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Capricor Therapeutics, Inc. · 1 day ago

Post-Marketing Quality Compliance Manager

San Diego, CA

Full-time

Onsite

Senior Level

$113K/yr - $136K/yr

7+ years exp

Capricor Therapeutics is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. The Post-Marketing Product Quality Compliance Manager will oversee post-market product quality activities in compliance with FDA regulations and internal Quality System requirements, leading a team responsible for product quality complaints and ensuring effective execution of quality-driven field actions.

BiotechnologyHealth CareMedicalTherapeutics

Responsibilities

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

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

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

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

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

Qualification

FDA Quality SystemPost-market quality surveillanceCAPA experienceComplaint handlingRegulatory knowledgeInvestigation skillsLeadership experienceContinuous improvementTeam managementCollaboration

Required

Bachelor's degree in Life Sciences, Engineering, or a related field

Minimum 7 years of experience in Quality within a regulated pharmaceutical, biologics, or cell therapy environment

2 years of people management experience

Hands-on experience with product complaints, post-market quality surveillance, and recalls or field actions

Experience overseeing external vendors in a regulated Quality environment

Strong knowledge of FDA Quality System and post-market requirements

Proven investigation, CAPA, and inspection-readiness experience

Preferred

Master's degree in Life Sciences, Engineering, or a related field

Company

Capricor Therapeutics, Inc.

Capricor Therapeutics is a publicly traded (NASDAQ: CAPR) biotechnology company with a mission to develop groundbreaking therapies that make a meaningful impact on patients’ lives.

Founded in 2005

Los Angeles, California, USA

51-200 employees