At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.
Position Summary
The Senior Specialist, QA Operations Investigations for the QA Operations organization at the CTF in Leiden, is responsible for the quality review and approval of manufacturing and laboratory investigations at the CTF in accordance with Bristol Myers Squibb policies, standards, procedures and global current Good Manufacturing Practice (cGMP). The role will provide Quality oversight and assure the quality of manufactured products are in compliance with all applicable regulations and guidelines.
Duties/Responsibilities:
- Review and approve investigations / Corrective and Preventive Actions (CAPAs) / effectiveness checks associated with the manufacturing site including but not limited to materials, manufacturing, laboratory, facility, and computer systems.
- May author, review, approve technical reports, including but not limited to risk assessments and deviation system monitoring reports, to support the deviations program.
- Ensure the CAPAs are robust and adequately address the root cause.
- May perform routine reporting and analysis of metrics to ensure timely closure of quality events and actions.
- Identifies improvement opportunities and supports execution of site/team continuous improvement goals and projects.
- Support internal and external inspections as required.
- Maintain compliance with assigned learning plan. Support development and delivery of training content to cross functional teams.
- Lead meetings and represent function at cross functional meetings. Share data/ knowledge within and across team. Build and maintain strong relationships with partner functions.
- Perform other tasks at management request.
Qualifications:
- Ability to research, understand, interpret and apply internal policies and regulatory guidelines.
- Proficient computer skills with knowledge of several digital tools like MS Office, Smartsheets etc. and ability to learn and work with new software applications.
- Ability to interpret data and results, understand problems with few variables and critically assess and provide feedback on proposed CAPA.
- Ability to critically review investigation reports, interpret results and assess and challenge technical conclusions consistent with Quality risk management principles.
- Excellent verbal and technical writing skills with ability to prepare written communications and present technical data to management with clarity and accuracy.
- Ability to work in a fast-paced team environment and changing priorities.
- Detail oriented and task focused with ability to meet deadlines and support work prioritization.
- Able to work across functional groups and teams to ensure requirements are met.
- Self-motivated and contribute to a positive team environment.
- Confident in making decisions for minor issues and able to recognize Quality issues and solve problems.
- Curious and ability to think critically to create innovative solutions.
Education/Experience/Licenses/Certifications:
- Bachelor's degree in engineering, a life or physical science related field (including biology, biochemistry, chemistry) is preferred. High school diploma/ Associate’s degree with equivalent combination of education and work experience is acceptable.
- 4+ years of experience in a regulated industry with 1+ year deviation experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
- Demonstrated experience with electronic system and databases.
- Demonstrated experience in root cause analysis tools including but not limited to 5-WHY, Human error prevention, Ishikawa Diagram (Fishbone Analysis), Process Flow Diagram, etc.
#LI-Onsite
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We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.
How We Work
Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.
Supporting People with Disabilities
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Candidate Rights
BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
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R1607462 : Senior Specialist, QA Operations InvestigationsSkills Required
- Bachelor’s degree in engineering, biology, biochemistry, chemistry, or another life or physical science field; equivalent education and experience may be accepted.
- At least 4 years of experience in a regulated industry.
- At least 1 year of deviation investigation experience.
- Experience with electronic systems and databases.
- Experience using root cause analysis tools, including 5-Why, Human Error Prevention, Ishikawa/Fishbone Analysis, and Process Flow Diagrams.
- Experience with FDA and EMA regulations in biopharmaceuticals or cell therapy manufacturing.
- Ability to interpret and apply internal policies and regulatory guidelines.
- Ability to critically review investigation reports, evaluate technical conclusions, and assess CAPAs using quality risk management principles.
- Strong technical writing, verbal communication, data presentation, and cross-functional collaboration skills.
- Proficient computer skills and ability to learn new software applications.
Bristol Myers Squibb Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Bristol Myers Squibb and has not been reviewed or approved by Bristol Myers Squibb.
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Fair & Transparent Compensation — Pay is considered fair and competitive for the pharmaceutical sector, with many describing compensation as good or better than expected. Feedback suggests base pay combined with incentives contributes to overall satisfaction.
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Healthcare Strength — Health coverage is broad, combining medical, dental, vision, disability, and wellness programs, along with access to on‑site fitness. Feedback suggests employer contributions to health accounts and wellbeing incentives further strengthen perceived value.
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Retirement Support — Retirement savings are reinforced by a strong 401(k) match and additional plan options. This structure is commonly cited as a standout component of total rewards.
Bristol Myers Squibb Insights
What We Do
At Bristol Myers Squibb, we work every day to transform patients’ lives through science. That work inspires some of the most interesting, meaningful, and life-changing careers you’ll experience. Join us and pursue innovative ideas alongside some of the brightest minds in biopharma, collaborating with a team rich in diversity of experiences, and perspectives. We have built a sustainable pipeline of potential therapies and are leveraging translational medicine and data analytics to understand how we can deliver the right medicine to the right patient, at the right time, to achieve the best outcome. Whether in a scientific, business or supporting function, a career at BMS means you’ll be inspired every day to grow and thrive through opportunities that are uncommon in scale and scope. Here, you’ll be on the cutting edge of powerful innovation in oncology, hematology, immunology, cardiovascular disease, and fibrosis, with colleagues united in the mission to help patients. Through the Bristol Myers Squibb Foundation, we also promote health equity and seek to improve health outcomes of populations disproportionately affected by serious diseases and conditions. Our mission is to give new hope to help patients prevail over serious disease – it drives everything we do.
