Global Audit & Quality Excellence Lead

Next-Link; Slough; On-site; GBP 65,000 - 95,000; Full time

Job summary

Next-Link in Slough, United Kingdom, seeks a Senior Process Quality Excellence Specialist to strengthen the quality framework for global clinical study operations. You will support audits, inspections, and CAPA activities within the GCSO Quality Management System.

Ideal candidates have 8+ years in pharma quality assurance or clinical operations, strong GCP knowledge, and experience in SOPs and cross-functional collaboration across global teams.

Qualifications

• Bachelor's degree or equivalent in life sciences, quality, clinical research, or related field.
• Eight years of pharmaceutical experience, preferably in global quality assurance or clinical operations.
• In-depth knowledge of GCP, ICH guidelines, and relevant regulations for clinical study operations.
• Hands-on experience supporting or leading global GCP audits, inspections, and CAPA activities.
• At least one year of experience writing and revising SOPs with planning, investigation, and root-cause analysis.
• Clear written and spoken English with ability to collaborate across cultures and seniority levels.

Responsibilities

• Lead and drive 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 or ensure GCSO representation during audits/inspections (on-site at UCB where applicable).
• Support GCSO staff with audit/inspection responses.
• Support CAPA activity for internal audits and findings, including CAPA tracking and timely closure.

Skills

GCP knowledge

CAPA tracking

Root-cause analysis

Audit & Inspection readiness

SOP writing

Cross-cultural collaboration

English communication

Education

Bachelor's degree or equivalent in life sciences/quality/clinical research

Job description

Next-Link in Slough, United Kingdom, seeks a Senior Process Quality Excellence Specialist to strengthen the quality framework for global clinical study operations. You will support audits, inspections, and CAPA activities within the GCSO Quality Management System.

Ideal candidates have 8+ years in pharma quality assurance or clinical operations, strong GCP knowledge, and experience in SOPs and cross-functional collaboration across global teams.