Senior Quality Coordinator

We are seeking a professional with Regulatory Intelligence experience to support global compliance activities within a regulated environment. This role will serve as the central coordinator for regulatory intelligence requirements, ensuring regulatory and guidance changes are assessed, assigned, and managed in collaboration with subject matter experts (SMEs). The position also includes acting as an Audit Host and primary liaison for internal quality audits.

This is a 12 month contract with high likelihood of extension. It is a hybrid position (2 days onsite in the Berkshire area and 3 days WFH).

Key Responsibilities:

Regulatory Intelligence & Compliance Coordination

• Serve as the Regulatory Intelligence (RIN) Coordinator, overseeing regulatory intelligence requirements and workflows.
• Review new and updated regulations, guidance, and country-specific requirements, and determine applicability to internal processes and controlled documents.
• Identify and assign appropriate SMEs based on regulatory topic and area of expertise.
• Coordinate with internal stakeholders to ensure timely assessment and implementation of regulatory and guidance changes.
• Act as a primary point of contact to confirm that external partners (e.g., CROs) have assessed relevant regulatory and country requirements that may impact their standard operating procedures (SOPs) and associated studies.

Audit Hosting & Quality Support

• Act as an Audit Host for internal quality audits, working closely with the internal auditing team.
• Coordinate audit logistics, including scheduling, documentation, and communication with relevant SMEs and functional groups.
• Support SMEs during audits by facilitating responses to auditor inquiries and ensuring timely provision of requested information.
• Serve as the main liaison between auditors and auditees throughout the audit lifecycle.
• Support post-audit activities by coordinating responses to audit findings, corrective and preventive actions (CAPAs), and follow-up activities until audit closure.

Qualifications & Experience

• Experience in Regulatory Intelligence, regulatory compliance, or a related quality/regulatory function within a regulated industry.
• Strong understanding of global regulatory frameworks and guidance interpretation.
• Proven ability to review regulations and assess applicability across functional areas.
• Experience supporting or coordinating internal audits in a quality environment.
• Strong organizational, coordination, and stakeholder management skills.
• Excellent written and verbal communication skills.
• Ability to work cross-functionally with SMEs, auditors, and external partners.