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 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.
Lead and develop a world-class Service & Repair Quality organization across multiple international sites, driving continuous improvement and regulatory compliance.
Apply global regulatory requirements to Service & Repair processes, including FDA, GMP, CAPA, ISO 13485, and lead quality support during regulatory inspections.
Develop statistically sound sampling plans, use data analysis to identify trends, and build strong partnerships with site leadership and stakeholders.
This is a senior quality leadership opportunity within a global medical technology environment focused on delivering safe, reliable, and innovative healthcare solutions. The company is a partner of Jobgether, with operations across the US, Germany, and Japan, and emphasizes a collaborative, ethical, and inclusive culture.
Provides regulatory CMC support for drug-device combination products.
Reviews submission documentation and contributes to global regulatory strategies.
Collaborates with cross-functional teams including device development, quality, and clinical.
Vertex Pharmaceuticals is a global biotechnology company dedicated to developing transformative medicines for serious diseases. With thousands of employees, it fosters a collaborative and innovative culture focused on patient impact.
Serve as Global Process Owner for CAPA subsystem, ensuring compliance with FDA, ISO, and EU MDR requirements.
Lead complex investigations using root cause analysis tools and mentor cross-functional teams on best practices.
Monitor CAPA performance through KPIs, facilitate CAPA Review Board, and drive systemic improvements.
Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease using AI-driven, non-invasive cardiac tests. The company is publicly traded, has been used for over 500,000 patients worldwide, and is supported by international medical societies.
Review CMC sections of regulatory submissions for drug-device combination products, ensuring accuracy and alignment with global requirements.
Contribute to global regulatory CMC strategies and provide guidance to cross-functional stakeholders.
Collaborate with device development, quality, clinical, human factors, and other teams to support product compliance and change controls.
The company specializes in drug-device combination products and operates in a cross-functional, science-driven environment. The culture emphasizes collaboration across regulatory, device development, quality, clinical, and human factors teams.
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.
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.
Lead quality assurance activities to support patient safety and pharmacovigilance compliance across global operations.
Plan, conduct, and manage pharmacovigilance audits, CAPA programs, and regulatory inspection readiness activities.
Collaborate with cross-functional teams including clinical development, regulatory affairs, and medical affairs to maintain robust quality systems.
This company is a science-driven healthcare organization focused on pharmacovigilance and patient safety. They operate in a collaborative, global environment committed to operational excellence and meaningful healthcare impact.
Lead global pharmacovigilance audits, regulatory inspections, and readiness planning.
Oversee issue management, deviations, root-cause analysis, and CAPA activities.
Develop and manage the global pharmacovigilance training program and procedural documentation.
Our partner is a fast-growing biopharmaceutical company focused on improving outcomes for patients with severe autoimmune diseases. It offers a collaborative environment with opportunities for professional growth and leadership development.
Provide regulatory guidance throughout the clinical development lifecycle and prepare quality regulatory submissions.
Compile, coordinate, and review applications to regulatory authorities, including CTA/IND and amendments.
Represent Global Regulatory Affairs at project team and business development meetings, overseeing Regulatory Affairs Specialists.
Precision Medicine Group is a life sciences company providing clinical research, regulatory, and commercial services to biopharmaceutical clients. It fosters a collaborative, quality-focused culture and is an Equal Opportunity Employer.
Support and contribute to global regulatory strategies to expedite development and mitigate risks.
Plan, prepare, and coordinate regulatory documents for submissions to global health authorities (INDs, BLAs, MAAs, etc.).
Collaborate with cross-functional teams and support interactions with FDA and other Health Authorities.
Immunovant, Inc. is a clinical-stage immunology company developing targeted therapies for autoimmune diseases. As a rapid-growth biotech startup, it fosters a dynamic, fast-paced, and entrepreneurial environment.