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. Read more: careers.bms.com/working-with-us .

Why Join Us

• Opportunity to work with a leading global biopharmaceutical company.
• Supportive and collaborative team environment.
• Opportunities for professional growth and development.
• Competitive salary and benefits package.
• 50% office / home hybrid working policy
• Free onsite parking

Required Qualifications

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

Required Knowledge and Experience

• Demonstrated experience working in Quality in Pharmaceutical company
• Experience as an IMP Qualified Person beneficial
• Knowledge of GMP compliant Quality Management System implementation especially with clinical GMP requirements
• Experience with investigation and incident management
• Experience with audits and inspections and communicating with regulatory agencie

POSITION PURPOSE

This is an exciting opportunity for a Senior Manager , PDQ Qualified Person to join Bristol Myers Squibb (BMS) on a permanent bases , 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 at the BMS Moreton site .
The role also provides leadership for the identification and resolution of critical quality issues.

KEY RESPONSIBILITIES

Support all GMP activities on the BMS Moreton site

• 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

• Qualified Person release of IMP’s
• 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
• 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

Required Qualifications

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

Required Knowledge and Experience

• Demonstrated experience working in Quality in Pharmaceutical company
• Experience as an IMP Qualified Person beneficial
• Knowledge of GMP compliant Quality Management System implementation especially with clinical GMP requirements
• Experience with investigation and incident management
• Experience with audits and inspections and communicating with regulatory agencies

LI-Hybrid

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.