Manager of Quality Assurance Product Complaints

Job Responsibilities:

• Serve as QA owner for clinical-stage combination product complaints.
• Ensure timely assessment of complaints for potential impact to patient safety.
• Review and approve complaint records, investigation reports, and final dispositions.

Regulatory & Inspection Support:

• Maintain current knowledge of global complaint handling and quality regulations.
• Partner with Regulatory Affairs and Pharmacovigilance to support complaint-related regulatory submissions.
• Prepare and review responses to regulatory questions, findings, and commitments related to product complaints.

Qualifications:

• Hands-on experience with product complaints and investigations required
• Proven experience managing complaint investigations, root cause analysis, CAPA development, and trending.
• Strong interpersonal and communication skills with the ability to influence cross-functional and external partners.