Process Quality Excellence Specialist

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 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

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 173257in all correspondence.