REMS Audit Oversight Lead

Responsibilities

This role will provide you the opportunity to lead key activities to progress your career. These responsibilities include some of the following:

• Develop and manage a risk-based REMS audit compliance program for products and third-party partners.
• Plan and oversee execution of compliance, audits by a third party to assess compliance with REMS requirements, regulations, and internal standards.
• Central point to trend audit findings and work with stakeholders to define and track corrective and preventative actions (CAPA).
• Serve as the subject matter expert during regulatory inspections and support inspection readiness activities.
• Create metrics and trend reports to identify systemic risks and recommend process improvements.
• Coach and mentor colleagues on audit methodology, REMS compliance, and quality expectations.

Collaboration and impact

You will work closely with regulatory affairs, medical affairs, safety, commercial, legal, and external partners. You will translate regulatory expectations into practical audit plans. You will influence change by presenting clear, evidence-based recommendations. You will help shape practices that protect patients and support timely access to medicines.