Quality Assurance Manager

Role Description

This is a full-time on-site/hybrid role for a Manager of Quality Services based in our stunning headquarters in Hartley Wintney, Hampshire. TMC is a CRO specialising in Rare and Orphan Diseases. As a Manager of Quality Services, you will be a key member of the TMC in-house team reporting to the Associate Director of Quality Assurance.

Essential Skills and Experience

• Strong knowledge of ICH GCP and relevant regulations (EMA, MHRA).
• GCP certification within the last 2 years
• Minimum of 5 years prior experience in an Audit/QA function of the Pharmaceutical/pharmaceutical service Industry (CRO)
• Familiarity with quality systems
• Bachelor’s degree in a related field

Responsibilities

• managing TMC’s Quality Management System,
• for providing QA guidance and oversight to the TMC team and Clients,
• hosting Client audits,
• supporting the delivery of TMCs Internal and Vendor Audit Program and
• for QI and CAPA management.

You will get the opportunity to work on a wide range of quality activities in some very interesting disease/treatment areas, and to further develop your skills.

Other skills

• Other GxP knowledge and experience would be desirable
• Experience of Process Management (authoring, reviewing, approving SOPs and associated controlled documents) would be of benefit
• Experience of FDA regulatory environment desirable
• Experience of requirements of MAH/GMP desirable
• Excellent analytical and problem-solving skills
• Ability to work effectively in cross-functional teams
• Exceptional attention to detail
• Excellent written and verbal communication skills
• Strong organisational and time management skills
• Advanced degree in a related field is a plus