Senior Manager, Quality Systems & CMC

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 Senior Manager, Quality Systems & CMC. As our Senior Manager, Quality Systems & CMC, you will be accountable for managing the site compliance and regulatory functions to ensure that the company’s Quality systems and Regulatory Compliance Systems are conforming to domestic and international standards and regulatory requirements. You will Coordinate key site Quality Systems including those related to: CMC, GAP Analysis, Change Control, Risk management, Quality Council, QC/QA Systems SOPs, etc. This position must comply with all security guidance, environmental health and safety regulations, and the current Good Manufacturing Practices required by the job function.

Duties and Responsibilities:
  • Develops the strategy to foster site sustainable compliance and lead site regulatory inspection readiness.
  • Performs as the site Liaison with Corporate Regulatory for filing/dossier changes and submissions.
  • Develops, directs, and executes Internal Audits to independently evaluate conformance to cGMP.
  • Provides support in the Internal Audit Plan for the site against the Technical Operations requirements,business requirements and regulatory expectations for the audit program.
  • Manages audit observation, investigations, change control and CAPAs records in Trackwise on timelymanner.
  • Communicates and escalates business critical issues to senior management.
  • Supports CMC (Chemistry, Manufacturing & Controls) filing data verification activities in conjunction with Technical Services department.
  • Provides technical guidance and quality assurance support in the transfer of new products and process to maintain quality standards.
  • Leads the Change Control and Risk management program and the overall site Quality System.
  • Influence in the critical thinking to identify the potential risk during multidisciplinary exercise.
  • Participates in Manufacturing Alignment Teams (MAT) and Project Alignment Teams (PAT), department staff, planning and change control board meetings. Change Control System Chair- person back up as required.
  • Supports risk analysis process when a quality event has happened that cannot be solved immediately.
  • Plans and executes the PAI readiness audits to support new product approvals and product transfers.
  • Acquires and understands site regulatory history to identify vulnerabilities and establish action plan forremediation.
  • Provides mentoring and coaching on the site regulatory expectations/ interpretation, as the Compliance SME, and performs regulatory research to assist in formulation of regulatory/compliance strategic decisions.
  • Represents Compliance on cross functional Technical Operations projects.
  • Creates, communicates, and supports commitment to quality and compliance standards.
  • Evaluates the global assessments of regulatory observations from other sites.
  • Supports and/or lead domestic or international regulatory inspections including the response to observations.
  • Supports the Associate Director Compliance and Audits role in the preparation of the area budget, and onthe decision making process related to compliance issues.


Role Requirements:
  • Bachelors Degree in Science (e.g. Biology, Chemistry, Pharmacy or Engineering) with eight (8) years' of experience in the Biopharmaceutical industry in Quality, Compliance / Auditing functions in a Technical or Regulatory position.
  • Or Masters Degree with five (5) years of experience in the Biopharmaceutical Industry in Quality, Compliance / Auditing functions in a Technical or Regulatory position.
  • Direct experience working in a domestic and/or international board of health.
  • Thorough knowledge of CMC and compendia requirements.
  • Auditor experience interacting with regulatory agencies domestic and international.
  • Direct experience leading and conducting CGMP audits and pre-approval inspections of Drug product facilities.
  • Experience with detailed written audit reports, investigation and summary reports.
  • Organizational leadership and conflict resolution skills, ability to manage multiple projects.
  • Significant experience and technical knowledge in three or more of the following areas: Biopharmaceutical Manufacturing, Quality Assurance, Validation, Quality Control, Biotechnology, Facility & Utilities, Materials Management, Medical Devices.
  • Clear and decisive manner thinking.
  • Ability to communicate difficult observations in a calm and cogent manner.
  • In-depth knowledge of quality systems principles and applications to the Biopharmaceutical industry.
  • Ability to work independently or with groups of people/teams in a complex changing environment.
  • Excellent oral and written communication skills (Spanish and English).
  • Proficient in Technical Writing skills in English/Spanish.
  • Possesses broad based knowledge in FDA and EMEA CGMP regulations.
  • Working knowledge in PC’s.
  • Willing to work irregular hours, rotational shifts, weekends and holidays, when necessary.

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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