Quality Lead; Product Complaints

Position Summary

You will lead the day-to-day quality management of product complaints for a multi-market site based in the US. You will manage the complaint samples and records, follow-up with investigators on progress, communicate across GSK, and ensure complaint handling meets regulatory and company requirements. You will work closely with colleagues in Quality, Manufacturing, and Supply. This role offers meaningful impact for patients and aligns with our mission of uniting science, technology, and talent to get ahead of disease together.

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.

• Ensure that product complaints are properly received, routed, logged, investigated, responded to, and maintained in compliance with cGMP, FDA, regulatory, and GSK requirements.
• Coordinate tasks within the complaint record.
• Participate in investigations to provide the quality views on the root cause and CAPA determinations as needed.
• Perform 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.
• Participate in and support management monitoring, independent business monitoring, corporate audits, and regulatory inspections.
• Perform Author and/or Owner responsibilities for Site Compliance documents.

• 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.

• 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.

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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