Manager, Product Complaint
Kiniksa Pharmaceuticals
12 days ago
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 (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.
- 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.