GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases. Our culture of being ambitious for patients, accountable for impact, and doing the right thing is the foundation for how we deliver for patients, shareholders, and our people.
REMS Audit Oversight Lead
Location
United States
Posted
4 days ago
Salary
$126.8K - $211.3K / year
Seniority
Lead
No structured requirement data.
Job Description
REMS Audit Oversight Lead
GSK
Role Description This is a U.S.-based remote role aligned to East Coast working hours. Some travel may be required. You will lead oversight of Risk Evaluation and Mitigation Strategy (REMS) audit activities across the United States. You will design and manage REMS compliance audit programs, partner with cross-functional teams, and ensure compliance with regulatory requirements. We value clear thinking, collaboration, and a focus on continuous improvement. This 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. 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. 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. Qualifications - 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. Requirements - 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. Benefits - The US annual base salary for new hires in this position ranges from $126,750 to $211,250. - This position offers an annual bonus and eligibility to participate in our share-based long-term incentive program. - Available benefits include health care and other insurance benefits (for employee and family). - Retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.
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