Director of Drug Safety Operations
2 months ago
CK Group are recruiting for a contract Drug Safety Director to join a company in the healthcare and pharmaceutical industry at their site based in Staffordshire on a contract basis.
**The Location**:
The role is based at our client's site in Burton 3 days per week.
**The Role**:
The main purpose of the role will be to
- Lead the strategic direction and management of GxP regulatory activities of the UK and EU
- Act as the Responsible Person for UK and Netherlands to support the maintenance of licensed operations, by ensuring compliance with regulatory requirements.
- Ensure compliance with all regulatory requirements are fulfilled and any deviations or breach is addressed immediately
**Further responsibilities will include**:
- Ensuring quality management processes are in place and used effectively
- Providing regulatory support for country specific Early Access Programs (EAPs).
- Overseeing external audits, including regulatory inspections and client audits, in relation to licensed operations
**Your Background**:
To succeed in this role, you will come from a background in Life Sciences, with considerable Drug Safety experience.
- Demonstrates a sound understanding of GxP regulations
- Experience in leading and managing a team
- Experience in a clinical quality or governance related role
**Apply**:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 54823 in all correspondence.
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