REMS Audit Oversight Lead

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade.

Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting‑edge technology to transform people’s lives.

GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success.

This is a U. S.-based remote role aligned to East Coast working hours. Some travel may be required.

At GSK, 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.

You will also coach and mentor colleagues on audit methodology and REMS compliance, ensuring continuous improvement.

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 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 and influence change by presenting clear, evidence‑based recommendations.

You will help shape practices that protect patients and support timely access to medicines.

Qualifications

• Basic Qualification
• We are seeking professionals with the following required skills and qualifications:
• 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 planning and overseeing REMS audits and managing CAPA follow‑up.
• Experience with U. S. regulatory requirements for risk management and pharmacovigilance.
• Preferred Qualification
• 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.
• Working model and 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 & benefits

The U.

S. annual base salary for new hires in this position ranges from $126,750 to $211,250.

This role also offers an annual bonus and eligibility to participate in a share‑based long‑term incentive program, as well as health care and other insurance benefits for employee and family, retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.

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.

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