Director, Quality Assurance & Quality Systems

Capricor Therapeutics•San Diego, CA

4d•Hybrid

About The Position

Capricor Therapeutics is a biotechnology company focused on developing cell and exosome-based therapies for rare diseases. 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. This role is responsible for advancing the company's Quality Management System, ensuring inspection readiness, and guaranteeing that quality processes are scalable, compliant, and aligned with late-stage development and commercial launch. The ideal candidate will possess hands-on QA and Quality Systems experience, a thorough understanding of GMP and FDA requirements, and a demonstrated ability to collaborate cross-functionally to foster a proactive, risk-based quality culture.

Requirements

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
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.)
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
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

Nice To Haves

Master's degree

Responsibilities

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)
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
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
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
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
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