Process Quality Excellence Specialist
Posted 5 days ago by Planet Pharma
Negotiable
Undetermined
Hybrid
Slough, England, United Kingdom
Summary: This role is a dual-focused clinical quality position that combines Audit Hosting and Regulatory Intelligence coordination within a global clinical sciences environment. The specialist will act as a liaison between Quality Assurance, internal subject matter experts (SMEs), and external partners to maintain inspection readiness and compliance with evolving GCP regulations. Responsibilities include coordinating internal audits, managing regulatory intelligence updates, and ensuring documentation aligns with regulatory changes. The position is based in a science-driven biopharmaceutical organization committed to high-quality clinical research.
Key Responsibilities:
- Act as Audit Host for internal quality audits, serving as the primary coordinator between the auditing team and relevant internal SMEs
- Prepare for audits by coordinating document requests, scheduling meetings and ensuring stakeholder readiness
- Support SMEs during audits by facilitating responses to auditor queries
- Coordinate post-audit activities, including responses to findings, CAPAs and follow-up actions through to audit closure
- Act as Regulatory Intelligence (RIN) Coordinator for the Global Clinical Sciences and Operations group
- Monitor changes in GCP regulations, guidance and country-specific requirements impacting clinical operations
- Perform high-level gap assessments to determine impact on existing SOPs and controlled documents
- Identify and assign appropriate SMEs to review and update documentation based on regulatory changes
- Coordinate document updates, track timelines and actively chase stakeholders to ensure on-time completion
- Act as a point of contact to confirm CROs have assessed regulatory and country requirements that may impact their SOPs and company-sponsored studies
Key Skills:
- 3–5 years’ experience within Clinical Quality in a pharma or CRO environment
- Strong GCP background with hands-on experience in GCP clinical trials, audits or inspections
- Experience supporting audits, including document provision and CAPA management
- Clear understanding of quality systems within clinical development (GCP only – GMP/GLP experience not suitable)
- Experience with Regulatory Intelligence, regulatory surveillance or gap analysis is highly desirable
- Alternatively, experience in Regulatory Intelligence with some exposure to GCP audits will be considered
- Strong coordination, stakeholder management and follow-up skills
- Confident working with SMEs to interpret regulations and translate requirements into document updates
- Comfortable working in a hybrid environment and managing multiple priorities
Salary (Rate): undetermined
City: Slough
Country: United Kingdom
Working Arrangements: hybrid
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
About the Role This is a dual-focused clinical quality role combining Audit Hosting and Regulatory Intelligence (RIN) coordination within a global clinical sciences and operations environment. The role acts as a central point of contact between Quality Assurance, internal SMEs and external partners to ensure clinical quality systems remain inspection-ready and aligned with evolving GCP regulatory requirements. You will coordinate internal audits, support audit follow-up activities including CAPAs and manage regulatory intelligence updates impacting controlled documents across the organisation.
About the Company You will be joining a global, science-driven biopharmaceutical organisation committed to advancing innovative medicines that make a meaningful difference to patients’ lives. With a strong focus on quality, compliance and collaboration, the company operates across international markets and partners closely with CROs and regulatory authorities to deliver high-quality clinical research in line with global standards.
Key Responsibilities
- Act as Audit Host for internal quality audits, serving as the primary coordinator between the auditing team and relevant internal SMEs
- Prepare for audits by coordinating document requests, scheduling meetings and ensuring stakeholder readiness
- Support SMEs during audits by facilitating responses to auditor queries
- Coordinate post-audit activities, including responses to findings, CAPAs and follow-up actions through to audit closure
- Act as Regulatory Intelligence (RIN) Coordinator for the Global Clinical Sciences and Operations group
- Monitor changes in GCP regulations, guidance and country-specific requirements impacting clinical operations
- Perform high-level gap assessments to determine impact on existing SOPs and controlled documents
- Identify and assign appropriate SMEs to review and update documentation based on regulatory changes
- Coordinate document updates, track timelines and actively chase stakeholders to ensure on-time completion
- Act as a point of contact to confirm CROs have assessed regulatory and country requirements that may impact their SOPs and company-sponsored studies
Requirements
- 3–5 years’ experience within Clinical Quality in a pharma or CRO environment
- Strong GCP background with hands-on experience in GCP clinical trials, audits or inspections
- Experience supporting audits, including document provision and CAPA management
- Clear understanding of quality systems within clinical development (GCP only – GMP/GLP experience not suitable)
- Experience with Regulatory Intelligence, regulatory surveillance or gap analysis is highly desirable
- Alternatively, experience in Regulatory Intelligence with some exposure to GCP audits will be considered
- Strong coordination, stakeholder management and follow-up skills
- Confident working with SMEs to interpret regulations and translate requirements into document updates
- Comfortable working in a hybrid environment and managing multiple priorities