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 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.
Provide quality oversight and direction to vendors to ensure cGMP compliance for clinical manufacturing.
Lead clinical lot disposition, batch record review, and QP certification for global trials.
Oversee GMP quality systems including deviations, investigations, and audits at contract manufacturing partners.
Pulmovant is a Roivant-backed clinical-stage biotechnology company developing innovative therapies for pulmonary diseases. It is a small, lean organization within the Roivant family, focusing on collaboration and innovation.
Manage supplier quality events, including nonconformances, root-cause analyses, CAPAs, and corrective actions.
Support supplier qualification, onboarding, audits, and performance monitoring through scorecards and metrics.
Collaborate cross-functionally with supply chain, regulatory, and operations teams to ensure GMP compliance.
Jobgether is an AI-powered job matching platform that connects candidates with hiring companies. It uses technology to review applications and share top-fitting shortlists with employers, focusing on objective and fair hiring.
Ensure the highest standards of patient safety and data integrity at clinical research sites through regular quality assurance reviews.
Execute the yearly corporate audit plan, tracking audits and preparing detailed outcome reports for management.
Provide ongoing guidance and best-practice recommendations to site personnel and clinical project teams.
Care Access is a clinical research company that brings world-class research and health services directly to communities. With hundreds of research locations and clinicians globally, they are dedicated to ensuring every person has the opportunity to understand their health and contribute to medical breakthroughs.
Lead quality assurance and audit activities across Bula’s regulatory database and production workflows to identify errors, trends, and compliance risks.
Analyze audit findings, document trends, and implement process improvements to strengthen consistency and accuracy.
Manage, coach, and develop the Legislative Information Specialist team while serving as a subject matter expert for FAQ and CPA processes.
Colibri Group is a leader in online professional education, serving more than one million learners each year. We are guided by values of Love, Joy, Boldness, Teamwork, and Curiosity, and we foster a collaborative and inclusive culture.
Provide strategic quality leadership for CMC activities across cell therapy programs.
Lead product quality strategy and lifecycle management with risk-based control strategies.
Oversee QC operations and external partner quality oversight.
BrainChild Bio is a clinical-stage biotechnology company developing CAR T cell therapies for central nervous system tumors. The company prioritizes pediatric brain tumors with a pipeline extending to adult indications, and every team member directly impacts bringing therapies to patients.
Serve as the primary Clinical QA point of contact for a Phase 3, global study.
Collaborate with cross-functional groups to support study start-up and execution.
Perform clinical site audits and support inspection readiness.
Priovant is a biopharmaceutical company committed to developing therapies for autoimmune diseases. They have a small, collaborative team with a hands-on culture.
Leads quality compliance, risk management, and vendor oversight programs to support late-stage development.
Manages inspection readiness, data integrity assessments, and regulatory authority interactions across GxP.
Provides senior-level quality judgment and drives risk-based decisions in a dynamic environment.
Braveheart Bio is a clinical-stage biopharmaceutical company developing therapies for hypertrophic cardiomyopathy and other cardiovascular diseases. It has a proven leadership team, strong financial foundation, and a high-value late-stage asset, offering an opportunity for mission-driven professionals.