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:
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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 contacted by an official Capricor email address which is @capricor.com. Additionally, Capricor will never ask potential employees to send a check or money to the Company for any reason.

Notice to Recruiting Agencies
Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.