Senior Process Quality Excellence Specialist
Posted 2 days ago 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 a 12-month contract. The role involves managing Regulatory Intelligence requirements for Global Clinical Safety Operations and coordinating with subject matter experts (SMEs) on regulatory compliance. The position requires a strong background in QA or Clinical Operations and GCP experience, with a commitment to working onsite in Slough two days a week.
Key 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.
Key Skills:
- Regulatory Intelligence experience required.
- QA or Clinical Operations background preferred.
- GCP experience necessary.
- Willingness to work onsite in Slough 2 days per week.
- Full-time role.
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 bring comprehensive Regulatory Intelligence experience and will successfully manage the RIN requirements for Global Clinical Safety Operations.
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
- GCP experience necessary
- Willingness to work onsite in Slough 2 days per week
- Full-time role
- Competitive hourly rates