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.

We are seeking a Manager in the Product Development Quality (PDQ) Compliance & Quality Systems group to both lead and provide compliance support for Product Development (PD) with a primary focus in the area of Self-Inspection, functioning as owner of the PD GMP/GDP Self-Inspection Program.

Key Responsibilities

• Ownership of the PD Self-Inspection Program governing documentation.

• Drive program requirements and compliance through the planning, execution, and documentation of GMP/GDP self-inspections for all PD sites.

• Develop, publish, and communicate the annual PD Self-Inspection Master Plan.

• Develop and define the scope and agenda for PD self-inspections, communicating requirements and expectations to functional area leadership.

• Function as the Lead Inspector during PD self-inspections, managing the inspection team and coordinating closely with functional area leadership and local subject matter experts.

• Identify compliance gaps/concerns and meaningful, value-added recommendations for management to improve the adequacy, effectiveness, and efficiency of controls and related processes.

• Prepare PD self-inspection reports, including clearly written, concise inspection observations that effectively communicate identified issues and their related corrective actions to key stakeholders.

• Support site operations during internal, health authority, and third-party audits/inspections.

• Support routine PDQ Compliance & Quality Systems activities related to QRM, quality agreement management, and master data management as necessary.

Qualifications & Experience

• B.S. or M.S. in Chemistry, Biology, Engineering, Pharmacy, or a related Pharmaceutical science

• 5+ years of Quality experience in the life sciences industry

• Thorough understanding of self-inspection and auditing principles

• Thorough understanding of cGMPs and regulatory requirements (e.g. FDA, EU, ICH)

• Broad experience in the manufacturing, packaging, labeling, and distribution of sterile and non-sterile products would be considered advantageous

• Strong collaborative and influencing skills

• Expert skills with Microsoft Office, SAP, Veeva® and other systems as required

#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.

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.