Manager, Product Complaint

Responsibilities

• Ensure all product complaints are received, reviewed, evaluated, and investigated in accordance with applicable procedures to determine reportability to FDA and international regulatory authorities.
• Manage and perform complaint intake, triage, investigation, and closure, documenting all activities accurately and contemporaneously within the electronic Quality Events system.
• Communicate directly with complainants (e.g., patients, healthcare providers, distributors) to obtain complete and accurate information necessary to support product complaint investigations.
• Maintain and execute complaint handling processes and procedures to ensure compliance with internal quality system requirements and applicable global regulations and standards.
• Monitor and ensure ongoing compliance with company policies and procedures, as well as FDA, EU GMP, ICH, and other applicable regulatory requirements.
• Contribute to the development, revision, and continuous improvement of SOPs and work instructions related to complaint handling and vigilance activities.
• Initiate, document, and implement Corrective and Preventive Actions (CAPAs) when complaint trends, investigations, or risk assessments warrant action, in accordance with established procedures.
• Cook up and actively participate in the escalation of product complaints, including cross-functional collaboration with Quality, Manufacturing, Regulatory Affairs, Medical Safety, and Technical teams.
• Serve as a point of contact for internal and external stakeholders, responding to requests, explaining complaint handling processes, and supporting cross-functional alignment.
• Interact with internal, domestic, and international auditors and inspectors, providing documentation, explanations, and subject matter expertise related to complaint handling processes.
• Coordinate and ensure appropriate training is delivered to relevant employees and vendors; develop and deliver product complaint training and periodically assess and update training materials to ensure effectiveness.
• Perform monthly reconciliation of product complaints and adverse event/safety information with Global Medical Safety / Drug Safety to ensure accurate and complete regulatory reporting.
• Engages effectively with complainants, auditors, and internal teams while delivering training to ensure consistent execution of complaint handling practices.
• Maintain accurate complaint metrics and tracking tools and provide periodic status reports and trend summaries to Senior Management.

Qualifications

• Requires a Bachelor of Science degree in scientific field (e.g., Biology, Chemistry) with 5+ years’ experience in a GMP biopharmaceutical setting.
• Understanding and familiarity with GMP regulations, including 21 CFR 210 and 211, ICH guidelines, FDA guidance documents.
• Understanding and familiarity with processes for drug product aseptic manufacturing, labeling/packaging, and distribution.
• A proactive, detailed oriented person, with experience in leading and authoring product complaint investigations, and the ability to clearly and accurately present information in writing.
• Demonstrated strong written and verbal communication skills.
• Proven mindset of proactive continuous improvement.
• Proficient with Excel, Word, PowerPoint.
• Experience with electronic document management system, such as Veeva, a plus.
• Efficient independent worker with ability to focus and drive for results.
• Strong attention to detail.
• Able to prioritize numerous activities in a rapid paced environment.

Pay

Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks. Pay Range $97,000 - $107,000 USD.