Reporting to the Senior Director, Quality Assurance, GMP, the Product Complaint Manager will support the management of product complaints to ensure compliance with global regulations associated with marketed and investigational products. This role is accountable for ensuring the product complaint handling process remains compliant, inspection-ready, and aligned with patient safety and regulatory expectations at all times.
This role is based in our Lexington, MA office and requires employees to be onsite five days per week.
Responsibilities (including, but not limited to):- 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.
- Coordinate 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.
- 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.
- Maintain accurate complaint metrics and tracking tools, and provide periodic status reports and trend summaries to Senior Management.
Standout Skills for Impact: Regulatory Compliance & Inspection Readiness
- Ensures product complaint processes remain compliant, inspection-ready, and aligned with FDA, EU GMP, ICH, and global regulatory expectations.
Complaint Investigation & Risk Assessment
- Leads end-to-end complaint handling (intake through closure), driving thorough investigations and determining regulatory reportability with precision.
- Cross-Functional Collaboration
- Partners with Quality, Manufacturing, Regulatory, and Medical Safety teams to escalate, resolve, and continuously improve complaint management processes.
Patient Safety & Quality Focus
- Maintains a strong commitment to patient safety by ensuring accurate evaluation, documentation, and timely reporting of complaints and adverse events.
Process Excellence & Continuous Improvement
- Enhances SOPs, drives CAPAs, monitors trends, and improves systems to strengthen quality outcomes and operational efficiency.
Stakeholder Communication & Training
- Engages effectively with complainants, auditors, and internal teams while delivering training to ensure consistent execution of complaint handling practices.
Qualifications and Experience: - 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
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
