Quality Assurance Manager

Join our dynamic team at Integrated Resources, Inc. as a Quality Control Biochemist. This role is essential in ensuring the quality and safety of our biochemical products. You will engage in rigorous testing and analysis, contributing to the development of innovative solutions in the biotech industry.

We are seeking a passionate and detail-oriented Biochemist to join our dynamic team in San Diego. As a Biochemist, you will be responsible for conducting in-depth research and analysis, developing and implementing innovative biochemical methods, and collaborating with multidisciplinary teams to advance scientific knowledge.Your expertise will be pivotal in driving research projects and optimizing experimental protocols, contributing to groundbreaking discoveries in the field.

About Capricor Therapeutics Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company focused on developing cell and exosome-based therapies for rare diseases. The company’s lead product, Deramiocel (CAP-1002), is in late-stage development for Duchenne muscular dystrophy. Capricor’s StealthX™ exosome platform supports new approaches in targeted delivery systems and vaccinology, with a mission to advance science and deliver new treatments for patients and families facing serious conditions. Role Overview: Quality Control Scientist, Analytical Controls This role is based in San Diego (SD1). The Quality Control Scientist, Analytical Controls, develops, qualifies, and manages analytical control materials for QC assays. The scientist will generate and maintain both positive and negative controls, design and execute analytical studies, and troubleshoot or improve analytical methods used in QC testing. Key Responsibilities Develop and qualify analytical control materials for use in QC assays. Manage the lifecycle of control materials, including ongoing maintenance and documentation. Design and conduct analytical studies to support QC operations. Troubleshoot and refine analytical methodologies as needed for QC testing. Ensure reliability, reproducibility, and regulatory compliance of QC assays. Provide scientific guidance on assay control strategies. Collaborate with teams in Quality Control, Analytical Development, Process Development, Manufacturing, and Quality to support analytical readiness for Capricor’s therapeutic programs. Collaboration This position works closely with multiple teams to ensure analytical controls meet the needs of Capricor’s research and manufacturing efforts. The scientist will contribute expertise to cross-functional projects and help maintain high standards for QC laboratory performance.

We are seeking a meticulous Quality Control Reviewer to join our dynamic team in San Diego. In this vital role, you will ensure that all products meet our quality standards and regulatory compliance before they reach our clients. Your keen eye for detail and analytical skills will help us maintain our commitment to excellence.

We are seeking a detail-oriented and analytical Quality Control Chemist to join our dynamic team in San Diego. In this role, you will be responsible for performing a variety of quality control tests and analyses to ensure that our products meet the highest standards of quality and compliance. You will work closely with other departments to develop and implement quality control protocols and contribute to continuous improvement efforts.

Join our dynamic team at Integrated Resources Inc. as an Entry-Level Biochemist specializing in Protein Conjugation. This role is perfect for recent graduates eager to apply their knowledge in a real-world setting. You will be involved in the development and optimization of protein conjugation processes, contributing to innovative projects that impact health and biotechnology.As a key member of our research team, you will work under the guidance of experienced biochemists and gain hands-on experience with cutting-edge technologies. Your responsibilities will include conducting experiments, analyzing data, and collaborating with cross-functional teams to drive project success.

About Capricor Therapeutics Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company focused on cell and exosome-based therapies for rare diseases. The company’s lead product, Deramiocel (CAP-1002), is in late-stage development for Duchenne muscular dystrophy. Capricor is also advancing its StealthX™ exosome platform to pursue innovations in targeted delivery and vaccinology. Role Overview: Quality Control Associate II, Controls This position is based in San Diego (SD1). The Quality Control Associate II, Controls, supports the development, qualification, and ongoing management of analytical control materials used in quality control assays. The role ensures QC assays remain reliable and consistent by generating, characterizing, and maintaining both positive and negative controls. What You Will Do Generate and maintain analytical control materials, including positive and negative controls for QC assays. Conduct analytical studies to evaluate assay performance. Assist with troubleshooting and optimizing analytical methods used in quality control testing. Collaborate with QC scientists and cross-functional teams to monitor assay performance and support continuous improvement of analytical methods across Capricor’s therapeutic programs. Impact This role is central to maintaining the accuracy and consistency of QC assays, directly supporting Capricor’s mission to deliver new therapies to patients and families affected by rare diseases.

Join our dynamic team at Turner Townsend as a Quality Assurance/Quality Control Inspector specializing in federal projects. In this role, you will be responsible for ensuring that all aspects of construction comply with established standards and regulations. Your keen eye for detail and commitment to quality will contribute significantly to the success of our projects.

Join our team at Capricor Therapeutics as an Analytical Quality Control Specialist, where you will play a crucial role in ensuring the highest quality standards for our innovative therapeutics. You will engage in analytical testing, data analysis, and quality assessments, contributing to our mission of developing breakthrough treatments. We are looking for a detail-oriented individual who excels in a collaborative environment and is passionate about quality assurance in the pharmaceutical industry.

Position Overview:Join our dynamic team as a Quality Control Associate I, where you will engage in both routine and non-routine analysis of incoming products. Utilizing a variety of advanced analyzers and instruments, you will play a key role in supporting the release, characterization, and stability testing of raw materials, production intermediates, and final products.

Capricor Therapeutics (NASDAQ: CAPR) is an innovative biotechnology firm dedicated to pioneering transformative therapies utilizing cell and exosome technology for rare diseases. Our flagship product, Deramiocel (CAP-1002), is in advanced stages of development aimed at treating Duchenne muscular dystrophy. We are also leveraging our proprietary StealthX™ exosome platform to explore new avenues in targeted delivery and vaccinology. Each of our programs underscores our commitment to advancing scientific boundaries and providing life-altering treatments to patients and their families in need.The Quality Control Associate specializing in Environmental Monitoring (EM) is crucial for ensuring optimal environmental conditions necessary for GMP manufacturing. This role involves conducting routine and specialized sampling, analyzing data trends, meticulously documenting results, and ensuring that controlled areas adhere to both regulatory and internal quality standards. As a member of the QC EM team, you will engage in hands-on monitoring of air quality, surfaces, personnel, and testing of water systems and utilities to uphold facility integrity. You will be responsible for maintaining precise, real-time documentation and aiding in investigations of any environmental deviations or anomalies. Collaborating closely with QC, QA, and Production teams, this position ensures that manufacturing and testing environments consistently uphold quality standards to support the production of high-caliber therapeutic products.

Join Capricor Therapeutics, Inc. as a Quality Control Associate II/III, Analytical and contribute to the development of innovative therapies. In this role, you will play a crucial part in ensuring the quality and reliability of our analytical laboratory results.

Join Capricor Therapeutics as a Quality Control Associate III specializing in Sample Management. In this vital role, you will ensure the integrity and quality of sample management processes that support our innovative therapies. You will collaborate with cross-functional teams to uphold the highest standards of quality in our laboratory operations.

Join Eurofins Scientific as a Quality Assurance Manager in San Diego, where you will play a crucial role in ensuring the highest standards of quality and compliance in our laboratory operations. In this dynamic position, you will lead a dedicated team, develop and implement quality assurance programs, and foster an environment of continuous improvement.

Capricor Therapeutics (NASDAQ: CAPR) is a pioneering biotechnology firm committed to the development of groundbreaking cell and exosome-based therapies aimed at addressing rare diseases. Our flagship innovation, Deramiocel (CAP-1002), is currently in late-stage development for Duchenne muscular dystrophy. Additionally, we leverage our proprietary StealthX™ exosome platform to explore new avenues in targeted delivery systems and vaccinology. Each initiative exemplifies our dedication to expanding the frontiers of science and providing transformative treatments to patients and families in urgent need.The Senior Director of Quality Assurance and Quality Systems will spearhead strategic and operational oversight of all quality initiatives supporting Capricor’s clinical-stage and advancing commercial-stage operations. This role holds comprehensive responsibility for the architecture, implementation, and ongoing enhancement of the Quality Management System (QMS), ensuring adherence to regulatory standards, inspection readiness, and robust quality governance throughout development, manufacturing (including cell therapy production), and the prospective commercialization of Deramiocel and StealthX™-based programs.In this critical position, the Senior Director will collaborate closely with executive leadership, Regulatory Affairs, CMC, Clinical, Manufacturing, and other cross-functional teams to facilitate late-stage development, BLA submissions and responses (including managing all quality-related aspects of the Deramiocel pathway), ensuring commercial readiness, and promoting scalable growth while fostering a proactive, risk-based quality culture throughout the organization.

Capricor Therapeutics focuses on developing cell and exosome-based therapies for rare diseases. The company’s lead candidate, Deramiocel (CAP-1002), is in late-stage development for Duchenne muscular dystrophy. Capricor also advances its proprietary StealthX™ exosome platform to pursue new possibilities in targeted delivery and vaccinology. Role overview The Senior Director of Quality leads both strategic and operational quality functions for Capricor’s clinical and commercial-stage activities. This position oversees the design, implementation, and continuous improvement of the Quality Management System (QMS). Ensuring regulatory compliance, inspection readiness, and strong quality governance are central to this role, spanning development, manufacturing (including cell therapy production), and the potential commercialization of Deramiocel and StealthX™-based programs. Key responsibilities Provide leadership for all quality-related activities across the organization. Maintain and enhance the QMS to meet regulatory standards and support inspection readiness. Oversee quality governance for development, manufacturing, and commercialization efforts. Support late-stage development, BLA submissions, and responses, with a focus on quality aspects of Deramiocel. Collaboration This role works closely with executive leadership and teams in Regulatory Affairs, CMC, Clinical, and Manufacturing. The Senior Director of Quality helps drive cross-functional efforts for late-stage development and commercial readiness, while promoting a proactive, risk-based quality culture throughout Capricor.

Join iambic therapeutics as the Director of Quality Systems and Compliance, a pivotal role in shaping our Quality Management System (QMS) to support our innovative clinical development programs and expanding pipeline. This leadership position collaborates with various departments including Regulatory, Medical, Clinical, R&D, and Technology to ensure our quality systems foster innovation, uphold compliance, and maintain readiness for inspections across both U.S. and international clinical initiatives.This position is based in our San Diego headquarters or can be performed remotely within the United States.KEY RESPONSIBILITIESSpearhead the design, implementation, and continuous improvement of the Quality Management System (QMS).Develop policies, procedures, and governance frameworks governing essential quality processes, including document control, change management, deviations, CAPA, training, and risk management.Serve as a strategic quality partner to Regulatory, Medical, Clinical Operations, R&D, and CMC teams.Create and execute a quality roadmap that translates regulatory and quality requirements into scalable operational models, aligned with current compliance needs and future organizational growth.Collaborate with Regulatory and Clinical teams to ensure quality systems effectively support global clinical trial programs, ensuring alignment across regions.Proactively identify and mitigate compliance risks through data-driven monitoring and governance.Establish key quality metrics and dashboards to track system health, compliance trends, and opportunities for continuous improvement.Cultivate a culture of accountability, transparency, and quality ownership throughout the organization.Oversee quality interactions with health authorities, internal audits, and third-party audits as necessary.Ensure inspection readiness for U.S. and global clinical programs through established quality systems, governance, and cross-functional collaboration.QUALIFICATIONSEducation & Experience:Bachelor’s degree in chemistry, biology, engineering, or a related health science.Experience:A minimum of 10 years of progressive experience in Quality Systems, Compliance, and/or Quality leadership within a regulated industry.

The Quality Operations Manager plays a pivotal role in facilitating the transition from outdated paper-based processes to a robust and compliant Electronic Quality Management System (eQMS). This position is essential for ensuring that the Quality System effectively supports all phases of drug development, including nonclinical and clinical development, regulatory submissions (IND, NDA/BLA), commercialization, and product lifecycle management.The Quality Operations Manager is tasked with maintaining compliance with relevant GxP requirements (GLP, GCP, GMP), FDA regulations, global standards, and industry best practices. This role also emphasizes readiness for inspections, regulatory submissions, vendor oversight, and the promotion of a quality-centric culture throughout the organization.Key Responsibilities:eQMS Transition:Evaluate current paper-based procedures and devise a comprehensive plan for transitioning to electronic workflows.Ensure data integrity, compliance with Part 11 where necessary, and proper system validation.Facilitate the integration of GxP processes across all functional areas into a cohesive, risk-based framework.Quality System Management:Develop, implement, and uphold procedures for document control, training management, handling deviations and nonconformances, CAPA, change control, risk management, audit management, and complaint handling (if applicable).Coordinate and deliver training on GxP procedures.Support for External Quality Operations: If applicable.Inspection Readiness & Regulatory Interface:Lead inspection readiness initiatives across the organization.Manage regulatory agency inspections (e.g., FDA, EMA, and other global authorities).Oversee the timely and effective development and implementation of CAPAs in response to regulatory findings.Cross-Functional Leadership:Collaborate with Clinical, Regulatory, CMC, Nonclinical, IT, and Commercial teams.Provide training and foster a culture of quality across the organization.Act as a quality advisor to senior leadership.

Capricor Therapeutics (NASDAQ: CAPR) is a pioneering biotechnology firm dedicated to the development of groundbreaking cell and exosome-based therapies aimed at treating rare diseases. Our flagship innovation, Deramiocel (CAP-1002), is currently in advanced stages of development for Duchenne muscular dystrophy. Additionally, we leverage our proprietary StealthX™ exosome platform to explore novel avenues in targeted drug delivery and vaccinology. Our commitment is clear: to redefine the boundaries of science and provide transformative treatments to patients and families in dire need.The Post-Marketing Product Quality Compliance Manager plays a pivotal role in steering post-market product quality initiatives in alignment with FDA regulations and internal Quality System standards. This position is responsible for leading and nurturing a dedicated team that manages product quality complaints, oversees post-distribution quality monitoring, and implements quality-focused field actions such as recalls and market withdrawals. The manager will provide strategic direction, mentorship, and performance oversight to ensure the timely, compliant, and effective execution of post-market quality processes, promoting a culture of quality and continuous improvement.