Associate Director, Regulatory Compliance
Posted on Apr 6, 2021 by Bristol-Myers Squibb
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Major Duties and Responsibilities
The Associate Director, Regulatory Compliance reports directly to the Senior Director, Regulatory Compliance, and shall apply strong project management, leadership, and interpersonal relationship skills to accomplish the following responsibilities that include but are not limited to:
Work collaboratively with the Global Performance Management and External Engagement Team 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 enterprise 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.
Review all Notifications to Management across the enterprise 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 across the end to end product lifecycle to identify and implement opportunities to advance benchmark performance.
Seek opportunities for simplification and efficiency across the enterprise and lead the codification of streamlined ways of working in network SOPs.
Partner with functional Quality teams, especially Cell Therapy and 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 as requested, review and advise on regulatory notification strategy.
Working with others within the Regulatory Compliance and External Engagement organization, 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.
Actively lead and/or participate in the sharing of best practices and lessons learned to embrace evolving regulations/expectations.
Collaborate across sites and with headquarters staff to standardize and improve processes.
Work collaboratively with the Global Performance Management & External Engagement group to 1) Participate, as needed, as an SME in BMS PEARL process which assesses evolving regulatory changes; 2) Contribute to the development of FLASH reports which are intended to be rapid communications to the network regarding emerging GxP information; and 3) Refine and monitor quality and compliance operational leading and lagging performance indicators across the GxP network implementing and advancing compliance action plans, as needed, and seek 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.
Education - B.S. or BA in Natural Science (Chemistry, pharmacy, biology, chemical engineering or a related pharmaceutical science). Master or advanced degree preferred.
8 - 10 years 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. Cell Therapy experience preferred.
Experience leading or supporting sites or functions 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 and compliance 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 critically and 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