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Senior Process Quality Excellence Specialist

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SRG

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Location:
United Kingdom , Slough

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Category:
-

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Contract Type:
Not provided

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Salary:

40.00 - 47.00 GBP / Hour

Job Description:

We are supporting a global pharma company who are seeking an experienced Senior Process Quality Excellence Specialist to support the development, maintenance, and continuous improvement of clinical quality systems within Global Clinical Sciences & Operations (GCSO). This role plays a key part in ensuring inspection readiness, regulatory compliance, and high‑quality delivery across clinical programmes.

Job Responsibility:

  • Support the creation, revision, and implementation of GCSO quality and compliance policies, SOPs, and processes
  • Collaborate with Global Quality, Patient Safety, Regulatory Affairs, and external partners to ensure compliance with ICH GCP, GLP, PV and global/local regulations
  • Lead and drive inspection readiness activities across GCSO, serving as a central coordinator with inspection teams
  • Represent GCSO during internal and external audits/inspections, supporting preparation and follow‑up activities
  • Act as Regulatory Intelligence (RIN) Coordinator, reviewing regulations, identifying relevant SMEs, and ensuring CROs assess country‑specific regulatory impacts

Requirements:

  • 8+ years' experience in the pharmaceutical industry, ideally within global Quality Assurance or Clinical Development
  • Strong expertise in GCP and GVP, with hands‑on experience in global audits and/or inspections
  • Minimum 2 years' experience writing or revising SOPs
  • Demonstrated ability to interpret regulatory guidance and coordinate SME engagement across functions
  • Excellent communication and stakeholder‑management skills, with experience supporting audits, inspection readiness, and CAPA follow‑up

Additional Information:

Job Posted:
January 09, 2026

Employment Type:
Fulltime
Work Type:
Hybrid work
Job Link Share:

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