Lee Fletcher

Executive Director Quality Assurance @Replimune

Didcot, GB

Provide Replimune management to Qualified Person(s) who fulfil duties in compliance with EU and UK Annex 16Oversees compliance and manufacturing QA for the UK and EU, functions ensuring the establishment, implementation and maintenance of Quality Management Systems (QMS) in accordance with applicable standards established by FDA, MHRA, and other regulatory bodies.Ensures that GXP systems are inspection ready and manages inspection readiness activities.Oversees and provides direction for the Quality Assurance staff and ensures QA release, compliance and documentation functions are performed effectively. Interfaces with internal customers in Research, Product Development, Quality Control and Operations. Oversees and facilitates Replimune’s QA interactions with external vendors such as contract manufacturing organizations, and other service providers to ensure compliance with Replimune requirements and GXP quality standards. Provides support to Chemistry & Manufacturing Controls (CMC) regulatory activities, to facilitate regulatory approval of the Company’s products. Oversee Replimune compliance and Quality systems: audits, vendor qualification, change control, deviation and investigation management, corrective and preventive action systems, QC release testing.Oversees batch review of Replimune clinical and commercial products.Execute batch disposition of Replimune clinical and commercial products.

University of Portsmouth

Bachelor's Degree, Biology, General