Product Quality Complaints Manager

Job Overview

This position reports to the Senior Director, PV Quality Assurance and is part of the Quality department which is responsible for ensuring compliant management of product complaints associated with commercial and clinical products. The role is responsible for the intake, assessment, investigation, documentation, and closure of product complaints in accordance with applicable regulatory requirements and company procedures and works closely with Pharmacovigilance, Manufacturing, Quality Assurance, and external partners to support product quality, patient safety, and regulatory compliance.

Essential Functions

• Manage the intake, assessment, documentation, investigation, and closure of product complaints for commercial and clinical products in accordance with applicable regulations and company procedures
• Receive, evaluate, and process product complaints, including identification and forwarding of potential adverse event, lack-of-effect, and product quality reports to appropriate functions
• Conduct and coordinate complaint investigations with internal and external stakeholders to obtain information necessary to support complaint evaluations and product quality assessments
• Ensure complaint records are complete, accurate, well-written, fact-based, and maintained in a state of inspection readiness
• Manage follow-up activities with consumers, healthcare professionals, pharmacies, distributors, and other external contacts as necessary to obtain complaint information and supporting documentation
• Coordinate product sample return activities, sample tracking, laboratory testing requests, and related complaint documentation
• Draft and issue complaint response communications as required
• Maintain compliance with cGMP requirements, regulatory expectations, and internal quality procedures
• Review and approve product complaint records, investigations, assessments, customer communications, and closure documentation to ensure completeness, accuracy, compliance, and adherence to company procedures
• Exercise independent judgment in evaluating complaint information, determining investigation requirements, assessing product quality impact, and recommending appropriate disposition and closure activities

Knowledge, Skills and Abilities

• Strong knowledge of FDA, global GMP, pharmacovigilance, and product complaint regulations and guidance
• Demonstrated experience managing pharmaceutical, biotechnology, medical device, and/or combination-product complaint processes
• Excellent investigation, root cause analysis, problem-solving, and risk assessment skills
• Experience utilizing electronic quality management systems (eQMS) and complaint management databases
• Strong written and verbal communication skills, with the ability to communicate effectively across all levels of the organization
• Ability to effectively prioritize multiple competing activities in a fast-paced, highly regulated environment
• Strong attention to detail and commitment to data integrity and documentation quality

Education & Experience Requirements

• Bachelor’s degree in a related field required
• Solid experience with product complaints, investigations, quality systems, and regulatory compliance activities required
• Working knowledge of cGMP requirements and quality management systems required
• Minimum 4 years of relevant experience in biotech or pharmaceutical industry, Bachelor’s Degree or equivalent years of work experience
• Minimum 3 years of product complaint experience required

Other Requirements

• Comprehensive understanding of cGMP requirements and pharmaceutical quality systems
• Ability to maintain confidentiality and handle sensitive product quality and patient information
• Ability to work independently and make sound, risk-based decisions using independent judgment

Travel Requirements

Primarily remote role with periodic on-site meetings in office. Must be able to travel domestically and internationally as needed.

Mental/Physical Requirements

Fast-paced environment handling multiple demands is involved. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

People Management

This is an individual contributor role and does not have direct reports or formal people-management responsibilities.