Post-Marketing Quality Compliance Manager

Capricor Therapeutics(27 days ago)

San Diego, CAOnsiteFull TimeManager$134,628 - $176,627 (estimated)Quality Assurance

About this role

The Post-Marketing Product Quality Compliance Manager at Capricor Therapeutics oversees all post-market product quality activities to ensure compliance with FDA regulations and internal quality systems. The role manages a team responsible for complaints, post-distribution monitoring, and quality-related field actions such as recalls and withdrawals. The manager provides strategic direction and performance management while embedding post-market data into broader quality and product lifecycle processes. This position also serves as a quality subject matter expert during audits and inspections, supporting a strong culture of quality and continuous improvement.

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Required Skills

Post-Market Surveillance
Data Analysis
Complaint Management
GMP Compliance
Risk Assessment
Root Cause Analysis
Quality Risk Management
Field Actions
Recall Management
CAPA Management

+8 more

Qualifications

Bachelor’s Degree in Life Sciences
Bachelor’s Degree in Engineering
Master’s Degree in Life Sciences
Master’s Degree in Engineering

About Capricor Therapeutics

capricor.com

Capricor Therapeutics, Inc. (NASDAQ: CAPR) is a San Diego–based biotechnology company developing cell- and exosome-based therapeutics for muscular and other select diseases. Its lead candidate, deramiocel (CAP‑1002), is an allogeneic cell therapy currently in Phase 3 clinical development for Duchenne muscular dystrophy. Capricor is also advancing exosome technology as a next‑generation platform, engineering exosomes to deliver nucleic acids and proteins to treat or prevent a variety of diseases. The company focuses on translating these platforms into novel therapeutic and preventive products.