Administer and support GxP and Quality systems (eQMS, CMMS, validation platforms) to ensure compliance and reliability.
Manage user access, SSO/SCIM, system configurations, and validation/change control activities.
Investigate incidents, support audits, and collaborate with IT, Quality, and vendors for inspection readiness.
This company provides technology-enabled services in regulated industries, supporting GxP and quality systems for clients. It offers a collaborative and inclusive environment that values diversity, integrity, and professional growth.
Review and approve validation of software and AI products to ensure full compliance with regulatory requirements and company policies.
Prepare for and support external regulatory audits; lead internal or vendor audits related to maintaining GxP and regulatory compliance.
Develop and maintain digital/software components of quality management systems, including AI quality management systems.
Care Access brings world-class research and health services directly to communities that often face barriers to care. With hundreds of research locations, mobile clinics, and clinicians across the globe, they are reimagining how clinical research and health services reach the world.
Support end-to-end eQMS implementations for life sciences organizations, coordinating timelines, deliverables, and risks.
Participate in system configuration, data migration, validation documentation, and UAT to ensure regulatory and data integrity compliance.
Collaborate with Quality, IT, Validation, vendors, and client teams across all implementation phases, including go-live and post-implementation support.
The hiring partner company supports end-to-end Quality Management System implementations for life sciences clients. They offer a remote contract-to-hire opportunity with potential for long-term growth.
Lead the development and execution of Computer System Validation (CSV) and Computer Software Assurance (CSA) strategies, plans, and protocols.
Ensure GxP-regulated systems comply with FDA, ISO, and other global regulatory requirements through risk-based validation and documentation.
Collaborate with IT, Quality, Engineering, and Manufacturing teams to support compliant system implementations and lifecycle management.
The company is a technology-driven organization in the healthcare and life sciences sector, focused on ensuring the safety, quality, and reliability of computerized systems used in regulated environments. It fosters a collaborative culture that values continuous improvement, professional growth, and cross-functional teamwork.
Lead GCP quality for clinical studies as the primary Quality point of contact from start-up through close-out.
Build the GCP quality framework, authoring SOPs, quality plans, and risk management aligned with ICH E6(R3).
Qualify and audit CROs, clinical sites, and vendors, and partner on inspection readiness.
Osanni Bio is a development-stage therapeutics platform headquartered in San Francisco, California, advancing programs in ophthalmology, cardiology, and beyond. They are a creative, agile team of innovators guided by core values of integrity, impact, agility, and collaboration.
Lead and supervise a team of regulatory specialists managing labeling approvals, drug listings, and medical device submissions.
Oversee FDA compliance, quality investigations, and health hazard evaluations to ensure product integrity.
Collaborate cross-functionally with Quality Assurance, Legal, and external partners to resolve complex regulatory challenges.
The partner company is a pharmaceutical and medical device organization focused on ensuring regulatory compliance and product quality. The company fosters a collaborative and inclusive work environment, emphasizing continuous improvement and professional development.
Serves as the primary Quality administrator for Veeva QualityOne and supports audits, training, and audit readiness.
Grüns makes comprehensive nutrition gummies from 60 whole-food ingredients, designed to be simple and convenient. The company operates as a fully remote, high-trust team that values ownership, high standards, and wellness.
Administer the lifecycle of GxP and Quality governed systems including eQMS, CMMS, and Digital Validation applications.
Perform user account administration, role-based access control, and periodic access reviews.
Support Computer Software Assurance activities, change control, and CAPA investigations.
CAI is a professional services company established in 1996 that provides accelerated operational readiness and high-standard performance for mission-critical industries. The company has grown to nearly 800 employees worldwide and fosters a culture of integrity, service, and excellence.
Own the full post-sale journey for Kivo's customers, driving outcomes, retention, and expansion.
Lead end-to-end implementations of the Kivo platform, from solution design and configuration to validation and go-live support.
Serve as strategic partner and primary account point of contact, managing account health and partnering with Sales on expansion opportunities.
Kivo is a life-sciences SaaS platform specializing in quality management for pharmaceutical, biotech, and medtech organizations. It is a hyper-growth, fast-paced company focused on delivering customer success in regulated environments.
Own and continuously improve the Quality Management System for simulation products, programs, and services.
Serve as the primary quality liaison for customers, suppliers, and subcontractors, ensuring requirements flow down and are met.
Drive risk-based audits, CAPA activities, and root-cause analysis to improve quality performance and compliance.
Aechelon Technology, a Shield AI company, produces 3D simulator content including geospecific visual/sensor databases and realistic 3D models for pilot training. The company seeks passionate people committed to real-time computer graphics and the mission of improving pilot safety.
Oversee GCP compliance, manage deviations and CAPAs, and conduct quality and TMF reviews.
Maintain inspection readiness and support CRO oversight per ICH E6(R3).
Collaborate with Data and Clinical teams to embed compliance into workflows and train teams.
Resilience Care is a French medtech founded in 2021, offering AI remote monitoring for oncology, gastroenterology, and psychiatry. It serves 35,000 patients across 200+ facilities with an agile, collaborative culture.
Ensures supplier compliance with ISO 13485, MDSAP, and EU MDR regulations.
Conducts supplier audits as Lead Auditor and owns supplier quality processes, SCARs, and CAPAs.
Partners with cross-functional teams to improve supplier controls and supports regulatory inspections.
Intuitive Surgical is a global leader in minimally invasive care, best known for its da Vinci surgical systems. The company values quality, compliance, and innovation, with a cross-functional and engineering-driven culture.
Lead a high-performing team of Account Partners selling global enterprise eQMS solutions to large manufacturing organizations.
Drive enterprise sales execution, coach complex deal strategy, and build long-term strategic relationships across Quality, IT, Operations, and Procurement leadership.
Meet/exceed pipeline generation and new revenue targets while ensuring accurate forecasting and expansion of multi-year agreements.
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 and became a public benefit corporation in 2021, with a culture focused on customer success, employee success, and speed.