Remote MedTech QMS Lead Consultant (GMP/FDA)

Veeva Systems, Inc.; Pleasanton (CA); Remote; USD 80.000 - 200.000; Vollzeit

Benefits dieser Stelle

Medical, dental, vision, and basicLife

Flexible PTO and company holidays

Retirement programs

1% charitable giving program

Zusammenfassung

Veeva Systems is seeking an experienced quality software consultant to lead QMS implementations for MedTech customers worldwide. You will guide the transformation of our customers’ Quality Management processes and technology, working closely with Professional Services to ensure delivery success across QMS implementations.

You’ll advise on Vault adoption, regulatory compliance, CAPA and risk management, and help customers realize value through post-implementation improvements.

Qualifikationen

• 6+ years of experience in GMP Systems ownership or Software Consulting.
• Strong understanding of FDA, EU MDR/IVDR requirements and Reporting
• Understanding of relationship between Complaint Handling, CAPA, Nonconformance and Risk Management processes
• Knowledge of ISO 13485 and 14971, FDA 21CFR Part 803, 820, 822, 806, EU GMP Annex 11
• Ability to understand business requirements and design creative solutions
• Excellent verbal and written communication skills
• Experience in the Life Sciences Quality, Manufacturing, or Healthcare spaces

Aufgaben

• Review and analyze existing Customer business process and identify key process steps, gaps, and requirements that would impact implementation approach
• Lead QMS implementation workstreams at our customers for Veeva’s MedTech Quality Management solutions
• Function as a Primary customer liaison managing communication between implementation teams, customer stakeholders, and 3rd parties
• Analyze customer requirements and new product features to develop customer adoption and enhancement roadmaps
• Guide customers in adopting Vault and industry best practices as part of post-implementation programs focused on the holistic success and continuous improvement of the customer

Kenntnisse

GMP Systems Ownership

Regulatory Knowledge

Quality Management

Software Consulting

Life Sciences

Tools

Veeva Vault

Jobbeschreibung

Veeva Systems is seeking an experienced quality software consultant to lead QMS implementations for MedTech customers worldwide. You will guide the transformation of our customers’ Quality Management processes and technology, working closely with Professional Services to ensure delivery success across QMS implementations.

You’ll advise on Vault adoption, regulatory compliance, CAPA and risk management, and help customers realize value through post-implementation improvements.