Senior Director GCP GLP Quality Assurance

The Senior Director, GCP/GLP Quality Assurance role at the client involves leading the Clinical Quality strategy, ensuring alignment with regulatory standards, managing quality programs and audits, and providing compliance guidance for clinical and non-clinical development. Responsibilities include developing a Clinical Quality strategy in line with organizational goals and regulatory standards, implementing an audit strategy for studies, and offering compliance advice to clinical study teams for quality improvement. The role also involves evaluating and selecting service providers and securing Quality Agreements for compliance.To qualify for this position, candidates must have a Bachelor's degree in life sciences and over 15 years of experience in the biopharmaceutical field. They should be knowledgeable in FDA, EU, and ICH regulations, particularly in early-phase trials, and have experience in managing GCP inspections, with BIMO inspection experience preferred. Strong skills in building cross-functional partnerships to meet strategic goals and proficiency in creating compliance strategies are also required for this role at the client.Overall, the Senior Director, GCP/GLP Quality Assurance role at the client is a key position that involves developing and implementing a Clinical Quality strategy, managing quality programs and audits, and providing compliance guidance for clinical and non-clinical development. Candidates should have extensive experience in the biopharmaceutical field, strong knowledge of regulatory standards, and the ability to build partnerships to achieve strategic goals.

Created: 2025-02-10