Quality Specialist

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

Slough, United Kingdom | Posted on 09/18/2026

We are looking for a Senior Process Quality ExcellenceSpecialist who is collaborative, analytical, and quality-focused to joinour Global Clinical Sciences and Operations team, based in our Slough,UK offices.

About the role

You will help strengthen the quality framework that supportsglobal clinical study operations with the role focusing on supporting the GCSOfunctions with audits and inspections. You are going to report to the Head ofProcess Quality Excellence and maintain the audit and inspection enabler withinthe GCSO Quality Management System.

Who you’ll work with

You will work within Global Clinical Sciences and Operationsfunctional teams and collaborate across Global Quality, Regulatory Affairs,clinical teams, strategic partners, and other internal and externalstakeholders. You are going to share guidance, build effective workingrelationships, and bring the right people together to prepare, participate andsupport the resolution of any audit and inspection findings and subsequentCAPA’s. You will represent GCSO in audit and inspection discussionsand be the first point of contact for GCSO colleagues.

What you’ll do

• Leadand drive GCSO Inspection Readiness Activities across all GCSO functionsworking closely with the relevant inspection team(s), if applicable.
  
• Participatein Audit and Inspection planning with Global Quality.
  
• Actas audit host for GCSO Internal Audits, if applicable.
  
• Representor ensure GCSO representation including preparation duringaudits/inspections (on-site at UCB by internal and external parties) asapplicable.
  
• SupportGCSO staff with audit/inspection responses, where required.
  
• SupportCorrective and Preventive Action (CAPA) activity for internal (system)audits and findings from any audits and inspections where findings areraised to UCB in conjunction with department managers and subject matterexperts. This includes CAPA tracking and monitoring for timely closure.
  

Requirements

• Bachelor'sdegree or equivalent relevant experience in life sciences, quality,clinical research, or a related field.
  
• Atleast eight years of pharmaceutical experience, preferably in globalquality assurance, clinical quality management, or clinical operations.
  
• In-depthknowledge of GCP, ICH guidelines, and relevant international and localregulations for clinical study operations.
  
• Hands-onexperience supporting or leading global GCP audits, inspections,inspection readiness, responses, and CAPA activities.
  
• Atleast one years of experience writing and revising SOPs, with strongplanning, investigation, and root-cause analysis skills.
  
• Clearwritten and spoken English, with the ability to explain complex topics andcollaborate effectively across cultures, functions, and seniority levels.