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Job Details


Bristol-Meyers Squibb, Co.

Director, Global Quality Compliance

Pharmaceuticals

All

Full Time

On Site

No

Devens, Massachusetts, United States

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.

Responsibilities:

The Quality Compliance Leader reports directly to the Sr. Director Regulatory Compliance, with job responsibilities that include but are not limited to:

  • Ownership of Global Regulatory Observation evaluation process to support the network in proactively identifying and remediating global inspection risks
  • Support on-going regulatory surveillance and industry benchmarking
  • Be a primary BMS representative in external industry forums and
  • Act as the responsible person in line with applicable directives & regulations for the communications with Health Authorities, Recalls and Defect reporting.
  • Harmonize and maintain the Notification to Management and recall process across GxPs.
  • Work with functional GxP Quality teams to assist in the strategic preparation for and management of global regulatory inspections as required and using principles of Quality Risk Management. Assist in the review of written responses to regulatory inspectional observations and/or health authority reports, as requested.
  • In conjunction with the Compliance & Monitoring leaders, 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.
  • The Regulatory Compliance Leader will work collaboratively 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. -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.
  • Working with 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
  • Manage direct reports’ day to day work as well as performance oversight and support staff development efforts

Requirements:

  • B.S. or BA in Natural Science (Chemistry, pharmacy, biology, chemical engineering or a related pharmaceutical science). Master or advanced degree preferred.
  • 10+ years of GMP/GDP Biologics and Pharma experience
  • Minimum of 10+ 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.
  • Proficient people management 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.
  • 15% Travel required

#LI-Hybrid

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to . Visit[Register to View] target="_blank"> [Register to View] to access our complete Equal Employment Opportunity statement.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.