Product Lifecycle Compliance Team Leader

GSK•Zebulon, NC

1d•Hybrid

About The Position

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.

Requirements

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.

Nice To Haves

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.

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.