Senior Process Quality Excellence Specialist

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

Make your mark for patients

We are looking for a Senior Process Quality Excellence Specialist who is collaborative, analytical, and quality-focused to join our Global Clinical Sciences and Operations (GCSO) team, based in our Slough, UK offices (moving to Windlesham in April 2027).

About the role

You will help strengthen the quality framework that supports global clinical study operations, with a primary focus on hosting internal GCP audits, guiding GCSO teams through GCP regulatory inspections and driving ongoing inspection readiness. You are going to report to the Head of Process Quality Excellence and maintain the audit and inspection enabler within the GCSO Quality Management System.

Who you'll work with

You will work within Global Clinical Sciences and Operations functional teams including GCSO leadership and collaborate with other functional stakeholders such as Global Quality Regulatory Affairs and other internal and external stakeholders. You are going to share guidance, build effective working relationships, and bring the right people together to prepare for and support those participating in internal GCP audits and GCP regulatory inspections, and to support the GCSO team in the resolution of any audit and inspection findings and subsequent CAPA's. You will represent GCSO in audit and inspection discussions and be the first point of contact for GCSO colleagues and Leadership Team.

What you'll do

Lead and drive GCP inspection readiness activities across all GCSO functions working closely with the relevant inspection team(s), as applicable.

• Host internal GCP audits and support internal audit planning with Global Quality which includes preparation and support during the audit.
• Support GCSO staff in preparing clear, timely, and evidence-based audit and inspection responses where required.
• Support Corrective and Preventive Action (CAPA) activities arising from internal system and GCP audits or inspections, in collaboration with department managers and subject matter experts. This includes CAPA tracking and monitoring for timely closure.

Interested?

For this position you'll need the following education, experience and skills:

• 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 supporting clinical study knowledge of GCP, ICH guidelines, and relevant international and local regulations governing clinical study experience supporting or leading global GCP audits, regulatory inspections, inspection readiness activities, inspection responses, and related CAPA activities within a clinical research or clinical development environment.
• At least one year of 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 and collaborate effectively across cultures, functions, and seniority levels.

Are you ready to 'go beyond' to create value and make your mark for patients?

If this sounds like you, then we would love to hear from you!

About us

UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are over 9.000 people in all four corners of the globe, inspired by patients and driven by science. Why work with us? At UCB, we don't just complete tasks, we create value. We aren't afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equal opportunities to do their best work. We 'go beyond' to create value for our patients, and always with a human focus, whether that's on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential. At UCB, we've embraced a hybrid-first approach to work, bringing teams together in local hubs to foster collaborative curiosity. Unless expressly stated in the description or precluded by the nature of the position, roles are hybrid with 40% of your time spent in the office.

UCB is an equal opportunity employer.

All employment decisions will be made without regard to any characteristic protected by applicable laws.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.

Job Summary

Job number: 93898

Date posted : Profession: Quality & Patient SafetyEmployment type: Permanent