Global Quality & Regulatory Compliance, Clinical Trials & Safety
(Senior Compliance Auditing Manager)
GQRC-CT&S is responsible for auditing all processes related to clinical research including specific medical affairs processes, and pharmacovigilance activities, to assess compliance with relevant regulations and applicable policies and procedures. This includes investigator site, internal systems (e.g. REMS), and external vendor audits. It is also responsible for management of regulatory agency inspections and for providing advice on regulatory requirements.
Purpose/Objective of the job:
To conduct Good Clinical Practice (GCP) and pharmacovigilance (PV) audits.
To act as project-specific liaison between GQRC-CT&S and key stakeholders, including Global Development Operations and Global Regulatory & Safety Sciences personnel, monitoring the status of the project(s) to plan audits and assuring GQRC-CT&S leadership is informed.
Key Responsibilities and Major Duties:
- Perform GCP audits of investigator sites, vendors and internal systems.
- Act as lead auditor, develop the audit plan and determine priorities for the audit. Prioritize and focus on matters of significance.
- Collect information through effective interviewing, listening, observing and reviewing documents, records and data.
- Maintain an in-depth knowledge of governmental regulations, which impact the research and development of medicines, as well as the most relevant Bristol-Myers Squibb Company policies, directives, and procedures related to clinical research.
- Manage health authority inspections and/or review of findings, and make recommendations for corrective and preventative action.
- Provide advice and counsel concerning GCP-related regulatory requirements.
- As appropriate, represent BMS within trade and professional associations.