Manager- Quality Assurance, Good Clinical Practice-Auditor Strategy

📋 Description

• • Lead and manage the Good Clinical Practice (GCP) Audit Strategy program within Global Development Quality Assurance, ensuring alignment with regulatory expectations and company objectives.
• • Develop and implement risk-based audit planning for assigned molecules, clinical studies, vendors, and processes based on indicators from study teams and Global Development.
• • Maintain strategic audit programs and ensure all audits are conducted in accordance with approved schedules and protocols.
• • Collect, maintain, and provide core study-specific information to support auditor preparation and execution of GCP audits.
• • Analyze audit outcomes to identify quality trends and communicate compliance risks to relevant organizational stakeholders.
• • Represent the Quality Assurance function on complex compliance projects and initiatives across functional areas and departments.
• • Schedule, prepare, conduct, report, and follow up on GCP audits as needed to support the GCP Audit group.
• • Interpret FDA, EU, and ICH regulations and guidance documents to evaluate critical compliance issues not explicitly covered by existing policies.
• • Participate in regulatory inspections as part of the control and/or inspection room team when required.
• • Draft and issue periodic management reports on audit activities, findings, and compliance metrics as requested.
• • Provide education and training to Global Development departments on GCP standards, audit processes, and regulatory expectations.
• • Ensure audit activities support the overall quality and integrity of clinical development programs across Regeneron’s pipeline.
• • Collaborate with internal teams to align audit strategies with clinical study timelines, vendor performance, and regulatory submission needs.
• • Apply risk assessment methodologies to prioritize audit focus areas and allocate resources effectively across global clinical operations.
• • Maintain up-to-date knowledge of evolving regulatory requirements and industry best practices in GCP and clinical trial oversight.
• • Support continuous improvement of audit processes through feedback loops, lessons learned, and process optimization initiatives.
• • May travel up to 10–20% domestically and internationally to support audit activities, inspections, or cross-functional initiatives.
• • Ensure all audit documentation meets regulatory standards and is maintained in compliance with company and FDA requirements.
• • Serve as a subject matter expert on GCP audit strategy within the organization, advising leadership on quality risks and mitigation approaches.
• • Coordinate with external auditors and contract research organizations (CROs) to ensure consistent application of GCP standards across sponsored studies.
• • Contribute to the development and refinement of quality assurance policies, procedures, and training materials related to clinical audit practices.