Quality Lead (Product Complaints)

Responsibilities

• Ensure that product complaints are properly received, routed, logged, investigated, responded to, and maintained in compliance with cGMP, FDA, regulatory, and GSK requirements.
• Coincides 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.
• Interacts 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.
• Maintains due dates to assure complete, proper, and timely investigation of product complaints.
• Contributes to the development of monthly, semi-annual, and annual reports for product complaint trending, as needed.
• Generates complaint data for Periodic Product Reviews, as needed.
• Participates in teams to present product complaints during Internal and External Regulatory inspections and prepares responses to deficiency reports, as needed.
• Participates in and supports management monitoring, independent business monitoring, corporate audits, and regulatory inspections.
• Performs Author and/or Owner responsibilities for Site Compliance documents.

Qualifications

• 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.