Position Summary
You will lead a team responsible for the site Product Lifecycle Compliance function, including the Regulatory Compliance and Stability Operations & Retains Management teams, as well as ownership of the Periodic Product Review (PPR) program. You will partner across the site and externally with GSK Regulatory Affairs, LOCs, other GSK sites, and relevant business functions to implement regulatory and stability requirements and support compliant product supply. We value clear decision making, practical problem solving, and coaching. This role offers strong growth, visible impact on patient safety, and the chance to help unite 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:

• Coach, develop and lead the Regulatory Compliance and Stability Operations & Retains Management teams.
• Providing leadership to ensure regulatory commitments, submissions, license renewals, registrations, quality agreements, change controls, product reviews, stability studies, stability reporting, sample management, and retain storage activities remain compliant with global health authority and GSK requirements
• Maintaining inspection readiness across the teams while driving capability development, effective decision-making, and continuous improvement.
• Provide site support for health authority and internal inspections and maintain ongoing inspection readiness across Regulatory Compliance and Stability Operations & Retains Management activities.

Responsibilities

• Own and manage the site Periodic Product Review (PPR) program and schedule, ensuring monthly product review activities are completed accurately, compliantly, and within established timelines.
• Oversee regulatory assessment of proposed technical changes through the Change Control System, providing guidance on submission impact, Regulatory Implementation Strategy (RIS), registered commitments, and change scope.
• Partner with GSK Regulatory Affairs, LOCs, Quality, other GSK sites, and relevant business functions to maintain licenses, registrations, regulatory commitments, submissions, and market requirements in compliance with applicable health authority and GSK requirements.
• Oversee Quality Agreements, IQAs, and QAPRSs associated with US-marketed products managed by Zebulon, products supplied by Zebulon, and CMO-managed products.
• Oversee the receipt, storage, setup, delivery, and control of stability samples in accordance with approved registered protocols, methods, specifications, market requirements, GMP expectations, and established timelines.
• Ensure annual stability commitments, stability data reporting, sample storage, and retain storage requirements are accurately defined, maintained, monitored, and reported to applicable regulatory authorities, local site QA, and other GSK sites as required.

Work arrangement
This role is hybrid. You will be expected to work on-site regularly, with flexibility for remote work as agreed with your manager.

Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals

• 8+ years experience in a GMP-regulated pharmaceutical environment, with 5+ years of relevant experience in a quality or compliance role.

• Experience leading people and cross-functional activities.
• Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biology, Engineering, or other relevant scientific or technical discipline or sufficient technical depth or professional experience.
• Demonstrated experience with US regulatory requirements, experience supporting regulatory inspections, and strong experience with good manufacturing practices.
• Knowledge of product lifecycle compliance activities, including regulatory commitments, submissions, registrations, license renewals, change controls, product reviews, stability programs, and associated reporting requirements.

Preferred Qualification
If you have the following characteristics, it would be a plus

• Advanced degree in a scientific, technical, or regulatory discipline.
• Experience managing quality agreements and supplier or third-party oversight.
• Experience with periodic product review programs and product lifecycle compliance activities.
• Good working knowledge of GSK marketed products (US & International) with emphasis on Chemistry, Manufacturing and Controls (CMC).
• Strong written and verbal communication skills and comfort preparing leadership reports and dashboards.
• Experience in continuous improvement or operational excellence programs.

How to apply
If this role fits your experience and ambitions, please apply. Tell us briefly how your background meets the basic qualifications. Include one short example of a compliance challenge you led and the outcome. We look forward to learning how you can help us get ahead of disease together.

About the Zebulon Site

GSK's Zebulon site is a global supplier of Respiratory and Solid Dose medicines to patients around the globe and the largest GSK Pharmaceutical secondary manufacturing site in North America. The site is located less than 30 minutes from downtown Raleigh, Wendell, Knightdale, Rocky Mount, Wilson, and Wake Forest.

Key differentiators about GSK and Zebulon:

• Our commitment to inclusion is seen as a critical advantage of ours
• Our focus on cultivating a positive work environment that cares for our employees
• Demonstrated opportunities for continued career growth driven by individual ambition
• Leaders that care about their teams and growth of both individuals and the company
• A priority focus on Safety and Quality
• Clean and GMP compliant work environment
• Onsite cafeteria
• Onsite gym
• Temperature-controlled climate
• Licensed, onsite Health & Wellness clinic

#LI-GSK

Skills
Data Integrity, Digital Fluency, GxP Regulations, Influencing Without Authority, Lean Management, Pharmaceutical Regulatory Compliance, Problem Solving, Quality Assurance (QA), Risk Awareness, Technical Writing

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.