C
Capricor3mo ago
USD 113487–136324/yr

Post-Marketing Quality Compliance Manager

United StatesSan DiegoFull-time (exempt)mid
OtherPostPost Marketing Quality Compliance Manager
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Quick Summary

Overview

Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases.

Technical Tools
OtherPostPost 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.

  • 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.
  • 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.
  • Listing Details

    Posted
    January 7, 2026
    First seen
    March 26, 2026
    Last seen
    April 21, 2026

    Posting Health

    Days active
    25
    Repost count
    0
    Trust Level
    42%
    Scored at
    April 21, 2026

    Signal breakdown

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    Post-Marketing Quality Compliance ManagerUSD 113487–136324