Quality Lead (Product Complaints)

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 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.

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.