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,. We value clear decision-making, practical problem solving, and a commitment to learning and improvement. This role offers, 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 tasks within the complaint record. 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.
Why You?
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
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
- 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
If you have the following characteristics, it would be a plus:
- 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.
Ready to apply?
If you are motivated to help protect patients and improve quality, please apply. Tell us how your experience with complaint handling and quality systems will help our team succeed. We look forward to hearing from you.
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Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
