Senior Process Quality Excellence Specialist

Overview

In this role you strengthen the global quality framework for clinical study operations, with a focus on audits and inspections within GCSO. You will collaborate across Quality, Regulatory Affairs, and clinical teams to prepare, participate in, and support audit outcomes and CAPA closure. You will act as the GCSO point of contact for audits and drive readiness activities. This position offers meaningful impact by shaping how we maintain high standards across global studies.

Pay / Benefits

• hybrid work model
• equal opportunity employer
• caring and inclusive culture
• opportunity to impact patients
• global collaboration
• location: Slough, UK

Responsibilities

• Lead GCSO Inspection Readiness activities across all GCSO functions
• Participate in Audit and Inspection planning with Global Quality
• Act as audit host for GCSO Internal Audits
• Represent GCSO during audits/inspections and prepare materials
• Support GCSO staff with audit/inspection responses
• Support CAPA activity for internal audits and findings from audits/inspections
• CAPA tracking and monitoring for timely closure

Key requirements

• Eight years of pharmaceutical experience, preferably in global quality assurance, clinical quality management, or clinical operations
• Deep knowledge of GCP, ICH guidelines, and relevant regulations for clinical study operations
• Hands-on experience supporting or leading global GCP audits, inspections, readiness, responses, and CAPA activities
• At least one year of experience writing and revising SOPs with planning, investigation, and root-cause analysis
• Excellent written and spoken English and ability to collaborate across cultures and levels

• Collaborative mindset
• Strong analytical and problem-solving skills
• Effective communication across functions and regions
• GCP audits and inspections
• Audit readiness and CAPA processes
• SOP development and revision

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