Lead, Complaints Investigation & Quality Analytics

Kindeva; California; On-site; USD 90,000 - 130,000; Full time

Job summary

Kindeva is seeking a Complaint Specialist to provide technical leadership in the complaints department, overseeing investigations, trend analysis, and regulatory reporting such as FAR assessments. This on-site role focuses on ensuring compliant, timely handling of customer concerns and driving improvements.

Ideal candidates will have 4+ years in pharmaceutical quality or complaint handling, strong data analysis and writing skills, and proficiency in Excel and Minitab to support ongoing QA

Qualifications

• Regulatory knowledge
• Data analysis
• Technical writing
• Process improvement

Responsibilities

• Serve as the subject matter expert for QMS complaint module.
• Assist with metric tracking including Tier meetings, monthly and quarterly reviews.
• Review complaints to determine regulatory reporting requirements and issue FAR assessments.
• Review and assist in complaint investigations with corrective feedback.
• Lead complaint trend analysis and communicate findings to upper management.
• Provide complaint data and memos for PQRs and other requests.
• Contribute to Post-Market Surveillance, FARs, and Adverse Event Reporting.
• Lead continuous improvement projects relevant to the department.
• Ensure complaint handling complies with regulatory requirements (FDA/ISO) and internal procedures.
• Ensure timely and professional handling of customer concerns.

Job description

Kindeva is seeking a Complaint Specialist to provide technical leadership in the complaints department, overseeing investigations, trend analysis, and regulatory reporting such as FAR assessments. This on-site role focuses on ensuring compliant, timely handling of customer concerns and driving improvements.

Ideal candidates will have 4+ years in pharmaceutical quality or complaint handling, strong data analysis and writing skills, and proficiency in Excel and Minitab to support ongoing QA