Gsk
REMS Audit Oversight Lead
Home Worker - USA
Sponsorship not specified$127k-$211kDetected 15 days ago
Data AnalysisComplianceProcurementHRPublic HealthFDA RegulatoryPharmacovigilanceCommunicationCollaborationPublic SpeakingRegulatory Affairs
About the role
- 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.
- We're uniting science, technology, and talent to get ahead of disease together.
- This is a U.S.-based remote role aligned to East Coast working hours.
Responsibilities
- Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
Requirements
- Some travel may be required.
- All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK.
Nice to have
- Experience working with cross-functional global teams and third-party vendors and regulatory bodies.
- Proficiency with data analytics, or quality metrics.
- Experience operating in environments requiring rapid operational escalation and high-volume audit activities.
- Some domestic travel (up to 10%) may be required for stakeholder meetings.
- 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).
- Coach and mentor colleagues on audit methodology, REMS compliance, and quality expectations.
- Direct experience with REMS programs, including Experience planning and overseeing REMS audits and managing CAPA follow-up.
Compensation
- The US annual base salary for new hires in this position ranges from $126,750 to $211,250.
Benefits
- 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.
- respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.
Equal opportunity
- If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - usrecruitment.adjustments@gsk.com
- GSK is an Equal Opportunity Employer.
This listing is sourced directly from Gsk's careers page and normalized into a canonical job model.