Hybrid: Senior GCP Quality & Audit Readiness Lead

UCB S.A.; Princes Risborough; Hybrid; GBP 70,000 - 110,000; Full time

Job summary

UCB S.A. is seeking a Senior Process Quality Excellence Specialist to reinforce the quality framework across global clinical study operations from our Slough, UK offices (moving to Windlesham in 2027).

You will lead GCP inspection readiness, guide teams through regulatory inspections, and maintain the audit enabler within the GCSO Quality Management System, reporting to the Head of Process Quality Excellence.

Qualifications

• Bachelor's degree or equivalent relevant GCP experience in life sciences, quality, clinical research, or a related field.
• At least eight years of pharmaceutical experience, preferably in global quality assurance, clinical quality management, or clinical operations.
• Experience writing and revising SOPs, with strong planning, investigation, and root-cause analysis skills.
• Clear written and spoken English, with the ability to explain complex topics across cultures and seniority levels.

Responsibilities

• Lead and support GCP inspection readiness activities across all GCSO functions with the inspection team(s).
• Host internal GCP audits and assist with audit planning alongside Global Quality.
• Assist in preparing timely, clear, evidence-based audit and inspection responses.
• Support CAPA activities arising from audits or inspections, including CAPA tracking and timely closure.

Skills

GCP knowledge

ICH guidelines

CAPA management

SOP writing

Audit coordination

English communication

Education

Bachelor's degree or equivalent relevant GCP experience in life sciences, quality, clinical research, or a related field

Job description

UCB S.A. is seeking a Senior Process Quality Excellence Specialist to reinforce the quality framework across global clinical study operations from our Slough, UK offices (moving to Windlesham in 2027).

You will lead GCP inspection readiness, guide teams through regulatory inspections, and maintain the audit enabler within the GCSO Quality Management System, reporting to the Head of Process Quality Excellence.