Post-Marketing Quality Compliance Associate

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.

We are seeking an individual to join our Quality Compliance department. This role conducts internal and external audits to ensure our biopharma operations comply with applicable regulations, standards, and company procedures. The ideal candidate brings hands-on GMP/GxP auditing experience within the life sciences industry and partners cross-functionally to drive continuous improvement and a strong culture of compliance.

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.

Minimum Qualifications:
• 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 Qualifications:
• 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).

Core Competencies:
• Integrity & objectivity in evidence gathering and reporting.
• Risk-based thinking and prioritization.
• Analytical problem-solving and pragmatic recommendations.
• Collaboration across functions and suppliers.
• Time management, organization, and follow-through.

Work Conditions:
• On site based in San Diego.
• Occasional travel for supplier audits.

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.