Job Information
Bristol Myers Squibb Associate Director, Qualified Person in Moreton, United Kingdom
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 rich in diversity. 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
Position Purpose
BMS is looking to recruit on a permanent contract an Associate Director, PDQ Qualified Person 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 that may affect BMS.
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 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
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
Team leadership
Knowledge of GMP compliant Quality Management System implementation especially with clinical GMP requirements
In vestigation and incident management
A udits and inspections
Co mmunicating 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 an inclusive culture, promoting diversity 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 a diverse 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.
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.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Bristol Myers Squibb is Disability Confident - Committed
A UK Government scheme
Company: Bristol-Myers Squibb
Req Number: R1582319
Updated: 2024-07-05 03:04:37.489 UTC
Location: Moreton-GB
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.