Associate Director, Regulatory Compliance
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
Principle Objective of Position
This position is part of the Global Quality Organization and will report to the Senior Director, Regulatory Compliance. As a member of the Regulatory Compliance team, the Associate Director plays a pivotal role in supporting and contributing to the execution of the regulatory compliance strategy. This includes working collaboratively across GPS, and specifically across Global Integrated Quality regarding GxP compliance to provide strategic and tactical compliance support to those GxP functions. The Associate Director, Regulatory Compliance is responsible for advancing a Compliance Excellence mindset within Global Quality and across our network to meet or exceed global health authority requirements and expectations across the product lifecycle, and serve our patients.
In addition, the Associate Director, Regulatory Compliance will act under the direction of the the Senior Director, Regulatory Compliance and will act as the Center of Excellence on compliance matters such as regulatory notifications, events escalated through the Notification to Management process, and regulatory inspection preparedness. The Associate Director, Regualtory Compliance will also actively engage in the regulatory inspection, and Quality Council processes, and monitor other compliance related processes (e.g. corporate audits) to examine and trend compliance indicators across the enterprise.
The Associate Director, Regulatory Compliance will work collaboratively with the Global Performance Management and External Engagement Team to: 1) Participate, as needed, as an SME in the PEARL process to assess evolving regulatory changes and impact to BMS processes; 2) Prepare Flash Reports to communicate to the network emerging regulatory news and updates that may impact the business.
Major Duties and Responsibilities
The Associate Director, Regulatory Compliance reports directly to the Senior Director, Regualtory 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 fuctional Quality teams (GLP, GCP, Patient Safety) 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.
• B.S. or BA in Natural Science (Chemistry, pharmacy, biology, chemicaJ 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.
• 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.
• Up to 20%
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.
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Job posted: 2020-06-15