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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

Functional Area Description

PDQ Good Manufacturing Practice (GMP) serves as the Quality Assurance Unit overseeing manufacture, testing and distribution of clinical supplies (investigational products) to assure quality and compliance with Good Manufacturing Practices (GMP) and other applicable regulations and internal procedures.

Key responsibilities include

• Oversight of packaging and labelling operations at the BMS Moreton site

• Product certification and release by the EU/UK Qualified Person,

• Audit of internal GMP systems/processes and suppliers/third party contractors,

• Assist stakeholders with regulatory advice

• Preparation for and management of regulatory agency inspections

Principal Position Purpose

Performs specific quality related functions such as materials/products releasing to ensure compliance with GMP regulations and company standards , Change Control, QRM, Quality/GMP training, quality incident investigations, support of Internal and Regulatory inspections

Key Responsibilities

• Review and approval of Clinical batch documentation and clinical materials.

• Provide Quality oversight, review and approval of Deviations, CAPAs and Change Controls

• Responsible for providing support to the QRM process

• Responsible for interpreting policies, procedures and industry quality regulations and adapting them to quality systems at Moreton.

• Responsible for representing Moreton in the development of global procedures and projects and providing deliverables in-line with project completion and production schedules.

• Responsible for coordinating and implementing ad hoc GxP training programs at Moreton.

• Provides guidance and leadership on quality issues to GPS operations and acts as a PDQ representative on various interdisciplinary teams.

• Review of Standard Operating Procedures, Work Instructions and Procedural

• Provides PDQ support in the preparation of contractual agreements with vendors, where a quality agreement component is required.

• Works with a minimum of supervision and effectively across all levels of the organization.

Key Stakeholders/Contacts

• Product Development (PD)

• Research & Development

• Global Product Development and Supply (GPS)

• Other BMS functions as appropriate

• Contract & external partners

• Clinical Supply Chain

Required Qualifications

• Minimum BSc (Hons) in related science field or equivalent

Required Experience

• Extensive experience in a Quality Assurance role within the pharmaceutical industry.

• Demonstrated strong knowledge of ICH/GMP, regulatory guidelines/directives, and principles of Quality Assurance

• Experience in dealing with regulatory agencies.

• Proven track record of building/ maintaining high-performance teams/organizations and influencing/ motivating global teams to achieve results—delivering on business and program goals.

• Exemplary leadership / influence management skills with ability to foster partnerships in the matrix organization across functional/ geographic/ cultural/partner boundaries.

• Proven clear communication supporting delivery for the business.

Key Competencies

• Experience in dealing with regulatory agencies.

• Extensive knowledge of pharmaceutical development process.

• In-depth knowledge of GxP regulations.

• Exceptional interpersonal and communication skills and solid report writing ability.

• Computer literacy (Microsoft Office, Veeva and SAP environment).

Travel Requirements

Travel may be required for this position and is anticipated to be approximately 5 % of the time.

Employee will be occasionally exposed to a GMP manufacturing environment, but all environmental safeguards will be implemented.

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/ (https://careers.bms.com/eeo-accessibility) 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: R1580968

Updated: 2024-05-17 01:01:52.186 UTC

Location: Moreton-GBR

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.