Director of Clinical Audit Strategy
5 days ago
This is a challenging opportunity for an experienced quality assurance professional to join our Research and Development Quality team as Associate Director, Therapeutic Area Quality.
The successful candidate will be responsible for leading the development of the clinical audit strategy and overseeing the planning, conduct, and reporting of internal and external audits of clinical trial investigator sites, vendors, and processes.
The ideal candidate will have a strong background in quality assurance, risk management, and regulatory compliance, with experience in nonclinical/clinical research/pharmacovigilance. They will possess excellent communication and problem-solving skills, with the ability to manage complex assignments/projects and deliver all expected deliverables in a timely manner.
Job Description
- Develop and implement the Clinical Audit Strategy for various Therapy Areas (ICN & HOCT).
- Oversee the planning, conduct, and reporting of internal and external audits of clinical trial investigator sites, vendors, and process/systems.
- Provide input in the global audit plans based on identified signals/trends/risks/gaps.
- Partner with Risk, Governance, Operations (RGO) in the development of the Quality Narrative, specifically developing and contributing to the audit/inspection portion.
About Bristol Myers Squibb
We are a global biopharmaceutical company that focuses on discovering, developing, and delivering innovative therapies for patients with serious diseases. Our mission is to transform patients' lives through science, and we strive to create an inclusive culture that promotes diversity in clinical trials while promoting the highest potential of each colleague.
We are dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments, and ongoing support in their roles.
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