Provide end-to-end Product Quality oversight for clinical and commercial programs, including drug substance, drug product, packaging, and labeling.
Lead resolution of deviations, OOS/OOT, change controls, CAPAs, and product quality complaints with risk-based decisions.
Represent Product Quality on CMC and external partner teams to support development, regulatory submissions, and commercialization.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into therapies for central nervous system disorders. The company values trust, ownership, curiosity, and results, fostering a culture of diversity and inclusion with a small but dedicated team.
Manage and oversee the GCP Quality Management System for global clinical operations, including decentralized trials.
Lead quality investigations, CAPAs, and audits to ensure compliance with regulatory standards.
Provide strategic quality advice and drive continuous improvement across the organization.
WEP Clinical partners with biopharmaceutical sponsors to bring treatments to patients through clinical trial delivery and home health services. With over 15 years of global experience, the company fosters a collaborative, innovative culture focused on improving patient outcomes.
Support GMP CMC operations including review of batch records, analytical data, and product release for clinical-use drug substances and products.
Manage quality oversight for GMP vendors, audits, and quality agreements, and act as a QA point of contact for internal and external partners.
Review and approve quality events such as OOS, deviations, CAPAs, and change controls to ensure regulatory compliance.
Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for patients with cancer, targeting the RAS/MAPK pathway. With a small, collaborative team and a casual, mission-driven culture, they are committed to erasing cancer.
Provide strategic quality oversight for global clinical operations, including decentralized clinical trials and patient-focused healthcare services.
Ensure compliance with global regulations, sponsor expectations, and established quality systems through risk management and continuous improvement.
Lead investigations, audits, and CAPA activities to support safe, efficient, and reliable clinical trial delivery.
The partner company is a mission-driven organization focused on improving access to healthcare solutions. They foster a supportive, inclusive, and collaborative work environment with a remote-first culture.
Own GTI's QA/QC policies, SOPs, and quality management system across a multi-state network, driving consistency and continuous improvement.
Direct company-wide sanitation and QC practices ensuring product purity, consistency, and compliance with regulatory standards.
Manage nonconformance records, CAPA processes, and complaint investigations to drive systemic improvements and regulatory compliance.
Green Thumb Industries is a multi-state cannabis operator involved in cultivation, manufacturing, and production of cannabis products. The company emphasizes a culture of quality, food-safety, and compliance excellence across its network.
Manage analytical development, QC, and stability activities at contract manufacturing sites.
Author and review CMC sections for US and ex-US regulatory filings.
Collaborate with Quality Assurance to close investigations and manage change controls.
BridgeBio is a biotech company that pioneered a 'moneyball for biotech' approach, pooling projects and early-stage research to reduce risk and develop medicines for rare diseases. They foster a culture of curiosity and experimentation with small teams of experts.
Own the systems that keep Daymark's clinical quality and safety program credible as it scales, including audits and incident investigations.
Partner with clinical leadership to embed quality standards into daily workflows, not layered on top.
Manage external audits and regulatory reviews, and provide clear-eyed analysis when issues arise.
Daymark Health is a value-based oncology company redefining the cancer care experience for patients, providers, and health plans. It is a growing company backed by leading venture capital firms, with a collaborative culture focused on transforming cancer care.
Provide strategic pharmaceutical development guidance as CMC lead to cross-functional project teams.
Develop robust formulations and manufacturing processes to support rapid registration of QED products.
Manage CRO relationships, drug forecasts, and regulatory submissions for clinical supply.
BridgeBio is a biotech company pioneering a 'moneyball for biotech' approach to reduce risk and accelerate development of life-changing medicines for rare diseases. They foster a culture of curiosity and experimentation, working alongside respected industry minds to reengineer the future of biopharma.
Lead CMC strategy and execution across clinical-stage therapeutic programs, ensuring regulatory alignment and manufacturing readiness.
Oversee external partnerships with CDMOs, consultants, and regulatory experts to deliver high-quality programs.
Manage CMC activities from due diligence through clinical development, balancing scientific rigor with operational speed.
The company is a partner organization in the biopharmaceutical industry, focusing on clinical-stage therapeutic programs. It operates in a high-growth, mission-driven environment with a culture of innovation and collaboration.
Create and maintain SOPs and guidance documents in compliance with ICH-GCP and federal and local regulations.
Conduct internal study reviews to ensure compliance and prepare official reports with findings and corrective actions.
Collaborate with operations teams to remediate noncompliance and participate in quality investigations and audits.
Headlands Research is dedicated to enhancing clinical trial delivery within communities. Founded in 2018, the company operates 20+ clinical trial sites across the US and Canada and is rapidly expanding.