Manager. External Manufacturing QA, Packaging & Labeling

Company: Bristol Myers Squibb
Location: Summit
Posted on: January 27, 2023

Job Description:

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

The External Manufacturing Quality Manager will provide Quality oversight for the selection of contract manufacturing organizations used for the manufacture, packaging, testing and distribution of Clinical Supplies in accordance with corporate policies, procedures and GMPs. The incumbent will cover multiple products at the Contract Service Provider (CSPs) and will report to the Associate Director, External Manufacturing QA Lead.

Key Responsibilities and Major Duties
Oversees the Vendor Quality Management Systems:

Partner with Technical Operations to identify and qualify manufacturing facilities for the Manufacture, Packaging and testing of Clinical Products.

Serves as the BMS Quality single point of contact for the assigned CSPs with responsibility for Quality and Compliance performance.

Ensures Complaints, Deviations, Stability and CAPAs are managed in a compliant and timely manner.

Oversees vendor change control process and ensures that BMS products are manufactured in full compliance with all applicable regulations.

Implement the process to achieve Vendor Quality Qualification with appropriate continued monitoring to ensure maintenance of status.

Partners with Technical Operations to identify Quality and Compliance risks and develop / implement plans to mitigate via a risk management approach.

Develop Quality metrics as part of a balanced scorecard to assess ongoing monthly performance.

Final Quality approver for all GMP documentation associated with Batch Records, Investigation Protocols etc.

Participates in Corporate Vendor Audits/Visits.

Key Requirements:
BS/MS in a Scientific discipline, preferably in Chemistry or Pharmacy. 3 years' experience in Pharmaceutical quality and may be combined with relevant Pharmaceutical industry experience.

Hands-on CMC experience of clinical manufacturing and/or packaging. Periods spent in Clinical manufacturing operations would be considered advantageous.

Experience managing external vendor is required.

Ability to work independently and with cross-functional matrix team.

In-depth knowledge and understanding of GMP and Quality regulations.

#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.

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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

COVID-19 Information
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. -Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. -This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation 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 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.

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