Quality Operations Manager (GMP)

The Quality Operations Manager plays a pivotal role in facilitating the transition from outdated paper-based processes to a robust and compliant Electronic Quality Management System (eQMS).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, regul…

Join Sobi as an External Quality Operations Manager specializing in Good Manufacturing Practices (GMP). In this pivotal role, you will oversee quality operations, ensuring compliance and excellence within our external partnerships. Your leadership will drive quality assurance and operational efficiency, fostering a culture of continuous improvement.

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.

The Quality Assurance Manager is responsible for overseeing the quality control processes and ensuring that all project deliverables meet established standards and client expectations. This role involves developing and implementing quality assurance strategies, conducting audits, and collaborating with project teams to address quality-related issues.

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.

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.

Capricor Therapeutics (NASDAQ: CAPR) is an innovative biotechnology company committed to pioneering transformative cell and exosome-based therapies for rare diseases. Our leading innovation, Deramiocel (CAP-1002), is currently in late-stage development for Duchenne muscular dystrophy. Additionally, we are leveraging our proprietary StealthX™ exosome platform to explore new avenues in targeted delivery and vaccinology. Each of our programs exemplifies our dedication to advancing scientific boundaries and providing life-altering treatments to patients and families in need.The Director of Quality Assurance and Quality Systems will spearhead and facilitate quality assurance and quality systems initiatives across Capricor’s biotechnology operations, both clinical and commercial. This pivotal role will enhance the company's Quality Management System, ensure inspection readiness, and guarantee that quality processes are scalable, compliant, and in alignment with late-stage development and commercial launch. The ideal candidate will possess extensive hands-on experience in QA and Quality Systems, a deep understanding of GMP and FDA regulations, and a proven track record of fostering cross-functional collaboration to build a proactive, risk-based quality culture.

Join Capricor Therapeutics, a pioneering biotechnology firm dedicated to revolutionizing cell and exosome-based therapies for rare diseases. At the heart of our innovation is Deramiocel (CAP-1002), our flagship cell therapy currently in late-stage development for Duchenne muscular dystrophy. We are also leveraging our proprietary StealthX™ exosome platform to explore new frontiers in targeted delivery and vaccinology. Our commitment is to push the boundaries of science and deliver life-altering treatments to patients and families in need.

As the Quality Assurance Manager for Good Clinical Practice (GCP) at Sobi, you will play a pivotal role in ensuring the highest standards of quality oversight, assurance, and design within the GCP/GCLP domains. Your responsibilities will include:Overseeing quality assurance and design activities related to GCP/GCLP.Providing guidance and support on GCP/GCLP and GPP-related activities throughout Sobi, including audits, inspections, and risk assessments associated with BLA/NDA/IND/CTA submissions globally.Facilitating the collection of data necessary for the audit program risk assessment.Supporting clinical study-related quality activities across Sobi.Ensuring the qualification of global and local ESP in GCP regulated areas according to Sobi procedures.Collaborating with relevant stakeholders across the Sobi organization.Key Responsibilities:Manage the GCP audit process to ensure excellence throughout the audit lifecycle.Assess and approve GCP deviations and related CAPAs from a quality perspective.Prepare regular status reports on audits, trending deviations, and CAPAs to uphold quality oversight.Contribute to GCP audit risk assessments according to SOPs.Actively engage with cross-functional teams on GxP and Quality requirements, ensuring proper qualification of GCP service providers.Serve as the QA representative during GCP inspections and promote a continuous quality mindset across Sobi.Develop and review GCP QA-related processes under the global framework.

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.

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.

Capricor Therapeutics (NASDAQ: CAPR) is a pioneering biotechnology firm focused on developing groundbreaking cell and exosome-based therapies for rare and challenging diseases. Leading our innovations is Deramiocel (CAP-1002), our principal cell therapy currently in advanced stages of development for Duchenne muscular dystrophy. Additionally, we are leveraging our proprietary StealthX™ exosome platform to explore new avenues in targeted delivery and vaccinology. Each of our initiatives embodies our dedication to advancing scientific frontiers and providing transformative treatments to patients and families in critical need.We are in search of a proactive and meticulous Facilities Associate II / III to oversee and enhance GMP facility operations. This role entails independently managing equipment calibration and maintenance programs, coordinating intricate vendor activities, and actively participating in continuous improvement initiatives across our facilities and compliance systems. The ideal candidate will possess valuable hands-on GMP experience, exercise sound judgment in a regulated environment, and demonstrate initiative in addressing operational challenges. This position is based at our headquarters in San Diego, CA.

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.

Join the Art of Problem Solving (AoPS) as a Grading Operations Manager, where you will play a vital role in overseeing our grading processes. This position will require a detail-oriented individual who can manage multiple tasks efficiently while ensuring that our grading standards remain exemplary.Your responsibilities will include coordinating with grading teams, implementing processes for quality assurance, and ensuring timely feedback for our students. Your expertise will help us maintain our commitment to excellence in education.

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.

The Assistant Bakery Operations Manager (ABOM) is a pivotal leadership role aimed at grooming the next generation of Bakery Operations Managers. ABOMs are designed to operate at a level that mirrors that of a Bakery Operations Manager (BOM), executing bakery operations with a focus on urgency, precision, and accountability while honing the leadership skills essential for managing a bakery independently.This role seamlessly integrates hands-on operational excellence with talent development, administrative responsibilities, and team leadership. ABOMs serve as a vital extension of the BOM, demonstrating the capability to take full ownership of bakery operations when necessary. Our San Diego store is conveniently located at 3066 E. University Ave., San Diego, CA 92104.KEY RESPONSIBILITIES:Operational Execution• Oversee all fundamental bakery operations, including inventory management, staff scheduling, and adherence to administrative protocols.• Ensure compliance with product quality, cleanliness, food safety, and guest experience standards.• Assist in inventory ordering, accuracy, and loss prevention strategies.• Help create schedules and manage labor execution to achieve operational goals.Talent & Team Development• Assist in the recruitment, interviewing, onboarding, and training of new team members.• Provide consistent coaching and immediate performance feedback.• Hold team members accountable to established standards while promoting a culture of growth.• Ensure that onboarding and training initiatives align with company standards.Leadership & Ownership• Manage bakery operations independently in the absence of the BOM.• Exemplify urgency, accountability, and operational discipline.• Collaborate with BOM and Area leadership to identify and resolve operational gaps.• Maintain operational continuity during leadership transitions or staffing shortages.• Perform additional duties as required.WHAT SUCCESS LOOKS LIKE:• Capable of executing all BOM-level administrative and operational tasks independently.• The bakery operates at full staffing levels, with a well-trained team adhering to high standards.• A strong culture of accountability and consistency is established.• Acts as a dependable operational leader during any coverage scenario.• Clearly demonstrates readiness and upward mobility towards a BOM role.QUALIFICATIONS & EXPERIENCE:• Minimum of 1 year of leadership experience in restaurant, retail, or hospitality operations.• Strong operational discipline and keen attention to detail.• Proven ability to coach and develop hourly team members.• Comfort in fast-paced, high-volume environments.• Capability to perform all bakery roles during peak business periods.• Excellent communication and problem-solving skills.

Join the team at Insomnia Cookies as an Assistant Bakery Operations Manager (ABOM) in our vibrant San Diego Gaslamp location! This pivotal leadership role is designed to cultivate future Bakery Operations Managers, allowing you to hone your skills in operational excellence and team leadership. As an ABOM, you will be responsible for executing bakery operations with precision and a sense of urgency, while also developing the leadership capabilities necessary to manage a bakery independently.In this dynamic position, you will blend hands-on operational responsibilities with administrative management and team development. Acting as a vital extension of the Bakery Operations Manager (BOM), you will be prepared to step into full bakery ownership whenever required. Our San Diego store is situated at 542 Fifth Avenue, San Diego, CA 92101.KEY RESPONSIBILITIES:Operational Execution• Oversee all core bakery operations including inventory management, scheduling support, staffing coordination, and administrative tasks.• Uphold stringent standards for product quality, cleanliness, food safety, and guest experience.• Aid in ordering processes, maintaining inventory accuracy, and minimizing shrinkage.• Assist in developing schedules and executing labor plans to achieve operational objectives.Talent & Team Development• Participate in the recruitment, interviewing, onboarding, and training of new team members.• Provide consistent coaching and immediate performance feedback to staff.• Hold team members accountable to operational standards while fostering a culture of growth and development.• Ensure the successful execution of onboarding and training programs in alignment with company standards.Leadership & Ownership• Independently manage bakery operations in the absence of the BOM.• Demonstrate urgency, accountability, and operational discipline.• Collaborate with the BOM and area leadership to identify operational gaps and implement effective solutions.• Ensure continuity of operations in situations involving leadership transitions or staffing shortages.• Undertake additional duties as assigned.WHAT SUCCESS LOOKS LIKE:• Proficiently execute all BOM-level administrative and operational tasks independently.• Maintain a fully staffed, trained, and high-performing bakery.• Establish a strong culture of accountability and operational consistency.• Serve as a dependable operational leader during coverage scenarios.• Exhibit clear readiness and potential for advancement to a BOM role.QUALIFICATIONS & EXPERIENCE:• Minimum of 1 year of leadership experience in restaurant, retail, or hospitality operations.• Strong operational discipline and keen attention to detail.• Proven ability to coach and develop hourly team members.• Comfortable and effective in fast-paced, high-volume environments.• Capable of performing all bakery roles during peak business periods.• Excellent communication and problem-solving skills.

Capricor Therapeutics (NASDAQ: CAPR) is a pioneering biotechnology firm dedicated to the advancement of innovative cell and exosome-based therapies aimed at treating rare diseases. Our flagship product, 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 and vaccinology, reflecting our unwavering commitment to pushing the limits of science and providing transformative treatments to patients and families in need.The Operations Coordinator plays a crucial role in ensuring the seamless operation, safety, and professionalism of our workplace. This position is responsible for maintaining an organized, clean, and compliant environment across office, lab-adjacent spaces, and common areas. This individual will conduct regular facility inspections to monitor workplace conditions, provide support to employees and visitors, and coordinate with facilities, security, and vendors to address any issues promptly. In our dynamic biotech setting, this role is highly visible and integral to fostering a productive, safe, and welcoming work environment.

Join Moveworks as a Senior Sales Enablement Manager, where you'll play a critical role in enhancing our content and learning operations. Your expertise will empower our sales teams with the tools, resources, and training they need to excel in their roles. You will collaborate closely with various departments to create impactful learning experiences that drive sales performance and customer satisfaction.