Associate Director, Qualified Person

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Bristol Myers Squibb (BMS) is looking to recruit an experienced Associate Director, PDQ Qualified Person on a permanent contract, reporting to the Director of PDQ at the Moreton site. 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 the identification and resolution of critical quality issues that may affect BMS.

• Support all on site GMP activities
• Qualified Person release of IMP’s
• Review and approval of QA/QP-related procedure
• Support review and approval of Quality Agreements
• Ensure knowledge transfer from current release site
• Support Manufacturers Authorisation submissions
• Support related regulatory inspection in the capacity of Subject Matter Expert
• Support sustaining operations
• Accountable for Health Authority GCP/GDP inspections and audits across the supply chain
• Oversees/provides QP compliance consultation to stakeholders on quality issue management and process enhancement/compliance - ensuring consistent quality standards and fostering effective working relationships
• 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, including potential misconduct or issues of significant deviations with project/products, to business partners and senior management
• Lead multidisciplinary or cross-functional work/project teams; serve as part of strategic team(s) within the group/discipline
• Provide guidance and expectations to the business to enable execution of external and internal regulations on a global and cross functional level
• Proactively identify risk areas - brings ideas and strategies to the forefront and has a firm grasp of the business needs.
• Undergo continuous professional development including self-study, site visits, internal and external training courses and audits
• 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 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, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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 adastaffingsupport@bms.com.

Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. Bristol Myers Squibb is Disability Confident – Employer A UK Government scheme.

Candidate Rights BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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.