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. 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.

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.com

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.

Important notice to Employment businesses/ Agencies

GSK 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/