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Senior Manager, Investigations, Cell Therapy

Bristol Myers Squibb
Devens - MA, United Statesfull_timeVerifiedPosted 22 Aug 2024

About the role

Working with Us
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.

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. Read more: careers.bms.com/working-with-us.

Position: Senior Manager, Investigations, Cell Therapy

Location: Devens, MA facility

(on-site) Monday to Friday 8:00am to 4:30 pm

Key Responsibilities

  • Responsibilities include, but are not limited to, the following:
  • Direct supervision of a team of lead investigators
  • In partnership with Quality Assurance, establishes, maintains, and executes the investigations, CAPA, and product complaints programs.
  • In collaboration with Quality Assurance, provides oversight of Investigations/CAPA management to ensure timely and compliant closure.
  • Facilitates the lead investigator training & certification program.
  • Represents the Site MS&T Investigations team in cross-functional forums & projects.
  • Performs review and approval of site and department SOPs.
  • Maintains permanent inspection readiness; Actively supports regulatory inspections.
  • Interacts with other teams including Manufacturing Operations, Process Support/Engineering, Manufacturing Support, Quality Assurance, Supply Chain Operations, Site Engineering, and Quality Control
  • Stays current with industry trends and BMS standards and participates in best practice forums consistent with function responsibilities.

Leadership:

  • Hires, integrates, and develops high quality talent who can deliver 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 through analytical & risk-based thinking; Makes recommendations and implements actions to meet strategic goals & objectives.
  • Drives the development of efficient, consistent processes, and builds a workplace culture of continuous improvement through strong problem solving/creative skills.
  • Identifies and recommends improvements to the organization, processes, procedures, and the Quality Management System.
  • Delivers business results through timely, quality, and risk-based decision making and advice.

Qualifications & 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 8 years’ experience in biopharmaceutical operations with 2+ 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.
  • Proficient in cGMPs and multi-national biopharmaceutical/cell therapy regulations
  • Excellent verbal and written communication skills to allow effective interactions with all levels of the organization and with a work style that is decisive yet approachable.
  • Strong priority-setting skills, with exceptional attention to detail and the ability to work on multiple projects at the same time.
  • Experience in building and growing an organization into a high performing team.
  • Ability to think strategically and to translate strategy into actions.
  • Experience with Operational Excellence/Six Sigma and Lean Manufacturing is a plus.
  • Experience in product complaints and APQRs is a plus.

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Company

Bristol Myers Squibb

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