Manager, Compliance

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 searching for an exceptional Manager, Compliance and Auditing. As our Manager, Compliance and Auditing, you will be responsible for maintaining several elements within the Quality Systems frame work to ensure the Site compliance with current and forthcoming Biopharmaceutical and Medical Devices industries Good Manufacturing practices regulations and BMS policies. Incumbent must comply with Corporate and HR Policies, FDA, GMP, internal/external audit, and any other regulatory requirements. Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.

  • Acknowledge, conducts and/or approve investigations for Customer Complaints, External Complaints, approve Regulatory Corrective Actions and Preventive Actions (CAPA), Vendor Certification, Quality Agreements, Annual Product Review/Report for Finished Product and Systems and site licenses.
  • Supports readiness of the facility for Regulatory Inspection. Assists the Associate Director Compliance and auditing during regulatory agencies inspections such as FDA / EMEA and/or during internal company audits. Documents any FDA communication between Site and agency.
  • Conducts internal / external audits following annual site plan with respective reports and actions items from areas impacted during the audit. Ensures the site has an internal audit program and that all system audits are conducted at a specified frequency. Create, review approves and track corrective actions related to internal and external audits.
  • Prepares, submit and discuss reports of assigned Quality Systems status for trending and evaluation to the site management.
  • Provides site GMP training based on annual requirements and support and training to other departments to ensure quality compliance as needed.
  • Generates, reviews and implements departmental procedure and forms to assure compliance with current practices or GMP’s trends.
  • Assures that site complies with Corporate Systems by evaluating, implementing and enforcing the company policies and guidelines.
  • Ensures that Quality and Compliance is implemented in laboratory and operational areas and maintains it according with regulatory agencies expectations.
  • Manages document including record retention program, compliance and custody of SOP’s, and review / approval /issuance of master documentation related to operational areas and; evaluates compliance of all procedure(SOP’s) and master documentation with regulations and BMS Policies.
  • Provides guidance and support on the transfer and introduction of new products and processes to the site to maintain quality and compliance.
  • Support the Site Master File (SMF) and assists our regulatory section to handle and update documentation as part of our filing.
  • Coordinates Fact Findings documentation following Worldwide Quality and Compliance Directive and conducts root cause analysis to guarantee that underlying problems are identified and resolved.
  • Support Field Alert Report/Biological License Application (FAR/BLA) and Recall investigations and provides tracking to any Site Planned deviation. Ensures that recall operations are capable of being initiated promptly and at any time. This includes that lists are maintained of customers of all batches distributed and of distribution information.
  • Supports the Quality Risk Management program at the site participating in multidisciplinary teams.
  • Provides support to the Associate Director Compliance and Auditing in the preparation of monthly Quality Council meeting and presentations.
  • Develops impact assessments related to Policies and Directives implementation. Ensures corporate policies and directives are implemented in a timely fashion, following pre-establish schedule.
  • Ensures that all current vendors are qualified and conduct audits of approved Third Party Manufacturers and other vendors at defined frequencies as part of the vendor monitoring process as part of the Supplier Management Program.
  • Support the Inspection Readiness Program.
  • Provides support to Site Projects.
  • Provides compliance oversight and verifying compliance with BMS and WWQ&C Policies and Guidelines and site cGMP compliance policies and procedures are addressed.
  • Provides compliance oversight and verifying compliance with BMS Policies, guidelines and regulations.
  • Liaison for regulatory initiatives.
  • Manages Licenses renewals.
  • Supports product submissions.
  • Manages the Records Retention program.
  • Creates, evaluates, follows up and approves Change controls for the Manati site, including interaction with corporate support areas, other BMS sites and third parties.
  • Ensures Change controls are created according to local SOPs and corporate directives with all the appropriate requirements in placed for each change control.
  • Ensures the site has an internal audit program and that all system audits are conducted at a specified frequency.
  • Enforces critical analytical thinking in the Change Control management process.
  • Provides scientific input into change controls program management to assure all requirements to complete a change control are properly established and that no requirements are missing.
  • Supports actively the engineering, laboratories and Supply chain areas for Quality and Compliance documentation and site oversight providing coaching from Quality perspective.
  • Provides guidance on gaps identified from the review and actively participates to determine potential remediation activities.
  • Provides technical guidance and quality assurance support in the transfer of new products and process to maintain quality standards.
  • Participates in Manufacturing Alignment Teams (MAT) and Project Alignment Teams (PAT), department staff, planning and change control board meetings as required.
  • Maintains communication with internal and external customers to ensure compliance and timely completion of the assigned activities.
  • Evaluates OP’s, BR’s, BOM’s, WPP’s, qualification and validation Protocols, according with government regulations and BMS Policies.

Education & Experience:
  • Bachelor Degree in Chemical, Engineering, Biology or Microbiology Science.
  • Five 5 years of experience in Quality Unit responsibilities in the pharmaceutical industry.
  • Fully Bilingual (Spanish/English) communication skills, both written and verbal are required.
  • Strong knowledge of relevant GMP, FDA, EU regulations.
  • Expert in the interpretation and application of regulations according with the intended use.
  •  Self-motivated, creative and team work oriented.
  • Excellent interpersonal skills and the ability to interact with people at all levels.
  • Strong Technical Writing Skills to prepare trends analysis, investigation reports and regulatory and internal audits responses.
  • Self-motivated, creative and team work oriented.  Self starter and good organizing and planning skills.
  • Excellent knowledge of computer systems (Microsoft Office, etc.) and tracking system like QCIS and Trackwise.
  • Strong knowledge and experience in statistical tools.
  • Strong presentation skills.
  • Able to exercise good judgment.
  • Able to work under pressure Willing to work irregular hours, rotation shifts, weekends and holidays, when necessary.
  • Sense of urgency and analytical thinking are some of the critical competencies required for this position.


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 to access our complete Equal Employment Opportunity statement.

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