Senior Specialist, QA Compliance

• 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.

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 compliance, continuous improvement and quality culture.

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

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.