Manager, QA Compliance

Bristol-Myers Squibb; Munster; On-site; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Competitive salary

Comprehensive benefits

Job summary

BMS Cruiserath Biologics is seeking a Manager, QA Compliance to support material qualification and release activities. Reporting to the Senior Manager, QA Compliance Materials Management, you will collaborate on QA review of change controls, deviations, investigations, CAPAs and maintain MDG-M/SAP data.

The successful candidate will hold a BSc in science or engineering with 4+ years of quality experience in a biopharmaceutical environment, and strong knowledge of cGMP and SAP.

Qualifications

• 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.
• Excellent communication, presentation, time-management and organizational skills are essential.

Responsibilities

• Support materials management activities for the site, including material qualification.

Skills

Quality experience

cGMP knowledge

SAP knowledge

Education

BSc in science or engineering

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

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

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.

We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.