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 communication skills.
• 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 Degree required preferably in chemistry, biology, engineering,
pharmacy or related pharmaceutica