Quality Lead (Product Complaints)

Position Summary You will lead the day-to-day quality management of product complaints for a U.S. site. You will manage investigations, drive corrective actions, and ensure complaint handling meets regulatory and company requirements. You will work closely with colleagues in Quality, Manufacturing, Supply, Regulatory, and Medical Affairs. We value clear decision-making, practical problem solving, and a commitment to learning and improvement. This role offers growth, meaningful impact for patients, and work that aligns with our mission of uniting science, technology and talent to get ahead of disease together. Responsibilities This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Ensure that product complaints are properly received, routed, logged, investigated, responded to, and maintained in compliance with cGMP, FDA, regulatory, and GSK requirements. Coordinates investigations associated with product complaints. Participates in investigations to provide the quality views on the root cause and CAPA determinations as needed. Performs the final approval on the product complaint investigations. Interact with LOC personnel as needed to contact medical professionals, pharmacists, customers, vendors, and GSK personnel to request answers for technical questions in order to process complaints. Monitor due dates to assure complete, proper, and timely investigation of product complaints. Contribute to the development of monthly, semi-annual, and annual reports for product complaint trending, as needed. Generate complaint data for Periodic Product Reviews, as needed. Participate in teams to present product complaints during Internal and External Regulatory inspections and prepare responses to deficiency reports, as needed. Participates in and supports management monitoring, independent business monitoring, corporate audits, and regulatory inspections. Perform Author and/or Owner responsibilities for Site Compliance documents. Working model This role is hybrid. You will be on site regularly and also have flexibility to work remotely when appropriate. Expect occasional travel for audits, supplier or regulatory interactions. Basic Qualification Bachelor’s degree in a scientific, engineering, or related discipline, or equivalent experience. 3+ years of quality experience in a pharmaceutical, biologics, or related regulated manufacturing environment. Direct experience managing product complaints, investigations, CAPA, or similar quality processes. Experience with complaint tracking systems, quality documentation, and basic data trending. Preferred Qualification Experience approving complaint investigations and acting as final quality reviewer. Familiarity with complaint‑related reporting for periodic product review and regulatory submissions. Experience supporting regulatory inspections and preparing responses to inspection observations. Knowledge of risk management, CAPA systems, and root cause analysis tools. Experience working with cross‑functional teams including Medical, Regulatory, and Supply. Demonstrated ability to drive process improvements and simplify quality workflows. Solid understanding of Good Manufacturing Practices (GMP) and applicable regulatory expectations in the U.S. Strong written and verbal communication skills for technical interactions with internal and external stakeholders. What we value We look for people who act with transparency, respect, and integrity. You will make decisions based on evidence and apply judgment to balance speed, rigor, and risk. We value teamwork, curiosity, and a commitment to learning. We welcome applicants from all backgrounds and experiences and promote an environment of inclusion where everyone can bring their best. 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. 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 #J-18808-Ljbffr NCBiotech