Lead GCP quality for clinical studies as the primary Quality point of contact from start-up through close-out.
Build the GCP quality framework, authoring SOPs, quality plans, and risk management aligned with ICH E6(R3).
Qualify and audit CROs, clinical sites, and vendors, and partner on inspection readiness.
Osanni Bio is a development-stage therapeutics platform headquartered in San Francisco, California, advancing programs in ophthalmology, cardiology, and beyond. They are a creative, agile team of innovators guided by core values of integrity, impact, agility, and collaboration.
Develop and execute the Quality practice's long-term growth strategy, expanding service offerings for biotech and pharma clients.
Build and scale a high-performing Quality organization with strong P&L ownership and delivery excellence.
Serve as a trusted advisor to executive leadership teams, providing strategic GxP quality leadership and oversight.
Syner-G accelerates breakthrough science and delivery of life-enhancing therapies through expertise, insight, consulting and management skills. The company was recently honored with BioSpace's "Best Places to Work" 2026 award for the third consecutive year, fostering a culture of growth, learning, and reward.
Lead Kailera's end-to-end clinical and commercial supply chain, ensuring reliable delivery of investigational and commercial drug products.
Build and develop a high-performing global supply chain team, establishing governance, partnerships, and performance metrics.
Set global supply strategy and oversee logistics, compliance, systems, and budget to scale with company growth.
Kailera Therapeutics is a biopharmaceutical company developing novel therapies for obesity and related conditions. The company fosters an entrepreneurial, team-oriented culture focused on collaboration, integrity, and excellence.
Lead the development and implementation of an integrated Quality Management System (QMS) covering GxP activities across GMP and GCP functions.
Oversee key quality processes including deviations, CAPA, change control, document control, training, risk management, and computerized system validation.
Drive regulatory inspection readiness, including Pre-Approval Inspections, and establish quality metrics, dashboards, and continuous improvement initiatives.
This pharmaceutical and biotechnology company is preparing for commercialization of an innovative treatment. It is a growing organization focused on building scalable quality systems, fostering a culture of quality ownership, continuous improvement, and regulatory compliance.
Ensures supplier compliance with ISO 13485, MDSAP, and EU MDR regulations.
Conducts supplier audits as Lead Auditor and owns supplier quality processes, SCARs, and CAPAs.
Partners with cross-functional teams to improve supplier controls and supports regulatory inspections.
Intuitive Surgical is a global leader in minimally invasive care, best known for its da Vinci surgical systems. The company values quality, compliance, and innovation, with a cross-functional and engineering-driven culture.
Manage global regulatory affairs activities for Spyre's IBD program, developing strategies to enable clinical trials and marketing applications.
Lead preparation and submission of regulatory applications to FDA, EMA, and other global health authorities, ensuring timely approvals.
Collaborate cross-functionally with research, clinical, and technical teams to integrate regulatory considerations and mitigate risks.
Spyre Therapeutics is a clinical-stage biotechnology company developing next-generation immunology therapies. It is a young company with a fast-paced, dynamic culture focused on advancing meaningful medicines for patients.
Lead a centralized team of Data Coordinators to ensure accurate, timely, and complete clinical research data.
Manage workload, quality, and compliance for data activities across the Care Access site network.
Partner with clinical operations, sponsors, and CROs to resolve data issues and improve processes.
Care Access brings clinical research and health services directly to communities through hundreds of research locations and mobile clinics. They are dedicated to making health care more accessible and put people at the heart of medical progress.
Lead ISO 13485 lead audits of global 3PL providers, distribution hubs, and service suppliers.
Develop and maintain global 3PL quality programs, quality agreements, and compliance frameworks.
Drive CAPA/SCAR processes, quality metrics, and serve as SME during regulatory inspections.
Intuitive is a global leader in robotic-assisted surgery and minimally invasive care, developing technologies such as the da Vinci surgical system. The company brings together engineers, clinicians, and innovators focused on making surgery smarter, safer, and more human.
Review and approve validation of software and AI products to ensure full compliance with regulatory requirements and company policies.
Prepare for and support external regulatory audits; lead internal or vendor audits related to maintaining GxP and regulatory compliance.
Develop and maintain digital/software components of quality management systems, including AI quality management systems.
Care Access brings world-class research and health services directly to communities that often face barriers to care. With hundreds of research locations, mobile clinics, and clinicians across the globe, they are reimagining how clinical research and health services reach the world.
Serve as primary medical and scientific expert for clinical trial protocols and Expanded Access Programs.
Monitor trials to ensure participant safety, data accuracy, and protocol compliance.
Lead protocol development, investigator training, and cross-functional collaboration.
WEP Clinical partners with biopharmaceutical sponsors to deliver clinical trials, expanded access programs, and market access solutions. With 15+ years of experience across 150+ countries, they offer operational scale and a personalised culture.
Ensure product complaint investigations and procedures comply with FDA QSR, ISO, and Medical Device Directives for Vigilance.
Perform FTIR analysis and program mechanical lab equipment such as Chatillon to support material identification and complaint investigations.
Provide audit support and enforce compliance with equipment maintenance, hazmat, biohazard, and disposal management protocols.
Embecta is a global medical device company with a 100-year legacy in insulin delivery and diabetes care. We are expanding our portfolio of solutions to serve more patients, healthcare providers, and communities worldwide.
Prepare and submit clinical trial applications to Competent Authorities and Ethics Committees, ensuring compliance with local and international regulations.
Manage essential documents, informed consent forms, and site activation readiness, mitigating risks to timelines.
Act as subject matter expert and mentor for site start-up activities, maintaining regulatory intelligence and audit readiness.
Precision Medicine Group provides clinical trial services, including regulatory and site start-up support. The company is expanding across Latin America and values expertise, collaboration, and compliance.
Provide strategic and operational leadership across multiple clinical programs, translating development strategy into strong execution.
Oversee clinical trial planning, budgets, CRO/vendor relationships, and cross-functional collaboration to ensure quality and accountability.
Lead and develop a small Clinical Operations team while remaining hands-on in a fast-paced biotech environment.
Deciphera, a member of Ono Pharmaceutical Co., Ltd., is a biopharmaceutical company focused on discovering, developing, and commercializing new medicines for cancer, neurologic, and autoimmune diseases. The company fosters an inclusive culture valuing curiosity, creativity, and shared accountability, empowering employees to drive breakthroughs.
Lead Clinical Trial Supply activities across the study lifecycle ensuring compliant supply.
Manage IMP forecasting, packaging, labeling, and distribution with internal teams and vendors.
Oversee vendor management, contract negotiations, and documentation for trials.
Immunic Therapeutics is a biotechnology company focused on clinical research and development. The company fosters a diverse and inclusive workplace culture with an emphasis on equity and collaboration.