Manager, Product Complaint

Responsibilities Ensure product complaints are received, reviewed, evaluated, and investigated to determine reportability to FDA and international regulatory authorities. Manage complaint intake, triage, investigation, and closure; document activities accurately in the electronic Quality Events system. Communicate with complainants (patients, healthcare providers, distributors) to obtain complete information for investigations. Maintain complaint handling processes to comply with internal quality system requirements and applicable global regulations/standards. Monitor compliance with company policies and procedures and with FDA, EU GMP, ICH, and other applicable regulatory requirements. Develop, revise, and continuously improve SOPs and work instructions for complaint handling and vigilance activities. Initiate, document, and implement CAPAs when complaint trends, investigations, or risk assessments warrant action. Coordinate/escalate product complaints with cross-functional teams (Quality, Manufacturing, Regulatory Affairs, Medical Safety, Technical). Serve as point of contact for internal/external stakeholders; respond to requests and support cross-functional alignment. Support auditors/inspectors with documentation and subject matter expertise related to complaint handling. Deliver and update product complaint training for employees and vendors. Reconcile product complaints and adverse event/safety information monthly with Global Medical Safety/Drug Safety for regulatory reporting. Maintain complaint metrics and provide periodic status reports and trend summaries to Senior Management. Qualifications BS degree in a scientific field (e.g., Biology, Chemistry) and 5+ years’ experience in a GMP biopharmaceutical setting. Familiarity with GMP regulations (21 CFR 210/211), ICH guidelines, and FDA guidance. Familiarity with drug product aseptic manufacturing, labeling/packaging, and distribution processes. Experience leading and authoring product complaint investigations; strong written communication. Strong written and verbal communication; continuous improvement mindset. Proficient with Excel, Word, PowerPoint. Experience with electronic document management systems (e.g., Veeva) is a plus. Independent, detail-oriented, able to prioritize in a fast-paced environment. Location / Work Requirement Lexington, MA office; onsite five days per week. Pay Range $97,000 - $107,000 USD. #J-18808-Ljbffr