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.
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.
Develop and lead the enterprise compliance program strategy and roadmap.
Serve as program manager for compliance buildout and commercialization-readiness initiatives.
Provide practical guidance on healthcare compliance risks related to commercialization.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for autoimmune diseases. The company is guided by core values and committed to transforming treatment for autoimmune disease, fostering a culture of ethics and integrity.
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.
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.
Lead global Pharmacovigilance Operations, Quality & Compliance strategy to ensure scalable, inspection-ready systems.
Oversee case processing, vendor governance, PSMF, quality systems, audits, and regulatory inspections.
Build and mentor a global team, collaborating cross-functionally to support portfolio growth and commercialization.
Ultragenyx is a biopharmaceutical company focused on developing life-changing treatments for rare diseases. They foster a supportive and inclusive culture of learning and growth, aiming to be an organization where employees can thrive personally and professionally.
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.
Lead pharmacovigilance strategy and operations across the portfolio, ensuring regulatory compliance and safety oversight.
Oversee outsourced PV vendors, build quality systems, and manage safety data exchange agreements.
Partner cross-functionally with Clinical Development, Regulatory, and Quality to advance pipeline from early to late-stage development.
Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies for autoimmune diseases. It is a lean organization with a build-oriented culture, advancing a pipeline from Phase 1 to Phase 3.
Influence entire compliance programs by translating strategic priorities into clear visions and executable programs with measurable outcomes.
Establish portfolio management frameworks and serve as the primary point of contact for executive leadership on mission-critical compliance programs.
Drive cross-functional delivery of regulatory compliance programs and improve audit processes for R&D.
Twilio is a leading communications platform that delivers innovative solutions to hundreds of thousands of businesses and empowers millions of developers worldwide. They are a remote-first company with a strong culture of connection and global inclusion.
Identify and assess risks in clinical trial data to ensure quality and integrity.
Develop and implement risk mitigation strategies for data governance and compliance.
Collaborate with cross-functional teams to enhance data management practices and support informed decision-making.
The company is a clinical research organization specializing in data risk analysis for clinical trials. It operates with a global team focused on improving data quality and integrity in a collaborative remote environment.
Provide practical advice and guidance across quality assurance, compliance, governance, assessment, moderation, and risk.
Oversee assessment and moderation practices, identifying gaps or risks, and supporting improvement activities.
Contribute to wider quality and risk initiatives and projects to strengthen organisational performance.
Yoobee Colleges is New Zealand's largest Category Two Private Training Establishment, educating 7,000 learners through a collective of industry-leading tertiary education providers in creative, technology, tourism, beauty, and healthcare fields. We foster a diverse and inclusive culture, supporting professional growth with a highly collaborative and supportive 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.
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.
Lead and execute risk-based internal audits across pharmaceutical and medical device operations.
Serve as Lead Auditor for complex, multi-site audits, driving continuous improvement of the QMS.
Support inspection readiness and regulatory authority/notified body audits.
Agilent Technologies is a global leader in laboratory and clinical technologies, providing instruments, software, and consumables for life science research and diagnostics. With 18,000 employees, we foster an inclusive, dynamic culture built on trust and integrity.
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.
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.
Implement and operate Mercury’s first prudential regulatory compliance program for banking, focusing on Regulations W and O.
Interface directly with senior management to advise on permissibility and advisability of proposed transactions.
Educate and grow Mercury’s compliance culture by providing training and guidance to bank staff on prudential regulatory requirements.
Mercury is a fintech company building a chartered bank to provide banking services for startups. It is a growing company with a culture that values diversity and belonging, and is an Equal Employment Opportunity employer.
Lead and scale the Computer System Validation capability across IT, defining validation strategy, operating model, and risk-based approach while building the CSV team.
Author, review, and execute validation lifecycle deliverables including validation plans, requirements, risk assessments, and test protocols.
Collaborate with Quality, IT, business owners, and vendors to translate compliance needs into practical, scalable validation strategies.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders. It is a lean and growing organization guided by core values of Trust, Ownership, Curiosity, and Results, with a commitment to diversity, equity, and inclusion.
Oversee day-to-day operations of clinical trials, ensuring compliance with GCP, FDA, and ICH guidelines while managing CROs and vendors.
Serve as primary point of contact for CROs and trial vendors, tracking performance metrics, budgets, and timelines to ensure project success.
Collaborate with cross-functional teams to prioritize data integrity, participant safety, and quality control, with travel required up to 30%.
Peptilogics is a surgical therapeutics company dedicated to curing and preventing medical device-related infections. They are a clinical-stage biotech with a small, agile team and a culture of proactive, independent thinking.