Bristol-Myers Squibb Company

Director, Regulatory Compliance

Location
New Brunswick, NJ, US
Posted
Jun 27, 2018
Ref
R1507721
Required Education
Bachelors Degree
Position Type
Full time
This position reports directly to the Vice President, Regulatory Compliance and External Engagement and is responsible for working collaboratively across GPS and specifically across Global Integrated Quality regarding GxP compliance to provide strategic GxP compliance support to assure adherence to global health authority requirements across the product lifecycle. On an as needed basis, the Regulatory Compliance Leader will work collaboratively across GPS and specifically across Global Integrated Quality on tactical GxP compliance support. The Regulatory Compliance Leader is responsible for advancing a Compliance Excellence mind set and has a unique opportunity to lead transformational change along GPS' journey to a culture of excellence and working across the Global Integrated Quality organization to streamline and simplify by taking an end-to-end integrated approach to quality and compliance across the product lifecycle. In addition, the Regulatory Compliance Leader will act under the direction of the the Vice President, Regulatory Compliance and External Engagement and will act as the Center of Excellence on compliance matters such as regulatory notifications, market action fact finding investigation and associated market action activities. The Regulatory Compliance Leader will work collaboratively with the External Engagement Leader to assess current policies and directives to ensure that they meet and/or exceed GxPs, create new and revised policies and directives, participate, as needed as an SME in BMS' PEARL process which assesses evolving regulatory changes. The Regulatory Compliance Leader will also work collaboratively with the Governance and Performance Management Leader to refine and monitor quality and compliance operational leading and lagging performance indicators across the network implementing and advancing compliance action plans, as needed, and seeking opportunities to work collaboratively with peers and other stakeholders to proactively identify areas for enhancement and develop and implement cohesive solutions that benefit the broader organization.

Major Duties and Responsibilities:

The Regulatory Compliance Leader reports directly to the Vice President, Regulatory Compliance and External Engagement, with job responsibilities that include but are not limited to:

• Work collaboratively with the Governance and Performance Management Leader to refine and monitor quality and compliance operational leading and lagging performance indicators across the network, review periodically compliance and quality operational metrics across the GxP network to proactively identify emerging trends, including the development and implementation of appropriate action plans to ensure continuous improvement and to ensure compliance now and in the future.

• Harmonize and maintain the Notification to Management process (e.g., NTM tracker) across GxPs. In conjunction with the Governance and Performance Management Leader, review all Notification to Management across the GxP network to proactively identify emerging trends, including the development and implementation of appropriate action plans to ensure continuous improvement and to ensure compliance now and in the future.

• Develop and maintain partnerships with across the end to end product lifecycle to identify and implement opportunities to advance benchmark performance.

• Seek opportunities for simplification and efficiency across the GxP network and lead the codification of streamlined ways of working in network SOPs.

• At the discretion of the Vice President, Regulatory Compliance and External Engagement, work with fuctional Quality teams (GLP, GCP, PV, GMP) to assist in the preparation and management of global regulatory inspections. Assist in the generation of holistic written responses to regulatory inspectional observations and/or health authority reports, as requested.

• As a SME and in accordance with BMS directives, attend market action fact finding (MAFF) investigations and advise on the need to convene the Product Review Committee.
  • As a SME and as requested from time to time, review and advise on regulatory notification strategy.

• Working with VP, Regulatory Compliance and External Engagement and across the GxP network, generate new approaches to advance a Compliance Excellence mindset.

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

• Inspire transformative thinking and motivate employees to deliver transformative performance

• Lead and/or participate in the sharing of best practices and lessons learned to embrace evolving regulations/expectations.

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

• The Regulatory Compliance Leader will work collaboratively with the External Engagement Leader to assess current policies and directives to ensure that they meet and/or exceed GxPs, create new and revised policies and directives, participate, as needed as an SME in BMS' PEARL process which assesses evolving regulatory changes.

Education:
  • B.S. or BA in Natural Science (Chemistry, pharmacy, biology, chemical engineering or a related pharmaceutical science).
  • Master or advanced degree preferred.


Experience / Knowledge Desired:
  • Minimum of 15 years of experience in the biopharmaceutical Industry in a Manufacturing, Quality, Technical, or Regulatory position or a combination thereof and/or working with a regulatory health authority.
  • Experience leading or supporting commercial manufacturing sites through global health authority inspections is desirable.
  • Ability to identify and implement phase-appropriate compliance strategies to support the E2E product lifecycle.
  • Demonstrated ability to apply effective risk management approaches that provide a proactive means of identification and control of potential quality issues.
  • Demonstrated experience leading through influence and working in cross functional / matrix teams to investigate and manage quality and compliance related issues.
  • Demonstrated ability to make and act on decisions while balancing speed, quality and risk.
  • 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