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Capricor Therapeutics, Inc. · 1 day ago

Post-Marketing Quality Compliance Associate

San Diego, CA

Full-time

Onsite

Entry, Mid Level

$72K/yr - $88K/yr

2+ years exp

Capricor Therapeutics is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. They are seeking a Post-Marketing Quality Compliance Associate to conduct internal and external audits to ensure compliance with applicable regulations and standards, while fostering a culture of continuous improvement.

BiotechnologyHealth CareMedicalTherapeutics

Responsibilities

Plan, conduct, and report risk-based GxP audits across manufacturing, QC, labs, validation, and supply chain

Lead and support vendor audits and monitor ongoing supplier performance, as needed

Develop audit agendas, checklists, and sampling strategies aligned with regulatory expectations

Issue clear audit reports, classify findings, and track CAPA effectiveness to closure

Support regulatory inspection readiness

Assess compliance against regulations and industry standards and recommend improvements

Collaborate with QA/QC, Manufacturing, Regulatory, Supply Chain, and IT to strengthen quality systems

Maintain audit schedules, dashboards, and communicate status and trends to management

Support SOP development, training, and continuous improvement initiatives

Willing to support activities related to post-marketing safety and surveillance and additional responsibilities as needed

Qualification

GMP/GxP auditingFDA 21 CFR knowledgeRisk-based auditingCertified Quality AuditorRoot cause analysisCAPA effectiveness verificationStakeholder managementAnalytical problem-solvingCommunication skillsTime management

Required

Bachelor's degree in a scientific or technical field (e.g., Chemistry, Biology, Engineering) or equivalent experience

2–5 years of auditing experience within biopharma, biotech, medical devices, or related regulated industry, including audits against quality system elements (Deviation, CAPA, Change Control, Training, Document Control)

Working knowledge of FDA 21 CFR Parts 210/211, ICH Q-series, EU GMP, and GxP principles

Strong writing skills and attention to detail; able to produce clear, evidence-based audit reports

Proficiency with risk-based auditing, root cause analysis, and CAPA effectiveness verification

Excellent communication and stakeholder management skills; comfortable engaging at all levels

Preferred

Certified Quality Auditor (CQA) – ASQ, or equivalent certification; candidates without certification must demonstrate the ability and willingness to obtain it within a defined timeframe

Experience auditing CMOs/CDMOs and complex supply chains

Background with data integrity, CSV, Annex 11, and Part 11 assessments

Exposure to biologics, cell & gene therapy, aseptic processing, or sterile manufacturing

Knowledge of ISO 9001/13485 and quality systems related to post-marketing safety and surveillance (as applicable)

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