Associate Director, Quality Systems & Compliance

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. 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.

​Key responsibilities:

• Assure the quality of manufactured products complies with all applicable regulations and guidelines.
• Oversee regulatory Compliance & Data Integrity implementation across quality programs within the Product Development Network to ensure adherence to BMS standards and global health authorities requirements.
• Work collaboratively with the Product Development functional areas to provide strategic direction, to support and drive compliance at the sites, training and ensuring that robust quality systems are in place.
• Manages the Data Integrity program and identifies attributes in potential situations or issues and process systematic solutions across the PD Network.
• Manage the development, implementation, and sustainability of quality and technical training solutions for Data Integrity Program for Quality Operations and the Product Development network.
• Supports annual internal audits conducted by the Global GMP/GDP Audit function.
• Supports third party audits conducted by alliance partners.
• Supports the creation, review, approval, and tracking of corrective actions related to Compliance from internal/external audits.
• Leads Quality Management System integrations as part of company acquisitions/mergers.
• Manages and acts as Product Development “voice of customer” for Quality system records.
• Supports Training and Document Control/Records Management programs for Product Development.
• Oversees PD data integrity risks, develops contingency plans, ensures remediation efforts are driven to completion ensuring compliance with due dates commitments.
• Oversees the tracking of PD Network DI metrics (investigations, CAPAs, change control, etc.) and reporting at the Quality Council.
• Oversees the development, management, and continuous improvement of procedural documents to ensure a robust, compliant, and efficient Quality System Framework.
• Ensure compliance to applicable Quality Policies, Directives, SOPs, FDA and EU guidance,
• Lead continuous improvement initiatives and drives simplification of processes.
• Adherence to BMS core behaviors.

Specific Knowledge, Skills, Abilities:
•Ascertains that the quality, reliability, and process ability that is designed
into a drug product is built into that drug product.
•Addresses each event timely and properly and provides insight into
potential business disruptions.
•Prioritizes when handling multiple work assignments and deadlines.
Provides clear direction and priorities.
•Demonstrated leadership, interpersonal, and communicationskills.
•Ability to make creative and strategic decisions because of rapid analysis
of information including risk assessment for the patient and the business.

Education/Experience/ Licenses/Certifications:
•Bachelors Degreerequired preferably in chemistry, biology, engineering,
pharmacy or related pharmaceutical science.
•Minimum of 10 years’ experience in regulated function in pharmaceutical
industry (equivalentcombination of education and experience acceptable).
•Demonstrate in-depth knowledge of Data Integrityand Part 11
requirements, risk management, Quality Management Systems, and
GMP/GDP manufacturing processes.
•Experience in Product Development preferred.
•Ability to collaborate with functional stakeholders and demonstrate strong
people management skills.
Travel:This position requires up to 10% of travel

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 a supportive culture, promoting global participation 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 an 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.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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