Process Quality Excellence 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.
The Role:
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 studiesAudit Coordination:
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 closureYour Background:
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 essentialApply:
Please send your CV and cover letter in English. It is essential that applicants hold entitlement to work in the UK. Please quote job reference (phone number removed)in all correspondence