Senior Consultant - MedTech QMS

About the role

Veeva is looking for an experienced quality software consultant to lead implementations at Veeva's MedTech customers globally. The role guides the transformation of customers' Quality Management processes and technology, working closely with Professional Services teams to ensure delivery success across QMS implementations. It is a full-time position based in Boston, Massachusetts.

Key responsibilities

• Review and analyze existing customer business processes, identifying key steps, gaps and requirements that affect the implementation approach
• Lead QMS implementation workstreams for Veeva's MedTech Quality Management solutions
• Act as primary customer liaison, managing communication between implementation teams, customer stakeholders and third parties
• Analyze customer requirements and new product features to build adoption and enhancement roadmaps
• Guide customers in adopting Vault and industry best practices through post-implementation programs focused on continuous improvement

Required profile

• 6+ years of experience in GMP systems ownership or software consulting
• Experience in Life Sciences quality, manufacturing or healthcare
• Ability to understand business requirements and design creative solutions
• Excellent verbal and written communication skills

Required skills

• Strong understanding of FDA, EU MDR/IVDR requirements and reporting
• Understanding of Complaint Handling, CAPA, Nonconformance and Risk Management processes
• Knowledge of ISO 13485, 14971, FDA 21 CFR Parts 803, 820, 822, 806 and EU GMP Annex 11
• Nice to have: Veeva Vault implementation, management consulting, change management, field action and product return, and complaints management for medical devices

What we offer

• Base pay of $80,000 - $200,000, with possible variable bonus and/or stock bonus
• Medical, dental, vision and basic life insurance
• Flexible PTO and company-paid holidays
• Retirement programs and a 1% charitable giving program
• Work anywhere option, with flexibility to work from home or in the office