Bristol Myers Squibb Company

Manager, Regulatory Compliance

Location
New Brunswick, NJ, United States
Posted
Sep 11, 2020
Ref
R1526365
Required Education
Bachelors Degree
Position Type
Full time
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.

As a member of the Regulatory Compliance team, the Manager plays a key role in supporting and contributing to the execution of the regulatory compliance strategy. This will include: 1) Responsibility for working collaboratively across the enterprise to provide strategic GxP compliance support to assure adherence to global health authority requirements across the product lifecycle 2) Fostering a Compliance Excellence mind set through early action on issues of potential impact to operations, supply, or quality compliance and 3) Promoting transparency in information sharing and excellence in quality through the monitoring of internal and external trends including those from emerging regulations, guidance, evolving expectations, inspections and quality issues in the GxP space.

The Manager will help drive the strategy for regulatory compliance and will, on a tactical level, execute compliance and inspection support programs in a matrixed organization. This role will also work collaboratively with the Governance and Performance Management group to monitor inspection trends and identify other compliance leading and lagging performance indicators across the network. This role will interact and collaborate extensively with teams and leaders across the BMS network.

Reporting Structure

This position is part of the Global Quality Organization and will report to the Director, Regulatory Compliance.

Major Duties and Responsibilities

The Manager, Regulatory Compliance should apply strong project management, team work and interpersonal relationship skills to accomplish the following duties and responsibilities:

GxP Regulatory Inspection Support
  • Work collaboratively with the Governance and Performance Management group to monitor inspection trends and identify other compliance leading and lagging performance indicators across the network.
  • As required, work with fuctional Quality teams (GLP, GCP, PV, GMP) to assist in the preparation and management of global regulatory inspections. This may include the development and facilitation of inspection readiness training.
  • Communicate the outcome of health authority inspections to key stakeholders.
  • Manage documents supporting the Global Regulatory Observation and Evaluation (GROe) process and assist with GROe evaluations and Lessons Learned sessions when needed.
  • Maintain the inspection intelligence database and other repositories on SharePoint.
  • As required, support INFINITY Wave 3 and other regulatory inspection initiatives.

GxP Compliance Support
  • Deepen knowledge in the GxPs, with emphasis on GLP, GCP and PD support.
  • As needed, provide support to the functional GxP areas on difficult investigations or issues
  • Support the development of FLASH reports to ensure the network is informed of emerging external trends and news in the industry.
  • As required, support the review of new and changing regulations and regulatory guidance for compliance impact. Identify and communicate compliance trends (PEARL).
  • Work with the Regulatory Compliance group and across the GxP network to advance a Compliance Excellence mindset.
  • 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 GxP network.
  • Establish and administer programs for measuring compliance through pertinent key performance indicators and provide periodic reports to management.
  • Lead and participate in quality and compliance projects and programs.

Provide creative and innovative ideas to move the Regulatory Compliance group forward to address current and future challenges.

Required Knowledge/Skills/Qualifications

Education:
  • B.S. or B.A.; Master or advanced degree preferred.

Experience/Knowledge:
  • 3-5 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.

Skills/Competencies:
  • Experience supporting regulatory inspections and in depth knowledge of one or multiple GxPs.
  • Experience working in and influencing across cross-functional, matrix teams.
  • Ability to collaborate across the network to standardize and improve processes.
  • Customer-focused and continuous improvement mindset.
  • Demonstrated ability to act on decisions while balancing speed, quality and risk.
  • Ability to think clearly and in a decisive manner; remain calm under adverse conditions.
  • 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. Working knowledge of quality systems principles and applications.
  • Demonstrated ability to work independently and with groups of people/teams in a complex changing environment.
  • Proficiency with MS Office, SharePoint, and documentation management sytems.
  • Excellent oral and written communication skills.


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.