Director, GXP Compliance

Job Description
Job Description
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. And driven to make a difference, from innovative research to hands-on community support. 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 the resources to pursue their goals, both at work and in their personal lives.

This position reports directly to the Vice President, Global Biologics Quality and is responsible for working collaboratively with the Global Biologics Quality (GBQ) and site Compliance leadership teams to provide tactical and strategic GMP compliance support to the Global Biologics Quality organization. The GBQ Compliance Leader is responsible for advancing a Compliance Excellence mind set and has a unique opportunity to lead transformational change along GMS’ journey accelerating to benchmark. In addition, the Compliance Leader will act under the direction of the GBQ Senior Leadership team in leading / coordinating select market action fact finding investigations and associated market action activities. The Compliance Leader will be the single point of contact for GBQ for creating new and revised policies and directives, assessing evolving regulatory changes (e.g., BMS ReACT process), refining and monitoring quality and compliance operational leading and lagging performance indicators across the biologics network, leading Business Unit Quality Council meetings, implementing and advancing compliance action plans, and seeking opportunities to work collaboratively with peers and other stakeholders to identify gaps and develop and implement cohesive solutions that benefit the broader organization.

Major Duties & Responsibilities:

The Director Compliance Leader reports directly to the Vice President, Global Biologics Quality, with job responsibilities that include but are not limited to:

• Generate, refine and monitor compliance and quality operational metrics to include both leading and lagging performance indicators for commercial and development manufacturing and testing sites

• Working with the GBQ Leadership team, analyze metrics to assess trends and develop and advance action plans to drive continuous improvement.

•Develop and maintain partnerships with global site Quality Leaders to identify and implement opportunities to advance benchmark performance.

• Working with the Operational Excellence team, act as the business unit Quality point person for identifying and coordinating the execution of operational excellence initiatives to advance the Quality and A3 Strategic Plans.

• At the discretion of the Biologics Quality VP, work with site Quality teams to assist in the preparation and management of global regulatory inspections. Assist in the generation of holistic written responses to regulatory inspectional observations as requested.

• Under the direction of the Biologics Quality VP and according to BMS Directives, lead and coordinate select market action fact finding (MAFF) investigations to include coordinating MAFF meetings and issuance of meeting minutes. Make recommendation for need to convene the Product Review Committee meeting to assess need for market action; assist in the coordination of Health Authority responses or notifications.

• Working with the Biologics Quality VP, generate new approaches to advance a Compliance Excellence mindset.

• Seek opportunities to work collaboratively with peers and other stakeholders to identify gaps and develop and implement cohesive solutions that benefit the broader organization.

• Establish and/or maintain the Biologics Business Unit Quality Plan in alignment with and in support of the Global Quality Strategic Priorities.

• Inspire transformative thinking and motivate employees to deliver benchmark performance

• Seek to share best practices and lessons learned to embrace evolving regulations/expectations and address inspection findings.

• As a member of the GBQ Leadership team, collaborate across sites and with headquarters staff to standardize and improve processes.

• As the single point of contact for GBQ, assure robust new and revised policies and directives to assure compliance with evolving regulatory expectations, participate and/or lead assessments of evolving GMP regulatory changes as part of the BMS ReACT process.

• Provide Quality due diligence and/or compliance audit support as requested.


Requirements

· B.S. or BA in Natural Science (Chemistry, pharmacy, biology, chemical engineering or a related pharmaceutical science).
· Master or advanced degree preferred. Minimum of 15 years experience in the pharmaceutical Industry in a Quality, Technical, or Regulatory position or a combination thereof and/or working with a regulatory health authority. Expertise in biological drug substance and drug product manufacturing highly desirable.
· Direct experience leading or supporting commercial manufacturing sites through global health authority inspections required.
· Ability to identify and implement phase-appropriate compliance strategies to support the product development continuum
· Demonstrated ability to apply effective risk management approaches to provide a proactive means of identification and control of potential quality issues
· Demonstrated experience leading through influence and working in cross functional teams to investigate and manage quality and compliance related issues.
· Demonstrated ability to make and act on decisions while balancing speed, quality and risk.
· Implementation/leadership of lean labs and/or operational excellence in quality systems highly desirable
· Knowledge in Drug Product Manufacturing, Quality Assurance, Validation, Quality Control, Regulatory Affairs, and Technology Transfer.
· Ability to think clearly and in a decisive manner; remain calm under adverse conditions.
· In-depth knowledge of quality systems principles and applications.
· Demonstrated ability to work independently and with groups of people/teams in a complex changing environment.
· Excellent oral and written communication skills.
· Ability to work in a matrix environment and build strong relationships by being transparent, reliable and delivering on commitments.
· Ability to provide innovative, compliant ideas or alternatives that create value including seeking new information and external insights.
· Pragmatic in approach with demonstrated ability to make sound, risk-based decisions

Company

Bristol-Myers Squibb Co

Job Code

State or Province

New Jersey

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