Post-Marketing Quality Compliance Manager

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.

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.

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.

Why Capricor?Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that’s transforming lives with every breakthrough.
Come Work With Us!At Capricor, you’ll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies.
Please note that Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contac