Senior Process Quality Excellence Specialist
Posted Today by Warman O'Brien
Negotiable
Undetermined
Hybrid
Slough, England, United Kingdom
Summary: A global pharmaceutical company is seeking a Senior Process Quality Excellence Specialist for an initial 12-month contract. The role involves coordinating regulatory intelligence and supporting quality audits within a growing team. The position requires collaboration with subject matter experts (SMEs) and oversight of regulatory compliance in clinical studies. The candidate must be willing to work onsite in Slough two days a week.
Key Responsibilities:
- Become the Regulatory Intelligence coordinator to work with relevant SMEs for regulatory/guidance requirements to controlled documents.
- Review regulations and identify which SMEs should be assigned based on the topic.
- Act as a point of contact to confirm that CROs have assessed regulatory and country regulations that may impact their SOPs and clinical studies.
- Act as Audit Host - work with the Auditing team to host and coordinate with relevant SMEs and functions on any internal Quality Audit.
- Act as a point of contact and co-ordinator with the auditing team.
- During the audit, assist the assigned SMEs in responding to queries by the auditees.
- Post-audit, work with the SMEs on responses to findings, CAPAs, etc., until the audit is closed.
Key Skills:
- Regulatory Intelligence experience required.
- QA or Clinical Operations background preferred.
- Willingness to work onsite in Slough 2 days per week.
Salary (Rate): undetermined
City: Slough
Country: United Kingdom
Working Arrangements: hybrid
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
A global pharmaceutical company is looking to hire a Senior Process Quality Excellence Specialist on an initial 12 month contract. Working on global study specific activities within a growing team, you will have the following responsibilities:
- Become the Regulatory Intelligence coordinator to work with the relevant SMEs for regulatory/guidance requirements to controlled documents
- Review regulations and identify which SMEs should be assigned based on the topic
- Act as a point of contact to confirm that CROs have assessed regulatory and country regulations that may impact their SOPs and clinical studies
- Act as Audit Host - work with the Auditing team to host and coordinate with relevant SMEs and functions on any internal Quality Audit
- Act as a point of contact and co-ordinator with the auditing team
- During the audit, assist the assigned SMEs in responding to queries by the auditees.
- Post-audit, work with the SMEs on responses to findings, CAPAs, etc., until the audit is closed.
Additional information: Regulatory Intelligence experience required QA or Clinical Operations background preferred Willingness to work onsite in Slough 2 days per week Full-time role Competitive hourly rates