Senior Specialist, QA Operations Investigations

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.

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