We are looking to hire a Quality Manager who lives and breathes computer systems quality and regulatory compliance. As a key member of our young and dynamic team, you will be responsible for maintaining our corporate Quality Management System(QMS) that promotes customer satisfaction and positively impacts our company performance as well as:
- Implementing and maintaining company QMS policies, SOPs and validation templates.
- Managing and coordinating computer systems quality, privacy, security and 21 CFR Part 11 assessments as well as internal and client audits.
- Providing quality oversight for critical business projects.
- Maintaining Corrective and Preventive Actions (CAPA) program.
- Consulting, mentoring and training project teams on quality management, regulatory compliance and validation deliverables.
- Bachelor’s degree with at least 5 years of relevant experience in software quality management, regulatory compliance and validation.
- Strong interpersonal and communication skills as well as experience working in a global team environment.
- Prior experience working with 21CFR Part 11, GXP, Agile SDLC and computer system validation.
- Prior experience working with quality management systems in regulated environments such as pharma or medical devices.
About DrugDev, Inc.
The most important medical research should be backed by the best technology: innovation that reduces costs, speeds timelines, and delivers new treatments sooner. DrugDev is transforming the clinical trial landscape with modern SaaS solutions that enable companies to “do more trials” through industry-wide collaboration, standardization and a beautiful technology experience.