Post-Marketing Quality Compliance Manager

Capricor Therapeutics • San Diego, CA

8d

About The Position

Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel ( CAP-1002 ), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most. 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.

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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 101-250 employees