Senior MSAT Investigations Leader - Cell Therapy, 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 the 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 Control

Staying current with industry trends and BMS standards and participating in best practice forums consistent with function responsibilities.

Knowledge, Skills,&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&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

Working Conditions Position may require working in cleanroom manufacturing environment approximately 15% of the time. Remainder of work is performed in an office environment.

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On‑Site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site‑essential, site‑by‑design, field‑based and remote‑by‑design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site‑essential roles require 100% of shifts onsite at your assigned facility. Site‑by‑design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration,innovation, productivity, and a positive Company culture. For field‑based and remote‑by‑design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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R1602525 : Senior Manager, MSAT Investigations

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