Director, Quality Assurance & Quality Systems

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 Director, Quality Assurance & Quality Systems will lead and support quality assurance and quality systems activities for Capricor's clinical and commercial-stage biotechnology operations. The role advances the company's Quality Management System, drives inspection readiness, and ensures quality processes are scalable, compliant, and aligned with late-stage development and commercial launch. The ideal candidate brings hands-on QA and Quality Systems experience, deep knowledge of GMP and FDA requirements, and a proven ability to partner cross-functionally to build a proactive, risk-based quality culture.

Responsibilities:
Quality Assurance & Quality Systems Leadership

• Lead and manage the QA/QS team, ensuring alignment with company objectives and regulatory standards

• Develop, implement, and maintain quality management strategies and systems to ensure compliance with GMP, FDA, ICH guidelines, and other relevant regulatory bodies

• Design, establish, and continuously improve the Quality Management System (QMS), including document control, change control, training systems, and electronic quality systems (eQMS)

Quality Systems Management

• Oversee the entire quality systems infrastructure, including Standard Operating Procedures (SOPs), batch records, specifications, and validation protocols

• Manage document lifecycle management ensuring version control, approval workflows, and archival in compliance with regulatory requirements

• Establish and maintain quality metrics dashboards and Key Performance Indicators (KPIs) for system effectiveness

Compliance & Regulatory

• Establish and enforce quality assurance policies and procedures across all operational departments

• Support the preparation and execution of internal audits, including regulatory inspections, to ensure compliance with regulatory requirements

• Ensure timely resolution of quality-related issues, including non-conformances, deviations, and CAPA (Corrective and Preventive Actions)

• Maintain inspection readiness and serve as primary QA point of contact for regulatory inspections

Cross-Functional Collaboration & Lifecycle Management

• Collaborate with cross-functional teams (R&D, manufacturing, regulatory affairs, supply chain, etc.) to ensure product quality throughout the entire lifecycle

• Partner with Regulatory Affairs to support CMC sections of regulatory submissions (IND, BLA, NDA)

• Support technology transfer activities and new product introductions from a quality systems perspective

Continuous Improvement & Risk Management

• Lead continuous improvement initiatives leveraging methodologies to enhance product quality, manufacturing processes, and operational efficiency

• Provide leadership in Quality Risk Management (QRM), including identification, assessment, and mitigation of quality risks using ICH Q9 principles

• Champion a culture of quality throughout the organization

Performance Management & Reporting

• Prepare and present quality performance metrics, trending analysis, and reports to senior management and board of directors

• Mentor and develop QA/QS staff, fostering a culture of accountability, compliance, and continuous professional growth

Requirements:
Education & Experience

• Bachelor's degree in Life Sciences, Engineering, or a related field (Master's degree preferred)

• 10+ years of progressive experience in Quality Assurance and Quality Systems, with at least 5 years in a leadership role within a regulated industry (pharmaceutical, biotechnology, or medical devices)

• Direct experience in cell and gene therapy or advanced therapeutic products is highly desirable

Technical Knowledge

• Strong knowledge of regulatory requirements, including FDA, GMP, ICH guidelines, ISO 13485, and 21 CFR Parts 210, 211, 600, 820, and 1271

• Demonstrated expertise in Quality Management Systems (QMS) design, implementation, and maintenance

• Proven experience with electronic quality systems (eQMS) platforms (e.g., Veeva, MasterControl, TrackWise, or similar)

• Knowledge of Quality Risk Management methodologies (ICH Q9, FMEA, etc.)

Leadership & Management

• Proven experience leading quality assurance and quality systems teams and managing cross-functional collaborations

• Demonstrated ability to drive process improvements and manage complex quality systems in dynamic environments

• Experience managing regulatory inspections and audit readiness programs

Skills & Competencies

• Excellent problem-solving, analytical, and decision-making skills

• Strong written and verbal communication skills, with the ability to interact with senior leadership, regulatory agencies, and external stakeholders

• Experience in preparing and presenting reports and metrics to senior management and board members

• Strong leadership and interpersonal skills, with the ability to mentor and guide teams towards excellence

• Ability to work effectively in a fast-paced, entrepreneurial environment with changing priorities

Work Environment / Physical Demands:
• Primarily office-based with required time in GMP spaces addressing quality management and audits.

• Requires prolonged periods of computer use for documentation, data analysis, and report generation related to quality processes.

• May involve lifting office materials or equipment up to 10 pounds.

• Ability to navigate office and GMP environments for audits and oversight.

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.