REMS Audit Oversight Lead

Role Overview You will lead oversight of Risk Evaluation and Mitigation Strategy (REMS) audit activities across the United States, designing and managing REMS compliance audit programs, partnering with cross‑functional teams, and ensuring compliance with regulatory requirements. 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. Central point to trend audit findings and work with stakeholders to define and track corrective and preventive 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. Basic Qualifications Must reside within territory for consideration with access to a major airport. Bachelor’s degree in life sciences, healthcare, quality, or a 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 planning, overseeing REMS audits and managing CAPA follow‑up. Experience with U.S. regulatory requirements for risk management and pharmacovigilance. Preferred Qualifications Advanced degree in life sciences, pharmacy, public health, or a 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, 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. Working Model & Travel This is a U.S.-based remote role aligned to East Coast working hours. Some domestic travel (up to 10%) may be required for stakeholder meetings. Salary and Benefits The U.S. annual base salary for new hires in this position ranges from $126,750 to $211,250. The range reflects factors such as location, experience, education, and market rates. The role also offers an annual bonus and eligibility to participate in a share‑based long‑term incentive program. Benefits include health care and insurance for employees and families, retirement plans, paid holidays, vacation, and paid caregiver/parental and medical leave. Equal Opportunity Employer GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. #J-18808-Ljbffr GlaxoSmithKline