Quality Specialist

NextLink Group; Slough; On-site; GBP 70,000 - 90,000; Full time

Job summary

NextLink Group in Slough, UK, seeks a Senior Process Quality Excellence Specialist to strengthen the quality framework supporting global clinical study operations. You will drive inspection readiness, audits, and CAPA activities within the GCSO Quality Management System.

You will collaborate with Global Quality, Regulatory Affairs, clinical teams, and external stakeholders to prepare and support audit findings and CAPA closures, reporting to the Head of Process Quality Excellence.

Qualifications

• Bachelor's degree or equivalent relevant 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.
• In-depth knowledge of GCP, ICH guidelines, and relevant international and local regulations for clinical study operations.
• Hands-on experience supporting or leading global GCP audits, inspections, inspection readiness, responses, and CAPA activities.
• 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.

Responsibilities

• Lead and drive GCSO Inspection Readiness Activities across all GCSO functions working closely with the relevant inspection team(s), if applicable.
• Participate in Audit and Inspection planning with Global Quality.
• Act as audit host for GCSO Internal Audits, if applicable.
• Represent or ensure GCSO representation including preparation during audits/inspections (on-site at UCB by internal and external parties) as applicable.
• Support GCSO staff with audit/inspection responses, where required.
• Support Corrective and Preventive Action (CAPA) activity for internal (system) audits and findings from any audits and inspections where findings are raised to UCB in conjunction with department managers and subject matter experts. This includes CAPA tracking and monitoring for timely closure.

Education

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

Eight years of pharmaceutical experience

GCP/ICH regulatory knowledge

CAPA experience

SOP writing/revising

Excellent English communication

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.