Associate Director, Qualified Person

7 months ago

North Moreton, United Kingdom Bristol-Myers Squibb Full time

**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.

**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

**Uniquely Interesting Work, Life-changing Careers**

**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 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.

Bristol Myers Squibb is Disability Confident - Committed

A UK Government scheme

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