Capricor Therapeutics
Director, Quality Assurance & Quality Systems
San Diego, CA · Director
Sponsorship not specified$175k-$215kDetected 29 days ago
ExpressData AnalysisSupply ChainRecruitingPerformance ManagementGMPFDA RegulatoryCRISPRMedical DevicesLeadershipCommunicationCollaborationProblem SolvingPublic SpeakingRegulatory Affairs
About the role
- Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases.
- Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most.
- Capricor Therapeutics is advancing cell and exosome-based therapies with a focus on serious diseases where patients and families need new treatment options.
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)
- 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
- Support the preparation and execution of internal audits, including regulatory inspections, to ensure compliance with regulatory requirements
- 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
Requirements
- 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
- 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
- Experience managing regulatory inspections and audit readiness programs
- 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 have
- Bachelor's degree in Life Sciences, Engineering, or a related field (Master's degree preferred)
Compensation
- $175k-$215k
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