Senior Specialist, QA Operations Shopfloor, Leiden

Working with us means contributing to groundbreaking cell‑therapy solutions at Bristol Myers Squibb (BMS) in the Netherlands. The Sr. Specialist, QA Operations Shopfloor will oversee quality activities at the Cell Therapy Facility (CTF) in Leiden, ensuring compliance with BMS policies, global cGMP standards, and applicable regulatory requirements.

Duties/Responsibilities

Perform QA shopfloor activities.

Ensure manufacturing compliance with applicable procedures and batch records.

Perform real‑time review of manufacturing batch records.

Review manufacturing shopfloor documentation.

Critically review investigations and generate technical conclusions consistent with Quality risk management principles.

Plan, organize, and build relationships in support of production operations.

Apply knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and Corrective and Preventive Actions (CAPAs) management.

Education/Experience/ Licenses/Certifications

Bachelor's degree in engineering or a life/physical science related field (biology, biochemistry, chemistry); or high school diploma / associate’s degree with equivalent education and work experience.

4+ years of cGMP experience in a biopharma or cell‑therapy manufacturing setting; 1+ year of manufacturing site experience preferred; familiarity with FDA/EMA regulations preferred.

Qualifications

Action‑oriented with strong decision‑making, relationship‑building, problem‑solving, conflict‑management, planning, organizing, resource allocation, coaching, and analytical skills.

Understand continuous improvement and enhance efficiency and productivity within a team or project.

Build relationships internally and across cross‑functional teams.

Sound knowledge of regulated cGMP warehousing, quality, compliance environments; knowledge of GMP manufacturing processes preferred.

Lead quality initiatives that improve site quality system efficiencies.

Recognize and resolve quality issues, inform management of proposed solutions, and seek guidance on complex matters.

Identify conflict and recommend resolution strategies.

Demonstrate an independent mindset; work is self‑directed.

Handle complex tasks with moderate direction; perform routine tasks with minimal supervision.

Confident in making decisions for non‑routine issues.

Develop and revise procedures.

Interpret results and situations, articulating recommendations for resolution.

Prepare written communications and clearly convey problems to management.

Multitask effectively.

Knowledge of global cGMP requirements.

BMS is an equal‑opportunity employer. All qualified applicants receive consideration for employment regardless of race, color, religion, sex, national origin, age, disability, or any other protected characteristic. For more information, please visit the BMS Equal Employment Opportunity page.

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