Post-Marketing Quality Compliance Manager

Role Summary

The Post-Marketing Product Quality Compliance Manager will oversee post-market product quality activities in compliance with FDA regulations and internal Quality System requirements. This role leads and develops a team responsible for product quality complaints, post-distribution quality monitoring, and the execution of quality-driven field actions, including recalls and market withdrawals. The manager provides strategic direction, coaching, and performance management to ensure timely, compliant, and effective execution of post-market quality processes while fostering a culture of quality and continuous improvement.

Responsibilities

• Post-Market Surveillance & Data Analysis
• Manage the end-to-end product quality complaint process from intake through closure
• Assess complaints for product quality impact, GMP compliance risk, and field action triggers
• Trend and analyze post-market quality data to identify recurring or systemic issues
• Integrate post-market data into Product Lifecycle Management (PLM), APQR/PQRs, Management Review, and Quality Metrics/KPIs

• Complaint Handling & Investigations
• Provide Quality oversight of vendors supporting complaint intake or triage
• Ensure accurate, complete, and timely complaint documentation
• Perform initial Quality assessments and ensure appropriate complaint classification
• Escalate potential adverse events to Pharmacovigilance per established procedures
• Lead or oversee risk-based investigations that identify root cause, assess scope and recurrence, and are supported by objective evidence and manufacturing history

• Quality Risk Management & Field Actions
• Escalate critical or high-risk quality issues in a timely manner
• Identify and assess potential recalls, market withdrawals, or corrections
• Lead quality-driven recalls, including regulatory notifications, documentation, and effectiveness checks
• Maintain recall readiness through procedures, training, and periodic exercises

• CAPA, Quality Systems & Compliance
• Drive CAPAs resulting from post-market quality issues and verify effectiveness
• Maintain and improve SOPs related to complaints, post-market monitoring, recalls, and vendor oversight
• Ensure compliance with FDA regulations and internal Quality System requirements

• Audit & Inspection Support
• Oversee Internal Audit program and Inspection Readiness
• Act as a Quality SME during FDA inspections and audits
• Support preparation of inspection responses and supporting documentation related to post-market quality activities

Qualifications

• Education: Bachelor’s degree in Life Sciences, Engineering, or a related field (Master’s preferred)
• Professional Experience: Minimum 7 years of experience in Quality within a regulated pharmaceutical, biologics, or cell therapy environment
• Leadership: 2 years of people management experience
• SME Knowledge: Hands-on experience with product complaints, post-market quality surveillance, and recalls or field actions
• External Oversight: Experience overseeing external vendors in a regulated Quality environment
• Regulatory Foundation: Strong knowledge of FDA Quality System and post-market requirements
• Technical Skills: Proven investigation, CAPA, and inspection-readiness experience