Senior Specialist, QA Compliance

Bristol Myers Squibb; Fingal; Vor Ort; EUR 70.000 - 95.000; Vollzeit

Benefits dieser Stelle

Annual bonus

Pension contribution

Family health insurance

27 days annual leave

On-site gym

Life assurance

Zusammenfassung

Bristol Myers Squibb’s Cruiserath Biologics site seeks a Senior Specialist, QA Compliance on a one-year fixed-term basis. You will support Data Integrity, AI Governance, quality agreements and supplier quality, collaborating with site and global teams to uphold rigorous compliance and quality standards.

The role involves audits, inspections readiness, documentation control and continuous improvement, fostering a culture where data integrity and patient safety guide everyday decisions.

Qualifikationen

• Bachelor's degree in Science, Engineering, Quality, IT or related discipline.
• Minimum 3 years experience in Quality Assurance, Quality Control, Supplier Quality, Manufacturing or similar in pharma/biopharma.
• Solid understanding of current Good Manufacturing Practice requirements in pharma/biologics.
• Experience with pharmaceutical quality systems (deviations, investigations, CAPAs, change controls, QRM, controlled docs).
• Strong analytical and problem-solving skills for risk-based quality decisions.
• Ability to work independently and in cross-functional teams.
• Commitment to compliance, continuous improvement and quality culture.

Aufgaben

• Develop, implement and maintain Cruiserath Data Integrity Programme.
• Review and approve Data Integrity Risk Assessments and related docs.
• Develop and operate Cruiserath AI Governance Programme.
• Monitor AI systems and use cases per site requirements and risk management.
• Stay aligned with corporate regulatory expectations and industry developments.
• Draft and approve Quality Agreements with suppliers and external parties.
• Participate in internal audits and inspections and manage CAPAs and observations.
• Support Health Authority inspections readiness and documentation.
• Assist supplier qualification and oversight, including audits and corrective actions.
• Review/approve quality system docs: deviations, investigations, CAPAs, change controls, QRM, SOPs.
• Authorize QA procedures, guidance documents and training materials.
• Support Operational Excellence and continuous improvement within QA Compliance.
• Promote quality culture and patient safety in day-to-day decisions.

Kenntnisse

GMP knowledge

Quality systems

Audits

Documentation

Analytical skills

Cross-functional teamwork

Problem solving

Independent worker

Ausbildung

Bachelor's degree in Science/Engineering/Quality/IT

Jobbeschreibung

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 Senior Specialist, QA Compliance on a one-year fixed term basis.
Reporting to the Senior Manager, QA Compliance, the Senior Specialist will support the development, implementation and ongoing operation of key site compliance programmes, including Data Integrity, Quality Agreements and Artificial Intelligence Governance.

The role will support the execution of the Cruiserath Data Integrity Programme, including the review and approval of Data Integrity Risk Assessments, development and maintenance of the Site Data Integrity Master Plan, and oversight of associated remediation activities.

The Senior Specialist will also support the development and ongoing monitoring of the site Artificial Intelligence (AI) Governance Programme, helping to ensure that Artificial Intelligence systems and use cases are managed in accordance with applicable BMS requirements, regulatory expectations and quality risk management principles.

This role will also support Supplier Qualification activities through review, update and creation of Quality agreements.

The successful candidate will work collaboratively with site and global stakeholders to support internal audits, Health Authority inspections, BMS internal inspections, supplier quality activities and the continued development of a strong quality and compliance culture.

Key Responsibilities

• Support the development, implementation and maintenance of the Cruiserath Data Integrity Programme.

• Review, assess and approve Data Integrity Risk Assessments, ensuring that identified risks are appropriately documented, evaluated and managed.

• Support the development, implementation and ongoing operation of the Cruiserath AI Governance Programme.

• Support the assessment and governance of Artificial Intelligence systems and use cases within the site, including ongoing monitoring and periodic review activities.

• Monitor applicable corporate requirements, regulatory expectations and industry developments relating to Data Integrity and Artificial Intelligence Governance, and support the assessment of their applicability to site operations.

• Draft, review and approve Quality Agreements with suppliers, service providers, contract laboratories and other external parties, as applicable.

• Participate in BMS internal audits and self-inspections, including audit preparation, conduct, documentation of observations and follow-up of associated corrective and preventive actions as required.

• Support Health Authority inspections, including inspection readiness activities, preparation of supporting documentation, inspection room support and coordination of responses.

• Support supplier qualification and oversight activities, including supplier audits, supplier assessments and follow-up of supplier corrective actions, as required.

• Support the review, assessment and approval of quality system documentation, as applicable, including:

• Deviations and investigations

• Corrective and preventive actions

• Change controls

• Quality risk assessments

• Standard operating procedures

• Author, review and approve QA procedures, guidance documents, training materials and other controlled documentation.

• Support Operational Excellence and continuous improvement initiatives within QA Compliance and across the wider site.

• Promote a strong quality culture and contribute to an environment where compliance, data integrity and patient safety are embedded in day-to-day decision-making.

Qualifications & Experience

• A Bachelor’s degree in Science, Engineering, Quality, Information Technology or a related discipline.

• A minimum of 3 years experience in Quality Assurance, Quality Control, Supplier Quality, Manufacturing or a similar function within the pharmaceutical or biopharmaceutical industry.

• A clear understanding of current Good Manufacturing Practice requirements and their application within a pharmaceutical or biologics manufacturing environment.

• Experience working with pharmaceutical quality systems, such as deviations, investigations, CAPAs, change controls, quality risk management or controlled documentation.

• Strong analytical and problem-solving skills, with the ability to evaluate information and make objective, risk-based quality decisions.

• The ability to work independently and use initiative, while also working effectively as part of a cross-functional team.

• A demonstrated commitment to compliance, continuous improvement and quality culture.

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

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 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.

R1607601 : Senior Specialist, QA Compliance