Quality Assurance Complaints Manager

ITF Therapeutics LLC; Concord (MA); On-site; USD 140,000 - 160,000; Full time

Job summary

ITF Therapeutics LLC in Concord, MA is seeking an experienced PQC professional to own the product quality complaints process and related training. You will coordinate with pharmacovigilance, NDA/BLA holders, and Quality leadership to maintain compliant PQC programs.

You will lead investigations with manufacturing sites, manage vendor relationships, and drive continuous improvement, ensuring patient safety and regulatory readiness across US operations.

Qualifications

• 5+ years of progressive experience in Quality or Product Quality Complaints in biotech/pharma.
• Strong foundation with FDA and international regulatory experience.

Responsibilities

• Day-to-day oversight of PQC activities including intake, triage, file closure, and inbox management.
• Coordinate investigations with manufacturing sites and ensure proper documentation in complaint files.
• Notify pharmacovigilance, NDA/BLA holders, and Quality leadership in a timely manner.
• Lead PQC awareness training for internal staff and vendors/partners using the LMS.
• Manage vendor relationships and contract language related to PQC.

Skills

Quality complaints management

FDA regulations

Education

Bachelor’s degree in STEM

Job description

ITF Therapeutics LLC in Concord, MA is seeking an experienced PQC professional to own the product quality complaints process and related training. You will coordinate with pharmacovigilance, NDA/BLA holders, and Quality leadership to maintain compliant PQC programs.

You will lead investigations with manufacturing sites, manage vendor relationships, and drive continuous improvement, ensuring patient safety and regulatory readiness across US operations.