Associate Director, Qualified Person

Working with Us

Challenging. Meaningful. Life-changing. Bristol Myers Squibb offers work that transforms the lives of patients and the careers of those who do it. Opportunities to grow and thrive exist alongside high-achieving teams.

Position
:
Associate Director, PDQ Qualified Person (permanent contract) – Moreton site. Reports to the Director of PDQ. This is a non-management role within the Pharma Quality organisation, primarily responsible for the UK QP Certification of Investigational Medicinal Products packaged and labelled. The role also provides leadership for identification and resolution of critical quality issues that may affect BMS.

• Support all on site GMP activities
• Qualified Person release of IMPs
• Review and approval of QA/QP-related procedures
• Support review and approval of Quality Agreements
• Ensure knowledge transfer from current release site
• Support Manufacturers Authorisation submissions
• Support related regulatory inspections in the capacity of Subject Matter Expert
• Support sustaining operations
• Accountable for Health Authority GCP/GDP inspections and audits across the supply chain
• Oversee/provide QP compliance consultation to stakeholders on quality issue management and process enhancement/compliance
• Incorporate global regulatory trends and changes into Pharmaceutical Development Quality
• Oversee Site Master File and Manufacturer Authorisation update and maintenance
• Ensure rapid communication of quality issues to business partners and senior management
• Lead multidisciplinary or cross-functional work/project teams; participate in strategic teams within the group/discipline
• Provide guidance to enable execution of external and internal regulations on a global and cross-functional level
• Proactively identify risk areas and align with business needs
• Undergo continuous professional development including self-study, site visits, internal and external training
• Delegate for Director, PDQ Quality, Manager

• University degree (science degree preferred)
• Eligibility to act and demonstrable experience as a UK Qualified Person

• Demonstrated experience working in Quality in a Pharmaceutical company
• Team leadership
• Knowledge of GMP compliant Quality Management System implementation, especially with clinical GMP requirements
• Investigation and incident management
• Audits and inspections
• Communicating with regulatory authorities
• Making significant quality decisions

If you come across a role that intrigues you but doesn't perfectly line up with your resume, you are encouraged to apply. This can be a step toward work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers. On-site protocol and accommodation options, including site-essential, site-by-design, field-based and remote-by-design roles. BMS is committed to supporting people with disabilities and providing reasonable accommodations. For inquiries, contact  See our Equal Employment Opportunity statements at

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R1598416 Associate Director, Qualified Person