Implement and maintain best-in-class quality systems in compliance with FDA, ICH, 21 CFR Part 11, and ISO 9001.
Foster a culture of quality excellence and continuous improvement across the organization.
Manage day-to-day activities of a lean, high-performing quality team and optimize workflows.
N-Power Medicine aims to reinvent drug development by transforming clinical trials through better integration with clinical practice. They are building a multi-disciplinary team with diverse expertise in healthcare, engineering, technology, and regulatory, sharing a core value of empowering community through generosity, curiosity, and humility.
Own Cadence's QMS strategy and regulatory operating model for AI-enabled healthcare software, SaMD, and technology-enabled care workflows.
Lead quality system governance across design controls, risk management, CAPA, change control, document control, training, and audit readiness.
Partner with Product, Engineering, and Clinical teams to assess regulatory pathway, device classification, and QMS requirements for new software capabilities.
Cadence is a clinical AI company that delivers continuous, proactive care for older adults with chronic conditions. They operate as a full clinical care delivery organization with clinicians working alongside health system partners, helping Medicare save $2M a week.
Build, maintain, and continuously improve the company's Quality Management System (QMS) and oversee GxP CSV requirements.
Own the design and administration of the electronic QMS, including validation, document control, and compliance activities.
Lead internal audit and inspection-readiness programs, supporting regulatory inspections and promoting a culture of quality.
Loyal is a clinical-stage veterinary medicine company developing longevity drugs for dogs, targeting the underlying drivers of aging to delay disease and preserve quality of life. As a well-funded startup with teams of scientists, veterinarians, engineers, and creatives, it is pioneering the first FDA-approved lifespan extension medicine.
Serve as a subject matter expert for site management and monitoring strategies across complex clinical studies.
Collaborate with clinical teams, investigators, and stakeholders to ensure compliance, data quality, and trial success.
Mentor CRA staff, resolve escalated issues, and support site qualification, initiation, monitoring, and close-out visits.
Jobgether is a platform that uses AI-powered matching to connect candidates with job opportunities. They operate as a global healthcare and technology environment, offering professional growth and innovative solutions.
Provide QA oversight for CMC drug product and device operations, ensuring compliance with global GMP regulations.
Approve protocols, batch records, and disposition batches for clinical trials in partnership with external vendors.
Support health authority inspections and regulatory filings, driving continuous improvement in sterile manufacturing.
Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases through innovative anti-FcRn therapies. As a growing biopharmaceutical firm, the company fosters a dynamic, entrepreneurial culture with a focus on compliance and patient safety.
Serves as clinical trial lead, overseeing study planning, conduct, and oversight per protocol and regulations.
Develops study documents, manages site feasibility, and drives recruitment strategies.
Leads internal clinical team meetings and ensures quality deliverables through metric reporting.
Precision Medicine Group is a life sciences company that supports clinical research and development. The company is large enough to offer a range of benefits and emphasizes a collaborative, ethical culture focused on quality and compliance.