Post-Marketing Quality Compliance Manager

Responsibilities

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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.

Requirements

• 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.