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Job Details


Bristol Myers Squibb

Senior Manager Compliance and Auditing

Technology

Development Manager

No

Manati, Puerto Rico, United States

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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. Read more: careers.bms.com/working-with-us

Knowledge and skill requirements:

  • Bachelor Degree in Science (Chemical, Engineering, Biology, Pharmacy or Microbiology)

  • Eight (8) years of experience in Quality Operations responsibilities in a pharmaceutical industry with emphasis in compliance/auditing functions.

  • Knowledge of manufacturing operations of Oral Solid Dosage and Parenteral Products Manufacturing

  • Strong knowledge of relevant GMP, FDA, EU regulations and the ability to interpret and apply them for intended use

  • Fully bilingual (Spanish/English) communication skills, both written and verbal.

  • Self-motivated, creative and team work oriented

  • Strong knowledge in validation activities

  • Technical and scientific capability to establish quality philosophy Excellent interpersonal skills and the ability to interact with people at all levels

  • Effective communication Skills

  • Sense of urgency and analytical thinking

  • Proficient knowledge of computer systems (Microsoft Office etc.) and applications like Trackwise and SAP

  • Solid ability for analyzing data detecting deviations, inconsistencies and interpret sampling test results

  • Proficient knowledge of problem solving and root cause analysis methodologies (i.e. Kepner Tregoe)

  • Willing to work irregular hours, rotate shifts, weekends and holidays when needed

Major Duties and responsibilities:

  • Responsible of QMS implementation.

  • Responsible of GROE Compendial Updates.

  • Ensures renewals of licenses are done in the required dates.

  • Serve as the Regulatory Liaison.

  • Responsible of Health Authority Notifications.

  • Updates the Site Master File (SMF) and assists our regulatory section to handle and update documentation as part of our filing.

  • Support readiness of the facility for Regulatory Inspection.

  • Support CAPA Program and ensure report metrics in the Monthly Quality Council meetings, reporting progress and follow-up to regulatory CAPA’s. Updates site and global metrics to assure performance indicators are shared in the appropriate forums on time.

  • Approve product complaint investigations and escalate any expedite event in a timely manner.

  • Participates in Compliance activities such as, investigations, external complaints, Quality Agreements, Annual Product Review/Report for Finished Product and Systems and site licenses, MAFF, Agency Notification Quality Council, Risk Management, planned deviations, licenses renewals among other compliance department activities when needed.

  • Leads Mock Recall inspection and support recall program Assists the Director Compliance & Auditing during regulatory agencies inspections such as FDA / EMEA and/or during internal company audits.

  • Documents any FDA communication between Site and agency.

  • Creates, communicates, and supports commitment to quality and compliance standards.

  • Evaluates the global assessments of regulatory observations from other sites. Supports and/or leads domestic or international regulatory inspections including the response to observations.

  • Supports and executes the Pre-Approval Inspection (PAI) readiness audits to support new product approvals and product transfers. Identifies regulatory vulnerabilities and establishes action plan for remediation by understanding site regulatory history.

  • Supports the Director Compliance and Audits in the preparation of the area budget, on the decision-making process related to compliance issues and would be appointed to be in charge during the area AD absences.

  • Creates, communicates, and supports commitment to quality and compliance standards.

  • Manages the development, impact assessment and implementation of Quality Systems Directives and Policies following corporate schedule

  • Reviews and approves procedures related to regulatory commitments to ensure; that the procedures are properly followed and adequate for their use and verifies consistency with other site procedures and in alignment to regulatory commitments.

  • Ensures compliance with regulatory commitments Verifies consistency with other site procedures and/or specifications

  • Manages the FDA contact reports in the site such as communications between the agency and the firm, also, random visit from FDA officers to exanimate product that required release for domestic market

  • Leads the returned good program at the site in order to facilitate numbering and documentation archiving.

  • Review and approve quarterly environmental reports to assurance compliance and alignment with current regulation requirements.

  • Supports Data Integrity program at the site to ensure it is adherence to BMS practices and guidelines

BMSBL

#LI-Onsite

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.

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.