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.
Lead the execution and continuous improvement of quality management systems to ensure compliance with FDA, ICH, GCP, and ISO 9001 standards.
Manage electronic Quality Management System (eQMS) including document control, CAPA, risk management, and audit processes.
Provide quality oversight for clinical trial activities and software development lifecycle, collaborating with cross-functional teams.
The partner company is a fast-growing healthcare and life sciences organization focused on improving clinical research. It values collaboration, curiosity, and continuous improvement, and supports teams through scalable systems and risk management.
Maintain and improve the Quality Management System (QMS) and support compliance with CMMI, CMMC, and ISO standards.
Support government contract compliance, coordinate audits, and manage documentation for contracts and IDIQ vehicles.
Develop dashboards and reports for compliance, audits, and PMO maturity metrics.
True Zero Technologies is a veteran-owned small business that focuses on enabling people and technology to drive quality outcomes. The company has been recognized as a Best Places to Work honoree and has appeared on the Inc. 5000 list of fastest-growing companies, reflecting its people-first culture and commitment to excellence.
Lead execution of RBQM strategy across complex clinical trials, including risk assessments and monitoring plans.
Partner with cross-functional teams and CROs to identify, track, and mitigate risks proactively.
Ensure compliance with global regulations, drive process improvements, and report KRIs to leadership.
Deciphera is a biopharmaceutical company focused on developing kinase inhibitor therapies for cancer. The company offers a competitive compensation package and promotes a culture of personal and professional growth.
Act as subject matter expert for the Document Control process area, owning lifecycle management of quality processes and records.
Serve as System Administrator of Veeva’s internal electronic Document Management System (eDMS), responsible for configuration and continuous improvement.
Provide quality oversight on regulated activities, such as process definition, validation testing, and product releases for in-scope systems.
Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $3B in revenue in our last fiscal year with extensive growth potential ahead.
Develop, mentor, coach and manage CTMs to progress their skillset per quality standards.
Collaborate with management to enhance CTM expectations and procedures for quality and efficiency.
Ensure CTMs have proper resources and training to deliver high-quality study conduct.
Precision for Medicine is a clinical research organization (CRO) that provides clinical trial management services. The company employs a large team of clinical research professionals and emphasizes quality and collaboration.