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.
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.
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.
Mentor and support the quality assurance team to enhance skills and drive motivation.
Evaluate calls to ensure adherence to scripts, SOPs, and compliance regulations.
Generate reports on call quality scores and provide data-driven insights to management.
Natera is a global leader in cell-free DNA testing, dedicated to oncology, women's health, and organ health. The team consists of highly dedicated professionals from world-class institutions who care deeply about their work and each other.
Serve as an agency expert on our quality assurance program
Monitor quality reporting to identify trends and problems
Collaborate with the Director of Quality & Compliance on strategies to improve focus areas
Trellis is rewriting the insurance experience by building a tech-powered insurance agency. We are a profitable, fast-growing Series A startup backed by top venture firms, with a remote-first culture that values speed, experimentation, and intentional building.
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.
Lead internal audits, gap assessments, and action item closure for periodic QMS reviews
Manage and maintain design and development files for FDA regulated products
Build and refine quality systems and SOPs in line with cGxP, ISO 13485, and other applicable standards
UpDoc builds the first clinically validated, physician-supervised AI agents that manage chronic diseases. Founded by Stanford physicians, it is an early-stage startup focused on bringing its AI-powered platform to patients and providers.
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.
Independently reviews sales transactions and customer files to ensure compliance with quality, regulatory, and risk standards.
Provides evidence-based feedback and coaching to frontline teams to improve performance and understanding of quality expectations.
Collaborates with operational leaders, risk partners, and compliance teams to strengthen quality awareness and risk management practices.
Our partner is a company looking to strengthen operational excellence by reviewing sales transactions and customer files for compliance with quality, regulatory, and risk standards. The organization fosters a culture of accountability, transparency, and continuous improvement, offering a supportive environment focused on professional growth and collaboration.
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.
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 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 independent support for quality, safety, and compliance initiatives across client assignments and internal programs.
Develop, monitor, and improve program performance metrics, objectives, and targets to enhance operational outcomes.
Plan, lead, and support internal and client audits, assessments, and compliance reviews to evaluate program performance.
Our partner supports critical government missions by strengthening quality, safety, and compliance programs within highly regulated environments. They are a federal contractor seeking experienced professionals to contribute to meaningful work with a culture of safety, accountability, 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.
Manage and coordinate a formal quality improvement program across a large network of crisis centers to achieve quality improvement goals.
Oversee internal QI activities, ensure adherence to funder and agency goals, and prepare reports for external stakeholders.
Collaborate with other departments to develop proactive QI activities and monitor performance to ensure compliance with operational and clinical KPIs.
Vibrant Emotional Health provides high-quality services and support for emotional wellness through technology-enabled services, community programs, and advocacy. For over 50 years, they have been at the forefront of promoting emotional well-being, with a focus on saving lives and supporting everyone in need.
Drive cross-functional collaboration and track progress using project management tools to ensure on-time delivery of objectives.
Conduct audits of call and email communications to assess quality and accuracy, compiling feedback summaries for management.
Support patient-focused teams with quality improvement initiatives and maintain documentation such as SOPs and protocols.
Natera is a global leader in cell-free DNA testing for oncology, women's health, and organ health. The team consists of highly dedicated statisticians, geneticists, doctors, and other professionals from world-class institutions, fostering a culture of hard work and growth.
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.
Lead end-to-end GCP auditing processes, including scheduling, conducting, reporting, and follow-up for sites, vendors, and internal processes globally
Apply deep knowledge of FDA, EU, and ICH regulations to independently resolve compliance issues and represent GDQA on cross-functional teams
Develop risk-based audit strategies, mentor new staff, and support regulatory inspections with 6+ years of experience including 4+ years direct GCP auditing
Regeneron is a leading biotechnology company that invents life-changing medicines for people with serious diseases. Founded and led by physician-scientists for over 30 years, we have developed nine FDA-approved treatments and numerous candidates, fostering a culture of innovation recognized as a Great Place to Work.
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.
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 clinical quality, quality improvement, and risk adjustment programs in a managed care environment.
Analyze performance data to identify trends, gaps, and opportunities for improved care and cost reduction.
Provide people leadership, coaching, and development to clinical and quality team members.
Our partner is a healthcare organization focused on improving access, quality, and outcomes. They operate in a managed care environment with a collaborative, purpose-driven culture.