Manager, Product Complaint
Kiniksa Pharmaceuticals
August 21, 2026
On-site
Lexington, MA
Operations
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 (e.g., patients, HCPs, distributors) to obtain complete information for investigations.
- Maintain and execute complaint handling processes to ensure compliance with internal quality requirements and applicable global regulations/standards.
- Monitor compliance with company policies and procedures and FDA, EU GMP, ICH, and other applicable regulatory requirements.
- Contribute to development/revision of SOPs and work instructions for complaint handling and vigilance activities.
- Initiate, document, and implement CAPAs when warranted by complaint trends, investigations, or risk assessments.
- Escalate product complaints and collaborate cross-functionally with Quality, Manufacturing, Regulatory Affairs, Medical Safety, and Technical teams.
- Serve as point of contact for internal/external stakeholders; support cross-functional alignment.
- Support auditors/inspectors with documentation, explanations, and subject matter expertise.
- Deliver and update product complaint training for relevant employees and vendors.
- Reconcile product complaints and adverse event/safety information monthly with Global Medical Safety/Drug Safety.
- Maintain complaint metrics/tracking tools; provide periodic status reports and trend summaries to Senior Management.
Qualifications:
- BS 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 documents.
- Familiarity with drug product aseptic manufacturing, labeling/packaging, and distribution.
- Experience leading/authoring product complaint investigations; strong writing and communication skills.
- Proactive continuous improvement mindset.
- Proficient with Excel, Word, PowerPoint; Veeva (or similar electronic document management system) a plus.
- Strong attention to detail; ability to prioritize in a fast-paced environment.
Pay Range:
- $131,500 - $146,500 USD
- 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 (e.g., patients, HCPs, distributors) to obtain complete information for investigations.
- Maintain and execute complaint handling processes to ensure compliance with internal quality requirements and applicable global regulations/standards.
- Monitor compliance with company policies and procedures and FDA, EU GMP, ICH, and other applicable regulatory requirements.
- Contribute to development/revision of SOPs and work instructions for complaint handling and vigilance activities.
- Initiate, document, and implement CAPAs when warranted by complaint trends, investigations, or risk assessments.
- Escalate product complaints and collaborate cross-functionally with Quality, Manufacturing, Regulatory Affairs, Medical Safety, and Technical teams.
- Serve as point of contact for internal/external stakeholders; support cross-functional alignment.
- Support auditors/inspectors with documentation, explanations, and subject matter expertise.
- Deliver and update product complaint training for relevant employees and vendors.
- Reconcile product complaints and adverse event/safety information monthly with Global Medical Safety/Drug Safety.
- Maintain complaint metrics/tracking tools; provide periodic status reports and trend summaries to Senior Management.
Qualifications:
- BS 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 documents.
- Familiarity with drug product aseptic manufacturing, labeling/packaging, and distribution.
- Experience leading/authoring product complaint investigations; strong writing and communication skills.
- Proactive continuous improvement mindset.
- Proficient with Excel, Word, PowerPoint; Veeva (or similar electronic document management system) a plus.
- Strong attention to detail; ability to prioritize in a fast-paced environment.
Pay Range:
- $131,500 - $146,500 USD