Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Global Quality & Regulatory Compliance, Clinical Trials & Safety

(Senior Compliance Auditing Manager)

GQRC-CT&S is responsible for auditing all processed 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.

  List of minimum requirements:

• University Graduate, Life Sciences degree preferred.
• Demonstrates computer literacy and is able to function independently within an environment that relied heavily on technology for information and communication.
• Good understanding of the drug development process.
• Excellent oral and written communication.
• Fluent in English and other languages, as applicable to assigned audit region.
• Sense of diplomacy and discretion.
• Maintains the confidentiality and security of information, data, documents and records.
• Demonstrates commitment to delivering high-quality work product.
• Knowledge of relevant BMS policies and procedures as well as governmental regulations impacting clinical research and development.
• Strong critical thinking to analyse complex situations and discern critical issues and non-compliant situations and to recommend appropriate corrective and preventive actions.
• Software: Microsoft Suite, ESF, Jreview, PRISM, Trackwise CAT, Sharepoint, other systems as assigned/applicable.
• Approximately 25% travel to perform audits and attend professional meetings and seminars.
• Approximately 5 days per month overnight absences required.

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 the resources to pursue their goals, both at work and in their personal lives.