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Capricor Therapeutics, Inc. · 3 weeks 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 focused on advancing cell and exosome-based therapies for rare diseases. The Post-Marketing Quality Compliance Associate will conduct internal and external audits to ensure compliance with regulations and standards, collaborating with various departments to drive continuous improvement in quality systems.

BiotechnologyHealth CareMedicalTherapeutics

Responsibilities

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

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

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

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

Inspection Readiness: Support regulatory inspection readiness

Gap Assessments: Assess compliance against regulations and industry standards and recommend improvements

Cross-Functional Partnership: Collaborate with QA/QC, Manufacturing, Regulatory, Supply Chain, and IT to strengthen quality systems

Metrics & Communication: Maintain audit schedules, dashboards, and communicate status and trends to management

Quality Improvement: Support SOP development, training, and continuous improvement initiatives

Additional Support: 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 AuditorData integrityAnalytical problem-solvingStakeholder managementCommunication skillsTime management

Required

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

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)

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

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

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

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

Preferred

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

Vendor Oversight: Experience auditing CMOs/CDMOs and complex supply chains

Digital/Data: Background with data integrity, CSV, Annex 11, and Part 11 assessments

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

Post-Marketing: 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