Process Quality Excellence Specialist
Listed on 2026-02-22
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist
Location: Berkshire (2 days in the office – Tuesday/Thursday)
Contract: 12-month contract
Rate: Up to £47.92 using an umbrella company
CK Group are recruiting on behalf of a global pharmaceutical company specialising in the discovery, development, and commercialisation of medicines for severe diseases within neurology and immunology.
This is a 12-month contract opportunity for a Process Quality Excellence Specialist
, supporting the Global Clinical Safety Operations (GCSO) function.
This is a hands‑on, coordination‑focused quality role, suited to someone comfortable working across audits, regulatory intelligence, and cross‑functional stakeholders. The successful candidate will act as a key point of contact for both regulatory intelligence notifications (RIN) and internal quality audits.
Key Responsibilities Regulatory Intelligence & RIN Coordination- Act as the RIN Coordinator for GCSO, managing Regulatory Intelligence Notifications and associated actions
- Review new and updated regulations and guidance, assessing impact on controlled documents
- Identify and assign appropriate Subject Matter Experts (SMEs) based on regulatory topics
- Track actions and timelines, ensuring follow‑up and completion
- Act as a point of contact to confirm CRO assessment of regulatory and country‑specific requirements impacting SOPs and clinical studies
- Act as Audit Host for internal quality audits
- Coordinate with the internal Auditing team and relevant SMEs and functions
- Prepare for audits, manage documentation requests, and track timelines
- Support SMEs during audits by coordinating responses to auditor queries
- Manage post‑audit activities including findings, CAPAs, and follow‑up actions through to audit closure
- Experience in Regulatory Intelligence, RIN coordination, or regulatory compliance within a GxP environment
- Prior involvement in quality audits, either as an audit host or audit support function
- Strong understanding of GCP and clinical research regulatory requirements
- Excellent organisational, coordination, and communication skills
- Ability to work across multiple stakeholders and manage timelines effectively
- QA background welcomed but not essential
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).