Develop and report key quality metrics across all clinical programs and trials.
Ensure compliance with GCP, ICH-GCP, FDA, EMA, PMDA, and applicable regulations.
Drive inspection readiness at local and global levels.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. Their core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of their business.
Develop standard operating procedures, work instructions, forms, and templates to ensure a fit-for-purpose clinical auditing and inspection management program.
Develop dynamic, risk-based audit strategy and plan for critical sponsor processes and clinical trials.
Plan, lead, conduct, document, report, and follow-up of clinical quality audits according to regional compliance regulations, guidance, contracts, and quality agreements.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. Their core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of their business.
Lead all quality assurance and control initiatives for our brand implementation business, focusing on exterior signage and interior branding. Drive continuous improvement across design, fabrication, and field operations, ensuring the highest standards of craftsmanship and compliance. Champion a culture of quality excellence and customer satisfaction throughout the organization.
Stratus is the market leader in brand implementation and maintenance, transforming how national brands connect with their customers.
Oversee clinical quality assurance, develop training programs, and ensure regulatory compliance.
Design, implement, and oversee clinical quality assurance programs for in-home care delivery.
Design and implement onboarding and continuing education programs for clinical team members.
Sprinter Health is an innovative healthcare startup dedicated to providing high-quality, in-home and virtual care across the country. They employ a multidisciplinary team of clinicians, technologists and operators backed by investors including a16z, General Catalyst, GV, and Accel.
Oversee the drug substance, drug product, reference standard, and packaging/labeling/serialization contract service providers for clinical-phase and commercial production activities.
Review and approve key strategic product / process documents (i.e. specifications, batch records, tech transfer/validation protocols, etc.).
Lead, review and approve change controls, deviations, temperature excursions, investigations, OOX, CAPA, and Product Quality Complaints.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. Their core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of their business and are exemplified by each and every one of their team members.
Owns the CAPA system and leads as the Subject Matter Expert (SME).
Leads cross-functional teams in facilitating CAPA Boards and Root Cause Analysis teams.
Monitors KPIs and drives systemic improvements to ensure products meet the highest standards.
Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, the #1 cause of death worldwide, using cutting-edge technology.
Assist with daily site activities, acting as the primary point of contact for the site.
Assist with training and mentoring research staff, upholding professional development goals.
Promote strict adherence to ICH-GCP, FDA, and local regulations, maintaining audit readiness across all studies.
Care Access aims to improve the future of health for everyone. They operate globally with research locations, mobile clinics, and clinicians, bringing health services to communities, and are dedicated to ensuring every person can understand their health, access care, and contribute to medical progress.
Drive execution of NPI strategy to develop scalable, high-yield processes.
Optimize inspection strategies through technology, automation, and supplier certification.
Coach and develop a team of quality engineers to meet performance metrics.
Stryker is a leading medical technology company committed to improving healthcare. They offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine. They are proud to be named one of the World’s Best Workplaces!
The Director, MSSP Quality will lead cross-functional operational initiatives across Provider Networks and Product to ensure comprehensive data integrity and optimal performance in Quality reporting.
The Director will be responsible for managing and resolving field queries, preparing comprehensive reporting for executive and practice leadership, and formulating strategic initiatives for MSSP Quality programs across the organization.
The role requires strong leadership capabilities, analytical experience, and the ability to collaborate effectively with cross-functional teams while translating complex quality data into actionable insights that drive organizational excellence in MSSP Quality performance.
Aledade empowers independent primary care practices to deliver better care and thrive in value-based care. Founded in 2014, they are the largest network of independent primary care in the country with a collaborative, inclusive, and remote-first culture.
Set program quality goals, roadmap, and operating rhythms.
Manage a team of Analysts and Coordinators; hire, coach, and run performance cycles.
Co-own client governance with Ops; align on scope, priorities, and changes.
Welo Data provides high-quality, ethically sourced, relevant, diverse, and scalable datasets to technology companies to supercharge their AI models. As a Welocalize brand, they bring together a global community of over 500,000 AI training and domain experts.
Support operational planning, start-up, execution, and close-out activities for Phase 3 clinical studies in HCM.
Oversee CROs, vendors, clinical sites, and external partners to ensure delivery of high-quality data, adherence to timelines, and compliance with GCP and regulatory requirements.
Lead selection, onboarding, and oversight of CROs, central labs, imaging vendors, and specialty service providers.
Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease.