Senior Manager, MSAT Investigations, Leiden

Position Summary

The Senior Manager, Investigations, starts as an individual contributor and will become a people leader to lead a team that provides investigations support to the Leiden Cell Therapy Manufacturing Facility when workload increases. The Senior Manager will build a team and establish processes for investigations, corrective and preventative actions, audit readiness, APQR, and product complaints.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 ControlStaying current with industry trends and BMS standards and participating in best practice forums consistent with function responsibilities Knowledge, Skills, and Abilities

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

Hires, integrates, and develops high quality talent capable of delivering against site and 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 departmentsSupports organizational strategic goals and objectives 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 adviceEducation and Experience

Knowledge of science generally attained through studies resulting in a Bachelor's degree in science, engineering, biochemistry or related discipline, or equivalent Minimum of 10 years’ experience in biopharmaceutical operations with 4+ years of prior management experience Experience leading investigations, performing root cause analysis, and identifying corrective and preventative actionsExperience in cell therapy, biologics, or vaccine manufacturing/support Experience 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 Working Conditions

Position may require working in a cleanroom manufacturing environment approximately 15% of the time. The remainder of work is performed in an office environment. Equal Employment Opportunity

BMS is an equal opportunity employer and is committed to providing reasonable accommodations for people with disabilities. Qualified applicants with arrest and conviction records may be considered pursuant to applicable laws.

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