Job Description

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 Quality Systems Associate will support and maintain Capricor’s Quality Management System (QMS) to ensure compliance with FDA, GMP, ISO 9001, and internal quality standards. This role will assist in document control, training, audit preparation, quality records management, and system administration while collaborating across functional teams to strengthen Capricor’s quality operations.

This is an excellent opportunity for someone who is detail‑oriented, organized, and eager to grow their quality career in a fast‑paced biotech environment.

Responsibilities

• Support maintenance and continuous improvement of the Quality Management System (QMS) according to FDA, GMP, and ISO 9001 requirements.
• Assist in document control activities, including creation, revision, routing, issuance, and archival of controlled documents.
• Help manage and track corrective and preventive actions (CAPA) to ensure timely investigation, follow up, and closure.
• Assist in preparing for internal audits; support readiness for external audits and inspections.
• Coordinate and track employee training activities to ensure staff remain compliant and current with required qualifications.
• Support management of deviations, non conformances, and audit findings, ensuring documentation is accurate and complete.
• Support the implementation and maintenance of change control processes and records by collaborating with change owners to ensure changes are properly documented, justified, reviewed, and approved.
• Coordinate cross-functional collaboration for change control assessments, reviews, and approvals, and serve as the facilitator for Change Control Review Board meetings.
• Collaborate with cross functional teams (QA, QC, Manufacturing, Facilities, R&D) to support quality system activities and improvements.
• Help generate, analyze, and maintain quality metrics and trend reports to support continuous improvement.
• Assist with the administration of quality system software, including user access management, record maintenance, and troubleshooting.
• Stay informed on evolving regulations, guidance documents, and industry best practices.
• Perform other duties and responsibilities as assigned to support departmental and organizational objectives.

Required Skills

• Bachelor’s degree in Life Sciences, Engineering, or a related field.
• Minimum 2+ years of experience in quality systems, quality assurance, or quality operations within a regulated industry (pharmaceuticals, biologics, medical devices, etc.).
• Knowledge of FDA regulations, GMP guidelines, and ISO 9001 standards.
• Experience supporting CAPA processes, deviations, and change controls.
• Strong attention to detail and organizational skills to be able to successfully manage/review multiple records at once.
• Ability to work independently and collaboratively in a fast paced environment.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint).
• Experience with QMS or electronic quality system software platforms (QT9/Veeva preferred).
• Strong written and verbal communication skills for effective cross functional collaboration.

Preferred / Nice-to-Have Skills

• Experience in a GMP manufacturing, biologics, or cell therapy environment.
• Exposure to ISO audit practices or participation in internal audits.
• Ability to analyze quality data, produce reports, and identify trends.

Work Environment / Physical Demands

• Primarily office based, focusing on quality system management and documentation activities.
• Requires prolonged periods of computer use for documentation, reporting, and system administration.
• Occasional lifting of office materials up to 15 pounds.
• Ability to move between office and operational areas to support audits and cross functional work. 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.