Manager, QA Compliance

Bristol-Myers Squibb; Ireland; Hybrid; EUR 85,000 - 110,000; Full time

Job summary

BMS Cruiserath Biologics is seeking a Manager, QA Compliance to support material qualification and release activities across the manufacturing campus. Reporting to the Senior Manager, QA Compliance Materials Management, the Manager, QA Compliance will support material qualification & release activities for the BMS Cruiserath Biologics Manufacturing campus.

The successful candidate will hold a BSc in science, engineering or a related discipline, along with 4+ years' Quality experience in a

Qualifications

• BSc in science, engineering or related discipline.
• 4+ years' quality experience in a biopharmaceutical environment.
• Clear understanding of cGMP requirements for manufacturing and/or systems and compliance.
• Knowledge of material qualification & SAP would be a distinct advantage.
• Ability to work on own initiative as well as part of a team.
• Excellent communication, presentation, time-management and organizational skills.

Responsibilities

• Support materials management activities for the site, including: Material qualification
• Supplier Change Notifications (SCNs)
• Excipient and Excipient Supplier Risk Assessments
• Material Certification
• Direct dispense program
• QA disposition of raw materials, level 1 & level 2 consumables
• Preparation, review and approval of Material Qualification Documentation
• Authoring, review and approval of QA-related procedures
• Creation, update and maintenance of the QM Master Data in the MDG-M and SAP system
• QA review, assessment and approval activities for Biologics Manufacture: Change controls, Deviations/Investigations, Supplier Investigations, CAPAs, TSE Certificates
• Other associated documentation
• Represent QA as a team member or project lead in operational excellence and cross-functional process improvement teams
• Be a core team member of the QA Systems & Compliance team engaging in other support activities as required.

Skills

QA experience

cGMP knowledge

SAP knowledge

Education

BSc in science/engineering

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 Manager, QA Compliance. Reporting to the Senior Manager, QA Compliance Materials Management, the Manager, QA Compliance will support material qualification & release activities for the BMS Cruiserath Biologics Manufacturing campus.

Key Responsibilities

• Support materials management activities for the site, including: Material qualification
• Supplier Change Notifications (SCNs)
• Excipient and Excipient Supplier Risk Assessments
• Material Certification
• Direct dispense program
• QA disposition of raw materials, level 1 & level 2 consumables.
• Preparation, review and approval of Material Qualification Documentation.
• Authoring, review and approval of QA-related procedures.
• Creation, update and maintenance of the Quality Management (QM) Master Data in the Material Data Governance-Master (MDG-M) and Systems, Applications and Products (SAP) system.
• QA review, assessment and approval activities for Biologics Manufacture, as applicable, for: Change controls
• Deviations/Investigations
• Supplier Investigations
• CAPAs
• TSE (Transmissible Spongiform Encephalopathy) Certificates
• Other associated documentation
• Represent QA as a team member or project lead in operational excellence and cross-functional process improvement teams.
• Be a core team member of the QA Systems & Compliance team engaging in other support activities as required.

Qualifications & Experience

The successful candidate will hold a BSc in science, engineering or a related discipline, along with 4+ years' Quality experience in a biopharmaceutical 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.

The successful candidate will be required to work on their own initiative in addition to working as part of a team. Excellent communication, presentation, time-management and organizational skills are essential.

Employees are expected to display the BMS Biopharma Behaviours, 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 will be part of a 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

#LI-Hybrid

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 [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/

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.c