Compliance Specialist

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 Humacao is searching for our next remarkable Compliance Specialist. As our Compliance Specialist, you will be accountable for providing Humacao operations with the appropriate service and advice to assure that site quality systems are in place for regulatory compliance. You will assure that quality systems and programs such as internal audits, annual product reviews, stability, procedures, change controls, gap analysis, complaints, and other are in compliance with GMP regulations. This position must comply with all Security Guidelines, Environmental Health and Safety regulations and current Good Manufacturing Practices required by the job function. The incumbent works with minimum supervision and additional working hours, when required.

MAJOR DUTIES AND RESPONSIBILITIES
  • Assures the site quality systems are in place to avoid any possible regulatory compliance situation at the Site. Manages the different quality systems and programs established at the site such as but not limited to Change Control.
  • Packaging change controls, Stability, Policies and Directives, Gap Analysis, Customer Complaints, TrackWise System, Site Gatekeeper, Regulatory CMC, Internal Audits, Document Control, External Audits, Quality Agreements, Supplier Qualifications, Annual Product Quality Review, and others as assigned.
  • Prepares Annual Product Quality Reviews report for each pharmaceutical finished packaged and bulk drug products manufactured at the Site as per established timelines.
  • Reviews and prepares regulatory documentation intended for government regulatory agencies (e.g. FDA), such as master files, new and existing product registrations, regulatory submissions, foreign countries registrations, certificates, etc.
  • Reviews, evaluates and approves plant operating documents such as SOPs, change control, qualification reports, Protocols, CAPA, and process deviation investigations and maintains documents in an organized and traceable manner.
  • Evaluates specifications, documents, protocols, registrations and recommends actions to assure regulatory compliance.
  • Provides assistance in managing all aspects of regulatory and corporate inspections and participates actively during inspections and audits including performing readiness exercises before and during inspections/audits.
  • Evaluates and recommends lots to be placed on stability, evaluate trends, and performs investigations when required.
  • Ensures compliance with procedures, policies and directives to avoid regulatory issues performing Gap Analysis on BMS documents and observational findings from the pharmaceutical industry.
  • Provides advice and service to all operating departments to assure compliance with cGMP’s and other regulations.
  • Investigates customer complaints, issues the corresponding reports indicating possible root cause and recommending solutions.
  • Conducts and/or prepares training materials on GMP topics.
  • Performs formal internal audits and pre-approval inspections at manufacturing, laboratory, utilities and warehouse operations for cGMP’s compliance. Prepares reports and follow up on observed deficiencies on a regular basis.


Role Requirements:
  • BS degree (Engineering, Pharmacy, Chemistry, Biology).
  • Minimum Five (5) years of experience in the pharmaceutical industry for oral dosage manufacturing.
  • Broad knowledge of cGMP governmental regulations and guidelines, and the ability to interpret and apply them.
  • Ability to communicate effectively with wide range of personnel, written and verbal.
  • Fully bilingual (Spanish/English) writing and speaking.
  • Solid technical writing and interpretation skills related to investigations, process & equipment validations/qualifications, computer system validations, Regulatory Filings, and customer complaints.
  • Ability to create / organize cGMP systems and procedures based on regulatory compliance requirements.
  • Knowledge to conduct and lead GMP Audits (internal and external) and regulatory inspections.
  • Computer skills (require using computerized systems).
  • Handle multiple tasks and comply with agreed or established completion due dates.
  • Quality Certifications by recognized organizations is highly desirable.


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.

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 any part of the recruitment process direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

R1546283-en-us