Quality Assurance Manager, GCP at Sobi | San Diego

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 …

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.

The Quality Operations Manager plays a pivotal role in facilitating the transition from outdated paper-based processes to a robust and compliant Electronic Quality Management System (eQMS).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

Join our team as a Quality Assurance Associate, where you'll play a crucial role in ensuring the functionality and reliability of our innovative hiring software. This position involves meticulous testing within Lever's testing environment, which is pivotal for continuous improvement and enhancement of our products.At Lever, we have redefined the talent acquisition landscape, partnering with industry leaders such as Netflix, Shopify, and Cirque du Soleil. Our commitment to fostering a people-first culture and investing in our employees has earned us accolades as one of the best workplaces in the U.S. We are excited to expand our team with dedicated individuals who are passionate about quality and excellence.

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 an innovative biotechnology firm committed to pioneering 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 are leveraging our unique StealthX™ exosome platform to explore new avenues in targeted drug delivery and vaccine development. Every initiative at Capricor embodies our dedication to advancing scientific boundaries and providing transformative therapies for patients and their families.We are looking for a dedicated Quality Assurance Associate II to enhance our team. This pivotal role focuses on scaling our clinical production activities while ensuring adherence to cGMP and regulatory standards. The ideal candidate will assist in batch record reviews, deviation investigations, label issuance, and the management of controlled documents across GLP/GCP/GMP systems. We seek an individual who is detail-oriented, organized, and driven to achieve quality excellence in a dynamic environment.

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.

Join Sobi as an Associate Director of CMC / Technical Operations Program Management, where you will lead and oversee critical technical programs that drive our commitment to delivering innovative therapies. In this pivotal role, you will collaborate with cross-functional teams to ensure seamless integration of our technical operations and contribute to the advancement of our product pipeline.

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.

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.

Agile Defense seeks an Information Assurance Specialist in San Diego, CA. The team values proactive problem-solving and adapts quickly to changing needs. This position supports efforts to protect and strengthen critical national operations. Role overview This role focuses on integrating new technologies and approaches to help secure national interests. Collaboration with skilled colleagues and a commitment to continuous improvement are central to the work. What you will do Contribute to projects that safeguard critical operations Apply creative thinking and adaptability to address security challenges Work within a team dedicated to innovation and agility Location This position is based in San Diego, CA.

Ensure adherence to all relevant local and international pharmaceutical regulations.Lead Quality Chemistry, Manufacturing, and Controls (CMC) operations, overseeing batch disposition, manufacturing, packaging, labeling, and testing to guarantee product integrity and timely material release.Provide decisive leadership to enhance quality-related processes including batch disposition, investigations, analytical data reviews, supply chain management, and risk assessment.Act as the primary contact for complex and high-stakes quality challenges and resolutions.Proactively assess and manage quality risks throughout the product lifecycle, recommending and implementing effective mitigation strategies.Collaborate closely with ORIC's technical operations team, Contract Manufacturing Organizations (CMOs), contract testing labs, and distribution centers to ensure rigorous quality reviews of all process and analytical data, supporting informed program decisions.Work synergistically with Regulatory Affairs to facilitate timely and precise submission reviews.Engage actively with clinical program teams, contributing to clinical development meetings to ensure ongoing quality support.Design and implement performance-driven quality metrics and trend analyses to foster continuous improvement.Conduct and present Annual Product Reviews for advanced-stage programs.Lead, mentor, and cultivate a high-performing Quality team, scaling effectively to support transitions from clinical to commercial phases.Serve as Chair or a key member of various governance committees, including ORIC’s Stability Review Board, Material Review Board, and Change Review Board.Represent ORIC Quality in discussions with CDMOs, regulatory authorities, and strategic leadership meetings as required.Exhibit a high degree of adaptability in fast-paced environments, adjusting strategies and priorities according to evolving business needs, technologies, and stakeholder expectations.Develop new functional Standard Operating Procedures (SOPs), policies, and plans for late-phase and commercial readiness as required.

Join our dynamic team at Integrated Resources, Inc. as a Quality Assurance Specialist focused on the pharmaceutical industry. In this role, you will play a crucial part in ensuring the highest quality standards in the development and manufacturing of pharmaceutical products. Your expertise will help maintain compliance with regulatory requirements and enhance product safety and effectiveness.

Join 360 IT Professionals as an Automation Quality Assurance Engineer (SDET) in San Diego, where you'll play a crucial role in enhancing software quality through automated testing. We are seeking a detail-oriented and proactive individual to develop and implement automated tests that ensure the functionality and performance of our software products.

Oric Pharmaceuticals is seeking a Director of Clinical Quality Assurance to lead our quality assurance efforts. This pivotal role will involve developing and implementing robust quality systems that comply with regulatory standards. As a key player in our clinical operations, you will ensure the integrity of our clinical trials and contribute to the overall success of our drug development programs.

Join our dynamic team at StemXpert as a Quality Assurance Specialist! In this full-time role, you will play a critical part in ensuring the highest standards of quality in our products. Your keen eye for detail and commitment to excellence will help us maintain our reputation for delivering outstanding solutions to our clients. You will collaborate with cross-functional teams to identify areas for improvement and implement effective testing procedures. If you are passionate about quality assurance and eager to contribute to innovative projects, we would love to hear from you!

San Diego Harley-Davidson, a Sonic Automotive dealership, is hiring a General Manager to lead daily operations in San Diego. This leadership role centers on team management, customer satisfaction, and reaching sales targets in a competitive local market. Key Responsibilities Direct all dealership operations, ensuring smooth day-to-day performance Coach and support staff to help them reach their potential Uphold high standards for the customer experience Work to make the dealership a standout presence in San Diego Requirements Strong skills in strategic planning and operational management Experience leading teams, preferably in automotive or motorcycle settings Dedication to customer satisfaction Authentic interest in the motorcycle industry

Join Equinox as a Maintenance Manager in San Diego, where you will play a pivotal role in maintaining our state-of-the-art facilities. Your expertise will ensure that our equipment and operations run smoothly, providing a premium experience for our members.You will lead a dedicated team, overseeing maintenance schedules, conducting inspections, and managing repairs. Your proactive approach will help us uphold the highest standards of safety and quality in our facilities.

Join Sobi as a pivotal leader in our Manufacturing Science and Technology team. As the Drug Product Lead, you will spearhead the development and implementation of innovative drug manufacturing processes, ensuring high-quality standards and compliance with regulatory requirements. This role is integral to advancing our product pipeline and enhancing operational efficiencies.