Key Responsibilities
Plan, execute, and report on internal audits of GxP processes (e.g., GMP manufacturing, QC, validation, laboratories, supply chain).
Lead or support supplier/vendor audits and monitor ongoing supplier performance.
Prepare detailed audit agendas, checklists, and sampling strategies aligned with risk and compliance priorities.
Document findings clearly; issue audit reports with classifications, evidence, and actionable recommendations.
Track and verify effectiveness of CAPAs (Corrective and Preventive Actions) and drive timely closure.
Support inspection readiness activities and host/liaise during regulatory inspections (e.g., FDA, EMA, MHRA).
Perform gap assessments against current regulations and industry standards; propose reasonable improvements.
Collaborate with QA/QC, Manufacturing, Regulatory, Supply Chain, and IT to strengthen quality systems.
Maintain audit schedules, metrics, and dashboards; communicate status to stakeholders and management.
Contribute to policy/SOP development, training, and continuous improvement initiatives.
Minimum Qualifications
Bachelor's degree in a scientific or technical field (e.g., Chemistry, Biology, Engineering) or equivalent experience.
1-2 years of auditing experience within biopharma, biotech, medical devices, or related regulated industry.
Working knowledge of FDA 21 CFR Parts 210/211, ICH Q-series, EU GMP, and GDP principles.
Experience performing audits against quality system elements (Deviation, CAPA, Change Control, Training, Document Control).
Strong technical 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 Qualifications
Certified Quality Auditor (CQA) – ASQ, or equivalent certification.
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, 21 CFR 210/211, and pharmacovigilance quality systems (as applicable).
Why Capricor?
Capricor Therapeutics is advancing cell and exosome-based therapies with a focus on serious diseases where patients and families need new treatment options. Our work is grounded in scientific rigor, collaboration, and a shared commitment to moving meaningful therapies forward. Joining Capricor means being part of a mission-driven team working at the intersection of innovation, execution, and patient impact.
Come Work With Us
At Capricor, you’ll join a collaborative environment where employees are encouraged to contribute, grow, and help build the systems, science, and operations needed to support our next stage of growth. We value people who are thoughtful, accountable, hands-on, and motivated by work that can make a real difference.
Recruiting Fraud Notice
Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by someone using an official Capricor email address ending in @capricor.com. Capricor will never ask candidates to send money, deposit a check, purchase equipment, or provide payment for any reason as part of the recruiting or onboarding process.
Notice to Recruiting Agencies
Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without express written approval from Talent Acquisition and a fully executed agreement with Capricor. Agencies that contact hiring managers directly, solicit business, or submit candidates without prior approval will not be considered for engagement. Any unsolicited submissions will become the property of Capricor Therapeutics, and no fees will be paid for candidates hired as a result of such submissions. We appreciate your cooperation and respect for this policy.
Skills Required
- Bachelor's degree in a scientific or technical field or equivalent experience.
- 1-2 years of auditing experience within biopharma, biotech, medical devices, or regulated industry.
- Working knowledge of FDA 21 CFR Parts 210/211, ICH Q-series, EU GMP, and GDP principles.
- Experience performing audits against quality system elements (Deviation, CAPA, Change Control, Training, Document Control).
- Strong technical 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.
- Certified Quality Auditor (CQA) - ASQ, or equivalent certification.
- 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 pharmacovigilance quality systems.
What We Do
Capricor Therapeutics is a clinical-stage biotechnology company focused on the discovery, development, and commercialization of cell and exosome-based therapeutics. Its lead product candidate, Deramiocel, is an allogeneic cell therapy currently in late-stage clinical development for the treatment of Duchenne muscular dystrophy (DMD). The company also leverages its proprietary StealthX™ exosome platform for the targeted delivery of therapeutic agents to treat a wide range of diseases.
