The posting
Business Introduction We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply. We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.
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.
Why You?
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.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
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 get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. 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.
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 - [email protected]
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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