Process Quality Excellence Specialist

Job description

About the Role

This is a dual-focused clinical quality role combining Audit Hosting and Regulatory Intelligence (RIN) coordination within a global clinical sciences and operations environment. The role acts as a central point of contact between Quality Assurance, internal SMEs and external partners to ensure clinical quality systems remain inspection-ready and aligned with evolving GCP regulatory requirements. You will coordinate internal audits, support audit follow-up activities including CAPAs and manage regulatory intelligence updates impacting controlled documents across the organisation.

About the Company

You will be joining a global, science-driven biopharmaceutical organisation committed to advancing innovative medicines that make a meaningful difference to patients’ lives. With a strong focus on quality, compliance and collaboration, the company operates across international markets and partners closely with CROs and regulatory authorities to deliver high-quality clinical research in line with global standards.

Key Responsibilities

• Act as Audit Host for internal quality audits, serving as the primary coordinator between the auditing team and relevant internal SMEs
• Prepare for audits by coordinating document requests, scheduling meetings and ensuring stakeholder readiness
• Support SMEs during audits by facilitating responses to auditor queries
• Coordinate post-audit activities, including responses to findings, CAPAs and follow-up actions through to audit closure
• Act as Regulatory Intelligence (RIN) Coordinator for the Global Clinical Sciences and Operations group
• Monitor changes in GCP regulations, guidance and country-specific requirements impacting clinical operations
• Perform high-level gap assessments to determine impact on existing SOPs and controlled documents
• Identify and assign appropriate SMEs to review and update documentation based on regulatory changes
• Coordinate document updates, track timelines and actively chase stakeholders to ensure on-time completion
• Act as a point of contact to confirm CROs have assessed regulatory and country requirements that may impact their SOPs and company-sponsored studies

Requirements

• 3–5 years’ experience within Clinical Quality in a pharma or CRO environment
• Strong GCP background with hands-on experience in GCP clinical trials, audits or inspections
• Experience supporting audits, including document provision and CAPA management
• Clear understanding of quality systems within clinical development (GCP only – GMP/GLP experience not suitable)
• Experience with Regulatory Intelligence, regulatory surveillance or gap analysis is highly desirable
• Alternatively, experience in Regulatory Intelligence with some exposure to GCP audits will be considered
• Strong coordination, stakeholder management and follow-up skills
• Confident working with SMEs to interpret regulations and translate requirements into document updates
• Comfortable working in a hybrid environment and managing multiple priorities

Extra information

Status

Open

Education Level

Secondary School

Location

Slough

Type of Contract

Full-time jobs

Published at

05-02-2026

Full UK/EU driving license preferred

No

Car Preferred

No

Must be eligible to work in the EU

No

Cover Letter Required

No

Languages

English