Director, Sustainable Compliance Lead

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.

Bristol-Myers Squibb in Manati, PR is looking for a remarkable Director, Sustainable Compliance Lead to join our phenomenal team! As our Director, Sustainable Compliance Lead, you will supports the definition and development of the Quality Compliance Plan Strategy. You will also lead the execution of the Quality Compliance Plan as it relates to the operations of the Manati Site including a sustainability phase to ensure a high level of cGMP compliance and the safety, efficacy, and quality of internally manufactured commercial Bio/Sterile drug products.
This role will ensure a timely & effective deployment of the Compliance plan/efforts in all the quality and operational aspects at the Manati Site to assure adherence to an Acceptable status of GMP/Quality/Regulatory Compliance requirements.

MAJOR DUTIES AND RESPONSIBILITIES:
  • Ensures alignment between the Global Quality strategy and the Quality Compliance Plan strategy.
  • Supports the definition and development of the Quality Compliance Plan as it relates to the operations of the Manati Site.
  • Leads the execution of the Quality Compliance Plan Strategy as it relates to the operations of the Manati Site, including a sustainability phase to ensure a high level of cGMP compliance and the safety, efficacy, and quality of internally manufactured commercial Bio/Sterile drug products.
  • Works closely with key stakeholders at the Site (Operations, Engineering, Warehouse, QA/QC, etc.) to ensure agreement and alignment with proposed future business processes resulting from the QCP.
  • Anticipates risk and builds contingencies to help mitigate compliance risk on site.
  • Works closely with the Executive Director, IMQ Biologics Sterile Drug Product Compliance and the Manati Site General Manager to ensure alignment and balanced actions that allows for the uninterrupted supply while leading the compliance remediation efforts.
  • Ensure a timely & effective deployment of the remediation plan/efforts in all aspects of cGMP at the Manati Site to assure adherence to an Acceptable status of GMP/Quality/Regulatory Compliance requirements.
  • Responsible to provide senior management updates as part of the established Governance forums.
  • Provides leadership direction for a multi-functional group of operations professionals, aligned with company culture that recognizes market practices and regulatory trends to achieve a uniform sustainable compliance state. Specifically, the Third-Party Consultants, Compliance WS Leads, PMOs, Consultants or other quality professionals of Manati Site dedicated to this remediation effort.
  • Support audits and Health Authority inspection for the Manati Site, including the assistance in the generation of HA responses.
  • Establishes a process to closely monitor that all critical and major issues, which may have an adverse effect on the quality of the product or represent a risk of supply, are escalated as per standard procedures to the ED, IMQ Biologics Sterile Drug Product Head, General Manager and Site Leadership Team and are resolved within stated timelines.
  • Supports communication and development of effective strategies & partnership with the Manati Site Leadership Team.
  • Creates and drives a culture of quality and continuous improvement focused on ensuring quality first which in return will maximize efficiencies and will ensure timely delivery of products to our patients.
  • Coaches, leads, and mentors the operations support team and builds a highly capable team through the attraction, training, and development of the necessary skilled professionals to meet business needs.


ROLE REQUIREMENTS:
  • BS or BA in Natural Science, Chemistry, Pharmacy, Biology, Engineering, or a related pharmaceutical science.
  • Fifteen (15) years progressive experience in one or more areas of pharmaceutical operations, pharmaceutical research and supply chain.
  • Five (5) years of experience leading technically complex projects, including parenteral operations, in a pharmaceutical manufacturing environment.
  • Extensive knowledge and experience in pharmaceutical operations, manufacturing, engineering, manufacturing technology and supply chain.
  • Deep knowledge and understanding of manufacturing processes associated with parenteral manufacturing.
  • Knowledge of cGMPs, best manufacturing practices, regulatory health authorities CMC requirements, EHS regulations & compliance.
  • Fully bilingual - written and oral English and Spanish.
  • Experience in project management of complex projects involving cross-functional teams.
  • Strategic thinker with the ability to translate strategy into action with short, medium, and long terms plans. Strategic thinker who sees the bigger picture and possesses high business acumen. Understands how the parts affects the whole business (end-to-end enterprise) and makes the best decisions for the whole organization.
  • Well organized and capable of managing multiple projects with respect to priorities.
  • Expertise in critical thinking, influence, negotiation, problem solving, strategic thinking and leadership in a highly matrixed environment.
  • Ability to drive work and get results as well as take risks and drive decisions.
  • Ability to connect and collaborate across cross-functional organizations in both sites and headquarters (e.g., Operations, Manufacturing Technology, Quality, Supply Chain, Finance, Engineering) to enable development and execution of realistic plans.
  • Excellent communication and interpersonal skills, with the ability to interface with a broad range of internal and external stakeholders at all levels of the organization.
  • Has a proven record of delivering results, is action oriented, and has work directly with Compliance remediation activities.
  • High degree of adaptability in dealing with an ambiguous, complex and highly paced work environment, balances.

BMSBL, VETERAN

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 adastaffingsupport@bms.com . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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

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