Quality Operations Program Manager

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.   At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We're not just any public company – we made history in 2021 by becoming a public benefit corporation (PBC), legally bound to balancing the interests of customers, employees, society, and investors.   As a Work Anywhere company, we support your flexibility to work from home or in the office, so you can thrive in your ideal environment.   Join us in transforming the life sciences industry, committed to making a positive impact on its customers, employees, and communities.

The Role

The Quality Operations Program Manager role ensures the integrity, compliance, and management of Veeva’s processes within the Quality Management System (QMS). Serving as a process owner for document control, this role ensures processes are defined, monitored, assessed, and maintained across multiple product lines and regulated domains.

What You'll Do

• Act as a subject matter expert for the Document Control process area by owning the creation and lifecycle management of quality processes and records
• Provide quality oversight on regulated activities and deliverables, such as process definition, validation testing, and product releases/changes for in scope products and systems
• Provide technical expertise, regulatory interpretation, and direction regarding federal regulations, and other quality system requirements
• Develop appropriate metrics and track effectiveness and productivity of applicable domain systems

Requirements

• BS/BA in Science, Information Management, Engineering, related disciplines or equivalent industry experience
• 3+ years experience in a regulated quality role in Life Sciences
• Experience with Quality Management Systems (e.g., documentation and record management, training, change control, CAPA)
• Experience with electronic Document Management Systems (eDMS) and/or electronic Quality Management Systems (eQMS)
• Good understanding of GxP (GMP, GCP, etc.) regulations, principles of quality management systems in a regulated environment (21CFR 11, ICH Q10, QSR) and/or quality frameworks such as ISO9001