national biopharmaceutical/cell therapy regulations
  • Excellent verbal/written communication skills and ability to influence at all levels
  • Ability to think strategically and to translate strategy into actions
  • Ability to prioritize and provide clear direction to team members in a highly dynamic environment

Leadership:

  • Hires, integrates, and develops high quality talent, capable of delivering against the site & department goals and objectives
  • Defines and enforces performance measures; provides developmental feedback and coaching
  • Creates an environment of teamwork, open communication, and a sense of urgency which enhances unit performance and integration across site departments
  • Supports organizational strategic goals and objectives that are linked to the overall company strategy
  • Champions continuous improvement, problem solving, and incident prevention initiatives
  • Drives strong collaboration within the Leiden Cell Therapy Manufacturing Facility and across the network
  • Delivers business results through timely and quality decision making and advice

EDUCATION AND EXPERIENCE

  • Knowledge of science generally attained through studies resulting in a Bachelor’s degree in science, engineering, biochemistry or related discipline, or its equivalent is required
  • A minimum of 10 years’ experience in biopharmaceutical operations with 4+ years of prior management experience required
  • Experience leading investigations, performing root cause analysis, and identifying corrective and preventative actions required
  • Experience in cell therapy, biologics, or vaccine manufacturing/support required
  • Experience in building and growing an organization into a high performing team
  • Experience with Operational Excellence and Lean Manufacturing is a plus
  • Experience in product complaints and APQRs is a plus

We offer

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as “Transforming patients’ lives through science ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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Bristol-Myers SquibbLeiden, Nederland

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