Quality Specialist

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 team based in our Slough UK offices.

About the role

You will help strengthen the quality framework that supports global clinical study operations with the role focusing on supporting the GCSO functions with audits and inspections. 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 youll work with

You will work within Global Clinical Sciences and Operations functional teams and collaborate across Global Quality Regulatory Affairs clinical teams strategic partners and other internal and external stakeholders. You are going to share guidance build effective working relationships and bring the right people together to prepare participate and support the resolution of any audit and inspection findings and subsequent CAPAs. You will represent GCSO in audit and inspection discussions and be the first point of contact for GCSO colleagues.

What youll do

• 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.
  

• Bachelors 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 years 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.