Specialist, QA Disposition

Biopharma Careers; Leiden; Hybrid; EUR 60,000 - 80,000; Full time

Job summary

Bristol Myers Squibb in Leiden, The Netherlands, is seeking a Specialist Quality Assurance Disposition to support release and disposition activities within the Cell Therapy Facility. You will ensure product quality and compliant documentation under cGMP, collaborating with cross-functional teams.

The role covers SAP-based release deliverables, batch record reviews, SOP evaluations, and guidance to staff. A strong background in regulated environments and excellent communication are essential to

Qualifications

• Experience with cGMP manufacturing, Quality, and/or compliance is desired.
• Strong attention to detail and personal accountability are critical.
• Excellent communication skills and ability to follow instructions.
• Experience working on cross-functional teams with measurable results.
• Knowledge of SAP, Veeva, LIMS/Celabs, Infinity or EBR systems preferred.

Responsibilities

• Procedures, training, and business processes supporting drug product disposition.
• Prepares documentation and deliverables per SOPs required for drug product disposition.
• Verify accuracy and acceptability of drug product documentation, such as COA or deviation reports.
• Perform the review of lot genealogy for all raw materials and components used in each lot.
• Works in electronic systems such as SAP, Learning Management, and Document Management systems.
• Leads troubleshooting sessions with internal and external stakeholders when required.
• Supports day-to-day operations with guidance to less experienced staff.

Skills

cGMP experience

Attention to detail

Communication skills

Team collaboration

Quality/compliance knowledge

Education

Bachelor's degree in engineering or life sciences

High school diploma/Associate degree acceptable

Tools

SAP

Veeva

LIMS/Celabs

Infinity

Electronic batch recording

Job description

Working with Us

Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

Position summary

The Specialist Quality Assurance Disposition is responsible for supporting quality and disposition activities at the Cell Therapy Facility (CTF) in Leiden, The Netherlands, in accordance with Bristol Myers Squibb (BMS) policies, standards, procedures and global current Good Manufacturing Practice (cGMP). The role aids in the routine and timely release of drug product and assure the quality of manufactured products is in compliance with all applicable regulations and guidelines.

Functional responsibilities include preparing deliverables for product release within the inventory management system (SAP), ensuring accurate and timely maintenance and review of batch record documentation, providing operations shopfloor oversight, and performing document issuance for manufacturing. This individual is responsible for reviewing departmental Standard Operating Procedures (SOPs) and Work Practices.

Responsibilities

• Procedures, training, and business processes supporting drug product disposition.
• Prepares documentation and deliverables per SOPs required for drug product disposition.
• Verify accuracy and acceptability of drug product documentation, such as Certificate of Analysis or deviation reports, to support drug product lot disposition.
• Perform the review of lot genealogy for all raw materials and components used in each lot to ensure that they are approved and released.
• Works in electronic systems such as SAP, Learning Management, and Document Management systems.
• Leads troubleshooting sessions with internal and external stakeholders when required.
• Works on assignments that are moderately complex in nature where judgment is required in resolving problems and making routine recommendations.
• Provides guidance to less experienced staff with atypical events during day-to-day operations.

Qualifications

• Experience with cGMP manufacturing, Quality, and/or compliance is desired.
• Previous work experience where attention to detail and personal accountability was critical to success.
• Strong communication skills and the ability to follow written and verbal instructions.
• Prior evidence of successful participation on work teams where combined contribution, collaboration, and results were expected.
• Knowledge of electronic systems including any of the following preferred: SAP, Veeva, LIMS/Celabs, Infinity, and electronic batch recording.
• 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 directly relevant experience in a regulated cGMP environment. Prior quality experience is preferred.

#LI-Hybrid

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as "Transforming patients' lives through science", every BMS employee plays an integral role in work that goes far beyond ordinary.

They post 90 - your way

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.

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 [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at [e-mail]. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1604026 : Specialist, QA Disposition