Director of Quality Systems and Compliance

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 qual…

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 (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 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 Capricor Therapeutics as a Quality Systems Associate II, where you'll play a vital role in ensuring the integrity and compliance of our quality systems. This position offers the opportunity to work alongside a talented team committed to advancing innovative therapeutic solutions.

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.

Role Overview Platform Science is seeking a Director of Business Systems to guide the strategy, architecture, and operations of our NetSuite and Salesforce environments. This leadership position reports to the VP of IT and can be based remotely within the Pacific Time Zone or in San Diego, CA. About Platform Science Founded in 2015, Platform Science builds an open IoT platform for the transportation industry. Our teams work alongside fleets, application developers, vehicle manufacturers, and equipment providers to deliver solutions that help supply chain professionals worldwide. We value diverse perspectives, empathy, and transparent collaboration across all roles. What You Will Do Lead the global NetSuite and Salesforce ecosystems, setting vision and strategy for these platforms. Oversee systems architecture and drive process improvements across business functions. Manage the full lifecycle of business systems, from planning through administration and optimization. Supervise and mentor a distributed team of administrators and analysts. Act as subject matter expert for NetSuite and Salesforce, especially in the Lead-to-Cash process. Oversee related systems and processes, including CPQ, CLM, AR/AP automation, PLM, and billing. Collaborate with executive stakeholders to align technology initiatives with business goals. Location This role is open to candidates in the Pacific Time Zone, with the option to work remotely or from our San Diego, CA office.

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.

AECOM is seeking a dedicated and detail-oriented Special Systems Inspector to join our team in San Diego, California. In this role, you will play a critical part in ensuring the quality and compliance of specialized systems within various projects. Your expertise will contribute to the successful execution of our projects and the overall satisfaction of our clients.As a Special Systems Inspector, you will be responsible for conducting thorough inspections, documenting findings, and collaborating with project teams to resolve any issues. Your role is crucial in maintaining our high standards and delivering exceptional results.

Join Capricor Therapeutics as a Corporate Compliance Officer and play a vital role in ensuring that our organization adheres to all regulatory requirements and internal policies. In this position, you will be responsible for developing, implementing, and monitoring compliance programs that foster a culture of ethics and integrity. You will collaborate with various departments to provide guidance and support in compliance-related matters, ensuring that our practices align with industry standards.

Who We AreAt Stealth Fintech, we are committed to transforming the landscape of ERP-native B2B payments. As a well-backed early-stage startup operating in stealth mode, we are developing innovative solutions designed to redefine how businesses transact. If you are passionate about addressing significant challenges from the ground up, we invite you to join our team. Led by visionary founders, we are focused on building modern infrastructure for B2B payments that empowers enterprises to leverage their ERP systems for swift, transparent, and controlled payment processes, whether it’s paying suppliers, card issuers, or reimbursing employees globally.About the PositionWe are in search of a Payments Compliance Analyst to enhance our compliance program tailored for enterprise clients making payments to vendors and suppliers worldwide. In this role, you will facilitate compliance operations related to onboarding and payment monitoring, collaborating closely with our regulated payment partners. Our platform integrates within ERP and finance systems, allowing enterprises to automate accounts payable and supplier payments across borders. Your primary focus will be on managing supplier risk at scale, ensuring compliance in onboarding and payment execution while supporting complex workflows for large enterprises.Your Key ResponsibilitiesSupport compliance for enterprise vendor and supplier payment flows, involving high-value and recurring payments, which includes:Conducting Know Your Business (KYB) and customer due diligence for enterprise clients.Performing fraud and sanctions screening for both domestic and international vendors, suppliers, and contractors.Conduct transaction monitoring and investigations for global supplier payments.Review risks associated with sanctions, embargoes, and adverse media, specifically concerning:Supplier jurisdictions.Counterparties and beneficial owners.Assist with Suspicious Activity Report (SAR) and Suspicious Transaction Report (STR) filings, regulatory reporting, and internal escalations.Collaborate with Product, Engineering, and ERP integration teams to:Embed compliance controls within accounts payable and supplier workflows.Support the integration of new payment rails, currencies, countries, and supplier types.

Join Our Dynamic Team!At DSI Systems, we leverage over 40 years of expertise in sales enablement and tailored business solutions, providing unparalleled value that drives success for our clients and partners. We are actively seeking enthusiastic individuals who are ready to leave their mark in the realms of sales and customer service. Our vibrant and fulfilling workplace offers a platform for you to grow alongside us and make a meaningful contribution.Position OverviewThe Retail Support Specialist (RSS) is pivotal in delivering direct, hands-on assistance to AT&T customers within bustling national retail settings. In this role, you will directly interact with customers and retail partners to address account issues, billing inquiries, device assistance, and service-related concerns, often in high-pressure, fast-paced environments. To succeed, you must possess excellent communication skills, emotional fortitude, a knack for technology, and the ability to maintain composure, accuracy, and professionalism amidst the dynamic nature of retail.Key Responsibilities:Customer SupportDeliver professional, friendly, and solution-oriented support to AT&T customers in national retail locations.Handle inquiries regarding billing, account modifications, plan adjustments, device troubleshooting, and service issues.Diagnose and resolve wireless device issues, network challenges, and feature functionality queries.Thrive in high-volume retail settings, upholding focus, professionalism, and service excellence during peak times and escalated situations.Retail Partner SupportServe as the AT&T subject-matter expert for retail staff and third-party labor partners.Act as the primary AT&T representative for these partners, leading in-store support for retail escalations.Engage proactively with store management to address customer concerns, enhancing partnership alignment and ensuring a top-tier customer experience.Work Environment & Schedule Expectations:This role is conducted in a retail environment and necessitates standing, walking, and engaging with customers on the sales floor for up to 8 hours daily.Willingness to work flexible hours, including evenings, weekends, and holidays, based on business needs.Comfort in busy, customer-facing environments requiring frequent interaction and problem-solving.Operational Excellence:Effectively navigate multiple systems while interacting with customers in real-time.Thoroughly document all interactions with precision.Adhere to company policies, compliance mandates, and privacy standards.Achieve or surpass performance metrics, including quality, efficiency, and customer satisfaction ratings.Execute and maintain approved planograms for mobile devices and signage.

Key ResponsibilitiesFacilitate review processes to guarantee that complaints align with regulatory standards as well as corporate policies and procedures.Collaborate with MMS complaint handling sites to maintain uniformity in complaint documentation and to implement solutions and process improvements whenever feasible.Ensure that appropriate corrective actions are initiated when necessary. Take ownership of or assist with internal audits and CAPA actions related to complaint documentation and/or adverse event reporting.Engage in the planning and execution of complaint record remediation as required.Work alongside other quality professionals to resolve complaint-related issues identified across the organization.Exemplify the principles of the BD WAY, which include our standards of behavior, leadership commitments, and the mindset we apply to our work.May coordinate activities with others and/or undertake additional related responsibilities as assigned regarding complaint management and adverse event reporting.Take accountability for personal outcomes and their impact on team performance.Share experiences and insights to enhance processes and procedures.Act as a technical authority in complaint management and adverse event reporting, providing mentorship or training to new associates as needed.Regularly report on assignment statuses to your supervisor and ensure the completion of tasks involving complaint record corrections and CAPA or audit actions.Adhere to U.S. Food and Drug Administration (FDA) regulations, other applicable regulatory requirements, company policies, operational procedures, and assigned tasks.May undertake other duties related to complaint management and adverse event reporting as necessary.

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.

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 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.

Join SOCOTEC as the Director of Finance for Infrastructure, where you will play a pivotal role as a strategic finance leader overseeing financial operations for a dynamic $180M revenue division. This division spans a national footprint with a portfolio of recently acquired entities.In this influential position, you will report directly to the US CFO while also collaborating closely with operations leadership. You will lead an accounting team at the primary acquired entity and facilitate the seamless integration of new acquisitions into SOCOTEC's corporate structure. The ideal candidate will adeptly balance operational financial management with strategic leadership, and may require periodic travel to support national operations.Financial Leadership & OperationsDirect financial operations across multiple locations nationwide, ensuring precise and timely financial reporting for a $180M revenue division.Oversee daily accounting and finance functions, enhancing inherited processes and optimizing team structure for maximum efficiency.Maintain parallel financial reporting in legacy systems through 2026 while preparing for the Deltek Vantagepoint ERP migration in 2027.Collaborate with business and operations leaders to align financial strategies with divisional growth objectives.Ensure compliance with revenue recognition standards, billing accuracy, and robust financial controls.Enhance order-to-cash performance in partnership with corporate finance.Champion financial hygiene through accurate reconciliations, documentation, and audit preparedness across multiple systems.Execute additional tasks as assigned by your manager.Financial Analysis & PlanningTrack ongoing project financial performance, providing insightful cost control analysis and profitability insights.Generate actionable financial reports to support business decision-making at the divisional level.Lead divisional forecasting and budgeting initiatives, partnering with corporate finance on long-term strategic planning.Integration & Systems ManagementIn collaboration with the Director of Integrations, spearhead the financial integration of newly acquired entities into SOCOTEC's corporate framework, developing standardized integration processes to facilitate ongoing growth.Work with the corporate finance team on chart of accounts mapping, system configurations, and standardization of processes for ERP migration.Drive continuous improvements in financial processes, identifying opportunities to harmonize practices across acquired entities.

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.