Senior Specialist QAC Materials Management

Bristol Myers Squibb; Ireland; On-site; EUR 60,000 - 90,000; Full time

Benefits offered by this job

Annual bonus

Pension contribution

Family health insurance

27 days annual leave

On-site gym access

Life assurance

Job summary

Bristol Myers Squibb (BMS) Cruiserath Biologics seeks a Senior Specialist, QA Compliance Materials Management to support material qualification and release for its biologics portfolio at the Cruiserath facility. The role reports to the Senior Manager, QA Compliance and requires a strong QA background in biologics/pharmaceuticals.

You will be part of a core QA Compliance Materials Management team, driving improvements and ensuring regulatory and quality standards are met across supplier changes,

Qualifications

• BSc in Science or related discipline with min 3 years QA experience.
• Clear understanding of cGMP requirements for manufacturing/systems.
• Knowledge of material qualification and SAP is a plus.
• Ability to work independently and in a matrix team to meet timelines.
• Excellent communication and presentation skills are essential.

Responsibilities

• Prepare, review and approve Material Qualification Documentation.
• QA disposition of raw materials and consumables.
• Authoring, review and approval of QA-related procedures.
• QA review, assessment and approval for Biologics Manufacture, incl. change controls.
• Handle Deviations/Investigations and Supplier Investigations.

Skills

BSc in Science

QA Experience

cGMP knowledge

SAP familiarity

Teamwork

Communication

Education

BSc in Science or related discipline

Tools

SAP

Job description

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

BMS Cruiserath Biologics is seeking to recruit a Snr Specialist, QA Compliance Materials Management.

Reporting to the Senior Manager, QA Compliance, the Specialist will support the material qualification and release activities for the Cruiserath manufacturing facility for its biologic’s commercial portfolio and clinical pipeline.

Key Responsibilities

• Preparation, review and approval of Material Qualification Documentation.
• QA disposition of raw materials, level 1 & level 2 consumables.
• Authoring, review and approval of QA-related procedures.
• QA review, assessment and approval activities for Biologics Manufacture, as applicable, for: Change controls
• Deviations/Investigations
• Supplier Investigations
• CAPAs
• Supplier Change Notifications (SCN)
• TSE (Transmissible Spongiform Encephalopathy)Certificates
• Other associated documentation

• Be a core team member of the QA Compliance Materials Management team engaging in other support activities as required.
• Support establishment of Operational Excellence initiatives e.g., 5S / Std Work / LSW / Kaizen / Problem Solving etc.

Qualifications & Experience

The successful candidate must possess:

• BSc in Science or related discipline with a minimum of 3 years’ QA or related experience in a Biologics or Pharmaceutical environment
• A clear understanding of cGMP requirements for manufacturing and/or systems and compliance
• Knowledge of material qualification & SAP would be a distinct advantage.
• Required to work on his/her own initiative in addition to working as part of a team. Must be able to work across a team matrix to meet accelerated timelines.
• Excellent communication and presentation skills are essential.
• Excellent time management and organizational skills along with a proven ability to multi-task.
• Employees are expected to display the BMS Biopharma Behaviors, which enable them to be successful and perform at their highest level.

Why you should apply

• You will help patients in their fight against serious diseases
• You willbe part ofa company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
• You’ll get a competitive salary and a great benefits package including, but not only, an annual bonus, pension contribution, family health insurance, 27 days of annual leave , access to BMS Cruiserath on-site gym and life assurance

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 workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin 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 qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only:

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/

For roles based in Washington State only:

If you live in or expect to work from Washington State if hired for this position, please visit this page for important information about the Washington Fair Chance Act.

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 this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1607779 : Senior Specialist QAC Materials Management