Provide quality oversight of sterile drug product and finished drug product manufacturing, labeling, packaging, and distribution operations.
Review and approve batch production records, process validation documents, and quality system records such as deviations and change controls.
Support regulatory agency inspections and author NDA CMC sections to ensure compliance with GMP and GDP standards.
Amylyx Pharmaceuticals is a clinical-stage company focused on treating diseases with high unmet needs, such as post-bariatric hypoglycemia, Wolfram syndrome, and ALS. The company has an experienced team driven by core values of audacity, curiosity, authenticity, engagement, and accountability, fostering a culture of caring.
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.
Lead project initiation, planning, and execution for API and drug product development projects.
Serve as liaison between clients, technical teams, and business development to ensure project success.
Monitor project progress, report to stakeholders, and implement corrective measures using risk assessment tools.
WuXi, through its STA division, provides API and drug product development and manufacturing services. The company is a leading global contract research and manufacturing organization with a focus on small molecule development.
Own and evolve the strategic roadmap for PHIL’s external integrations, linking business strategy to technical requirements.
Solve complex problems by driving improvements in quality and speed through optimized processing and platform capabilities.
Lead cross-functional partnerships with senior stakeholders across Product, Engineering, Operations, and Commercial teams.
PHIL is a health-tech startup building a B2B2C platform that connects patients, prescribers, pharmacies, and manufacturers to streamline prescription management. The team is a group of like-minded individuals from varying backgrounds, passionate about creating an innovative healthcare platform focused on patient experience.
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.
Lead definition and implementation of engineering processes for compliance and certification.
Translate complex standards into actionable engineering practices.
Collaborate with teams to embed quality and compliance into development lifecycle.
Canonical develops Ubuntu and makes it suitable for mission-critical environments in regulated industries. The company fosters an inclusive, global, remote-first engineering culture focused on excellence and innovation.
Lead a multi-disciplinary engineering team delivering design changes for nuclear infrastructure.
Ensure compliance with UK nuclear regulations and safety standards, including ONR and ALARP principles.
Manage engineering change, commissioning, and technical governance within a Design Authority environment.
Assystem is an international company accelerating the energy transition worldwide. With over 6,500 employees in 12 countries and more than 55 years of experience, the Group is ranked second globally in nuclear engineering.
Provide domain expertise to design and build AI tasks that amplify productivity.
Share knowledge about day-in-the-life workflows for regulatory submissions.
Generate or review reference ground-truth artifacts for evaluation.
Edison Scientific builds and deploys AI scientist agents to accelerate science and the development of new medicines. The team is ambitious and run by scientists and engineers from leading institutions across biology, physics, chemistry, and AI.
Provide remote technical, applications, and system admin support for medical imaging systems, managing audits, operational applications, and billable projects.
Work with Sales and internal teams to pass profitable opportunities, assess hardware/software/network issues, and provide troubleshooting and guidance to Customer Support Engineers.
Maintain expert knowledge of medical imaging products, document solutions, and comply with regulatory and quality requirements.
FUJIFILM Healthcare Americas Corporation provides cutting-edge healthcare solutions including diagnostic imaging, endoscopic and surgical imaging, and in-vitro diagnostics. With over 70,000 employees globally and a dynamic, flexible environment, they are guided by the purpose of "giving our world more smiles."
Lead product development, formulation, and process optimization for innovation, renovation, and productivity initiatives.
Manage scale-up, technology transfer, and commercialization with internal and external partners.
Troubleshoot formulation and quality issues, applying structured problem-solving to drive continuous improvement.
The partner company specializes in technical product development and manufacturing across a diverse portfolio. It operates in a dynamic, science-driven environment focused on innovation, optimization, and commercialization.
Independently prepare IRB documents, maintain regulatory files, and facilitate regulatory oversight of safety reporting for clinical trials.
Serve as the internal project manager for assigned oncology disease groups, providing timely updates and regulatory guidance.
Manage study activation processes and act as liaison between sponsors, investigators, and internal departments.
Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. Winship Cancer Institute is Georgia's only NCI-designated Comprehensive Cancer Center, dedicated to discovering cures for cancer and providing innovative therapies.
Lead a remote engineering team building impactful healthcare technology solutions.
Drive Agile development practices and collaborate with cross-functional teams.
Mentor engineers and ensure software quality, scalability, and compliance.
Our partner develops technology solutions that improve healthcare delivery and patient outcomes. They foster a collaborative, remote-friendly culture with a focus on professional growth and inclusive teamwork.
Develop project plans and execute to timelines and budget.
Serve as primary customer contact ensuring timely communication.
Ensure compliance with data onboarding protocols and operating procedures.
Beacon Biosignals is developing a leading at-home EEG platform to advance precision medicine for brain disorders. The company values asynchronous remote work and diversity, with a collaborative culture.
Provide regulatory advice and ensure compliance with U.S. regulations and ICH GCP guidelines for clinical research sites.
Coordinate IRB submissions, maintain regulatory documentation, and support site start-up and close-out activities.
Collaborate with cross-functional teams and monitor regulatory changes to advise stakeholders.
Care Access is working to make the future of health better for all by bringing 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, the company is dedicated to ensuring every person has the opportunity to understand their health and contribute to medical breakthroughs.
Design, program, and test software within a team to develop innovative solutions and products for clients.
Author and maintain documentation, develop prototypes, and drive release and post-release activities.
Collaborate with designers, build mobile APIs and web applications, and perform peer code reviews.
Robots and Pencils LP develops innovative software solutions and products for clients. The company is headquartered in Cleveland, OH, and fosters a collaborative culture of creativity and technical excellence.
Lead a team of product engineers to build the core developer experience of the Render platform.
Drive execution on key product initiatives, balancing speed with high reliability and quality.
Partner with Product and Design to translate customer needs into technical solutions.
Render builds a developer-first cloud platform for AI-native applications, eliminating the complexity of hyperscalers. With over 6 million developers and $257M in funding, the team values craft, velocity, and user experience.
Serve as a senior expert in computer system validation and computer software assurance, leading validation initiatives and developing reusable frameworks.
Establish and maintain validation strategies, methodologies, and documentation aligned with regulatory standards like cGxP, GAMP 5, and 21 CFR Part 11.
Mentor junior consultants and collaborate with QA, IT, and business stakeholders to ensure effective validation execution across client engagements.
The company is a consulting firm that provides validation and compliance services for life science manufacturers. They have a people-focused culture with opportunities for professional development and growth.
Own the full people management lifecycle, including hiring, performance reviews, and career development.
Manage multiple engineering teams, ensuring KPI delivery and proper staffing for commitments.
Partner with Product on priorities, schedules, and trade-offs while holding Tech Leads accountable for design quality.
Tenna provides a platform that revolutionizes construction equipment fleet operations. They are a team of quality-obsessed, gritty, continuous learners and collaborative problem solvers.
Oversee sterilization processes within medical devices and provide technical support across all certification schemes as a fully remote role.
Lead a team of MDR Product Assessors-Sterilization, manage resource planning, and drive team performance against global targets.
Develop and maintain sterilization QMS documentation aligned with best practices and applicable regulatory requirements.
SGS is the world's leading testing, inspection and certification company, recognized as a global benchmark for sustainability, quality, and integrity. With 99,600 employees operating a network of 2,600 offices and laboratories, we offer a dynamic, international work environment with a focus on professional development and sustainability.
Lead and manage the Clinical Solution Analyst team, overseeing resourcing, performance, and career development.
Act as a senior product subject matter expert, shaping solution design and providing delivery insights to inform the product roadmap.
Partner with Sales to support feasibility assessments and with customers to ensure successful onboarding and delivery.
Evinova is a health-tech business focused on accelerating better health outcomes through digital transformation in the life sciences sector. The company fosters a collaborative, fast-paced culture with a shared purpose to transform health through data and digital innovation.