REMS Audit Oversight Lead

GSK•Wayne, NJ

1d•Hybrid

About The Position

This role leads oversight of Risk Evaluation and Mitigation Strategy (REMS) audit activities across the United States. The position involves designing and managing REMS compliance audit programs, partnering with cross-functional teams, and ensuring compliance with regulatory requirements. The role offers growth through high-impact work that helps protect patients and supports GSK’s mission of uniting science, technology and talent to get ahead of disease together.

Requirements

Must reside within territory for consideration with access to a major airport.
Bachelor’s degree in life sciences, healthcare, quality, or related field.
Minimum of 5 years’ experience in quality assurance, regulatory compliance, or audit within the pharmaceutical or healthcare industry.
Direct experience with REMS programs, including Experience planning and overseeing REMS audits and managing CAPA follow-up.
Experience with U.S. regulatory requirements for risk management and pharmacovigilance.

Nice To Haves

Advanced degree in life sciences, pharmacy, public health, or related field.
Strong written and verbal communication skills with experience presenting audit findings to stakeholders.
Knowledge of pharmacovigilance systems and safety reporting requirements.
Experience working with cross-functional global teams and third-party vendors and regulatory bodies.
Experience with vendor oversight.
Proficiency with data analytics, or quality metrics.
Experience operating in environments requiring rapid operational escalation and high-volume audit activities.

Responsibilities

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.
Serve as the 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.