Product Release Leader

Site Name: USA - North Carolina - ZebulonPosted Date: May 22 2026Business IntroductionWe 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 SummaryYou will release product that is manufactured and/or packaged in compliance with regulatory agencies’ requirements and company standards. Provide quality oversight to Zebulon Production, Technical and Logistics departments to ensure their activities are in compliance with regulatory agencies’ requirements and company standards.ResponsibilitiesThis role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:Provides support to the batch document review, release, and second check process to ensure that products released to market have been manufactured and packaged in accordance with cGMP and meets company specifications/requirements prior to release. May perform batch document review activity when required and actively performs release activities.Coordinates investigations associated with production deviations. Participates in investigations to provide the quality views on the root cause and CAPA determinations. Closes Planned (PR) Notifications associated with site and production activities.Provides quality support to production through Rapid Response and Root Cause Analysis investigations for Quality Incidents in operations, involving operators, to ensure full understanding of the incident at the time it occurred. Partners with the compliance, validation and technical teams, as needed, to agree remedial actions during/after production issues.Agrees personal objectives from the quality strategy, develops oneself, acts as a coach and mentor when required to support the development of others, and assists with New Employee training.Communicates effectively with team members and production ensuring quality issues are addressed and, if required, escalated in a timely manner to team lead.Participates in and supports self-inspections, internal audits and regulatory inspections acting as quality SME for quality processes, batch documents and deviations.Approves GMP related documentation such as master batch documents, SOPs/Forms and approves any changes associated with these documents.Supports/Leads the delivery of business benefits through the continuous improvement framework and works with the team lead to establish lead and lag measure to track improvements.Supports certificate (CofA, CofC) creation, review and second check verification in alignment with market requirements and GSK standards.Attends flow/tier meetings to ensure product release activities are aligned to the business needs and delays are clearly communicated for assessment of impact as well as provides on-call support, as needed for the business.Why You?Work arrangementThis role will require 100% on-site for hands-on release activities and inspections. Some Nights and Weekends will be expected wit this role.Basic QualificationWe are seeking professionals with the following required skills and qualifications to help us achieve our goals:High school diploma plus 8 years' experience in the pharmaceutical industry or associate's degree plus 6 years' experience in the pharmaceutical industry or BS/BA degree with 4 years' experience in the pharmaceutical industry in Quality.2+ years of experience in lot release, batch record review, or quality operations in a regulated life sciences environment.Experience working with quality systems such as deviations, CAPA, change control, and document control.Preferred QualificationIf you have the following characteristics, it would be a plus:Bachelor’s degree in a scientific, engineering, or quality discipline.Proven ability to communicate and influence at most levels of management.Strong understanding and application of DI principles.Ability to function in an atmosphere of constant change with detailed accuracy.Excellent understanding of Microsoft Office suite products and MERP for batch release, due date monitoring, and information gathering.Knowledge and application of the principles of Quality Management Systems (QMS).Knowledge of cGMP - FDA and other Regulatory requirements.Knowledge of Pharmaceutical Processes.Demonstrated knowledge of continuous improvement methodologies.Demonstrated collaboration, negotiation & conflict resolution skills.Ability to multi-task & handle tasks with competing priorities effectively.Technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures).About The Zebulon SiteGSK’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 What we valueWe look for people who act with integrity, put patients first, and work well with others. We welcome applicants from different backgrounds and encourage people who bring varied perspectives to apply. If you are ready to grow your career, deepen your release expertise, and make a real impact on patients, please apply and tell us how your experience fits this role.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 - usrecruitment.adjustments@gsk.comGSK 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.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. 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. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/