Job Description

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

TMC Pharma Services Ltd jobs

Quality Assurance Manager