Senior Process Quality Excellence Specialist
Posted 1 day ago by MSI Pharma
£55 Per hour
Inside
Hybrid
Slough, England, United Kingdom
Summary: The Senior Process Quality Excellence Specialist role is a twelve-month contract position within a global biopharma organization, focusing on maintaining clinical quality systems and ensuring compliance across global clinical programs. The position requires collaboration with various stakeholders to develop quality systems and support audit readiness. The role demands extensive experience in GCP, GLP, and PV regulations. This hybrid role is based in Slough, England.
Key Responsibilities:
- Support the Head of Process Quality Excellence with development of quality and compliance infrastructure and contribute to creation and revision of policies, SOPs, processes and best practices.
- Collaborate with Global Quality, Patient Safety, Regulatory Affairs, strategic partners and wider stakeholders to ensure compliance with ICH GCP, GLP, PV and international regulations.
- Lead inspection readiness initiatives across all GCSO functions in partnership with inspection teams.
- Contribute to audit and inspection planning with Global Quality.
- Represent GCSO or support teams with preparation and participation in internal and external audits and inspections.
- Support GCSO staff with responses to audit and inspection findings where required.
Key Skills:
- 8+ years of pharmaceutical experience ideally within global Quality Assurance or Clinical Development.
- Strong experience across GCP and GVP with hands on involvement in global GCP audits and inspections.
- 2+ years of experience writing SOPs.
Salary (Rate): £55.00/hr
City: Slough
Country: United Kingdom
Working Arrangements: hybrid
IR35 Status: inside IR35
Seniority Level: Senior
Industry: Other
Senior Process Quality Excellence Specialist Initial twelve month contract inside IR35 Hybrid role. Current location Slough. I am supporting a global biopharma organisation with the hire of a Senior Process Quality Excellence Specialist for an initial twelve month contract inside IR35. The role sits within Global Clinical Sciences and Operations and is focused on maintaining robust clinical quality systems, mitigating compliance risks and ensuring strong inspection readiness across global clinical programmes.
The opportunity You will partner closely with the Head of Process Quality Excellence to develop and maintain quality systems and procedures across GCSO. This includes shaping policies, SOPs, processes and best practices, as well as supporting teams before and during audits and inspections. The role spans all areas of clinical studies managed by GCSO and requires deep experience across GCP, GLP and PV regulations.
- Key responsibilities
- Support the Head of Process Quality Excellence with development of quality and compliance infrastructure and contribute to creation and revision of policies, SOPs, processes and best practices.
- Collaborate with Global Quality, Patient Safety, Regulatory Affairs, strategic partners and wider stakeholders to ensure compliance with ICH GCP, GLP, PV and international regulations.
- Lead inspection readiness initiatives across all GCSO functions in partnership with inspection teams.
- Contribute to audit and inspection planning with Global Quality.
- Represent GCSO or support teams with preparation and participation in internal and external audits and inspections.
- Support GCSO staff with responses to audit and inspection findings where required.
What you need to bring
- 8+ years of pharmaceutical experience ideally within global Quality Assurance or Clinical Development.
- Strong experience across GCP and GVP with hands on involvement in global GCP audits and inspections.
- 2+ years of experience writing SOPs.
Important information This is a hybrid position. The current office location is Slough and this will remain in place until mid 2026. If you would like to discuss this opportunity please feel free to get in touch.