Senior Process Quality Excellence Specialist

Overview

Own the audit journey—from preparation to closure with excellence. Proclinical is seeking a Senior Process Quality Excellence Specialist to support regulatory intelligence and quality excellence initiatives within the neurology and biotechnology space. This role focuses on managing regulatory guidance requirements, coordinating with subject matter experts (SMEs), and ensuring compliance with controlled documents. Additionally, you will act as a key point of contact for audits, working closely with auditing teams and SMEs to facilitate smooth processes and address findings.

• Serve as the RIN (Regulatory Intelligence Network) coordinator, managing regulatory guidance requirements for GCSO.
• Collaborate with SMEs to review regulations and assign responsibilities based on specific topics.
• Act as a liaison to confirm that CROs have assessed regulatory and country-specific regulations impacting their SOPs and studies.
• Host and coordinate internal quality audits in collaboration with the auditing team and relevant SMEs.
• Assist SMEs during audits by responding to queries and facilitating communication with auditees.
• Support post-audit activities, including addressing findings, developing CAPAs, and ensuring audit closure.

• Strong experience in regulatory intelligence and quality management.
• Ability to review and interpret regulations and assign responsibilities effectively.
• Excellent coordination and communication skills to work with cross-functional teams and SMEs.
• Familiarity with audit processes, including hosting, query resolution, and post-audit follow-up.
• Detail-oriented with a focus on compliance and process improvement.

For inquiries, contact Peter Duvall at .

To apply, click "Apply" or request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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