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