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.
#J-18808-Ljbffr
Quality Specialist in Slough employer: NextLink Group
Join a dynamic and innovative team in Slough, where we prioritise employee growth and development in the field of upstream process sciences. Our collaborative work culture fosters creativity and encourages the use of cutting-edge technologies, providing you with unique opportunities to contribute to groundbreaking biologics research. With a strong commitment to quality and compliance, we offer a supportive environment that values your contributions and promotes continuous improvement.
