Senior Specialist, QA Compliance

Bristol-Myers Squibb; Cruiserath; On-site; EUR 70,000 - 90,000; Full time

Job summary

Bristol Myers Squibb at Cruiserath Biologics seeks a Senior Specialist, QA Compliance on a one-year fixed-term basis. You will help develop and operate key site compliance programmes, including Data Integrity and AI Governance, and support supplier qualification and internal audits.

The role collaborates with global stakeholders to uphold quality culture and patient safety. The role emphasizes regulatory compliance, quality risk management and documentation control across QA systems and site

Qualifications

• Bachelor's degree in Science, Engineering, Quality, Information Technology or a related discipline.
• 3+ years experience in Quality Assurance, Quality Control, Supplier Quality or related pharma functions.
• Solid understanding of current Good Manufacturing Practice and quality systems.

Responsibilities

• Support development, implementation and maintenance of Cruiserath Data Integrity Programme.
• Review and approve Data Integrity Risk Assessments and quality documentation.
• Support AI Governance Programme and supplier qualification activities.
• Participate in internal audits, inspections and CAPA processes.
• Assist with health authority inspections and supplier oversight as required.
• Prepare documentation and participate in change controls, deviations, investigations and QA procedures.

Skills

Quality Assurance

QA Documentation

Regulatory Compliance

Audit Readiness

Cross-functional Collaboration

Education

Bachelor's degree in Science, Engineering, Quality, IT or related discipline

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 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,
  • 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

The successful candidate must possess:

• 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 complia