Kiniksapharmaceuticals
Manager, Product Complaint
Lexington, MA
Sponsorship not specifiedDetected 12 days ago
ExcelGMPFDA RegulatoryPharmacovigilanceCommunicationCollaborationMicrosoft OfficeRegulatory Affairs
About the role
- Grounded in rigorous science and bold innovation, the company fosters a highly collaborative, patient‑first culture led by accomplished life sciences leaders.
- At Kiniksa, talented individuals are trusted and empowered to make a real impact-shaping the future of medicine while improving the lives of patients who need it most.
- 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.
Responsibilities
- Manage and perform complaint intake, triage, investigation, and closure, documenting all activities accurately and contemporaneously within the electronic Quality Events system.
- Initiate, document, and implement Corrective and Preventive Actions (CAPAs) when complaint trends, investigations, or risk assessments warrant action, in accordance with established procedures.
- 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.
- Maintain accurate complaint metrics and tracking tools and provide periodic status reports and trend summaries to Senior Management.
- Maintain and execute complaint handling processes and procedures to ensure compliance with internal quality system requirements and applicable global regulations and standards.
- Maintains a strong commitment to patient safety by ensuring accurate evaluation, documentation, and timely reporting of complaints and adverse events.
- Understanding and familiarity with GMP regulations, including 21 CFR 210 and 211, ICH guidelines, FDA guidance documents
- Kiniksa Pharmaceuticals is a commercial‑stage biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications.
- With deep expertise in immunology and inflammation, Kiniksa is advancing a growing portfolio of approved and investigational medicines, anchored by its lead product, ARCALYST®, the first and only FDA‑approved therapy for recurrent pericarditis.
Requirements
- Requires a Bachelor of Science degree in scientific field (e.g., Biology, Chemistry) with 5+ years' experience in a GMP biopharmaceutical setting
- 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
- Proven mindset of proactive continuous improvement
Benefits
- Communicate directly with complainants (e.g., patients, healthcare providers, distributors) to obtain complete and accurate information necessary to support product complaint investigations.
- Coordinate and actively participate in the escalation of product complaints, including cross‑ functional collaboration with Quality, Manufacturing, Regulatory Affairs, Medical Safety, and Technical teams.
- Perform monthly reconciliation of product complaints and adverse event/safety information with Global Medical Safety / Drug Safety to ensure accurate and complete regulatory reporting.
- Partners with Quality, Manufacturing, Regulatory, and Medical Safety teams to escalate, resolve, and continuously improve complaint management processes.
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This listing is sourced directly from Kiniksapharmaceuticals's careers page and normalized into a canonical job model.