REMS Audit 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.

Functional Area Description

The Worldwide Patient Safety (WWPS) group is responsible for ensuring the safety of our medicines. WWPS pharmacovigilance and pharmacoepidemiology deliverables include single case and aggregate safety monitoring, safety reporting, contributing to benefit-risk assessment, risk management planning and strategy, execution of certain postmarketing commitments, and ensuring compliance with global regulatory requirements.

Summary:

The selected candidate will be responsible for performing external REMS quality audits for 1 or more REMS programs. External audits are performed to assess compliance with Celgene standards and applicable regulatory requirements.

Key Activities
  • Performs US REMS quality audits and associated tasks for one or more REMS programs according to established policies, SOPs, WPs, standards, templates, etc.
  • Manages time and travel: works independently, adheres to audit processes timeline requirements and works with auditees to help them adhere to audit process timelines.
  • Organizes and schedules assigned audits
  • Conducts on-site audits
  • Provides auditees guidance on developing Corrective/Preventive Action Plans and Effectiveness Checks.
  • Writes and issues audit reports and other audit-related documents.
  • Escalates audit-related issues appropriately.
  • Enters audit data and works in electronics systems according to established procedures and timelines.
  • Contributes expertise to improving electronic systems, and revising audit standards, procedures, templates, etc.
  • Prepares and delivers audit-related presentations to auditees and internal stakeholders
  • Acts as the key point of contact for audit-related issues for assigned external multi-location organizations.
  • Maintains an effective working relationship with internal stake-holders, including Account Management.


Qualifications
  • B.S. or B.S./M.S. in Chemistry, Nursing, Biology, or other related fields.
  • An American Quality Society (ASQ) Certified Quality Auditor (CQA) certification is preferred.
  • +60% travel required
  • 5 years of diverse pharmaceutical experience with 1 - 3 years of auditing experience, or diverse experience with FDA regulations and quality systems in the pharmaceutical industry or demonstrates required skills and knowledge.
  • Performs duties with minimal supervision.
  • Well-developed communication skills (verbal and written) with the ability speak in front of internal/external groups. Possesses a high level of maturity and character


Knowledge
  • Current knowledge of applicable regulations from FDA and international agencies
  • Current knowledge Risk management environments preferred


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.

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