Senior Consultant - MedTech QMS Complaints

About the role

Review and analyze existing Customer business process and identify key process steps, gaps, and requirements that would impact implementation approach.
Lead QMS Complaints 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.

Responsibilities

• Review and analyze existing Customer business process and identify key process steps, gaps, and requirements that would impact implementation approach
• Lead QMS Complaints 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

Requirements

• 8+ years of experience in GMP Systems ownership or Software Consulting
• 5+ years of experience in Complaints Management for Medical Device
• 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
• Proven track record leading implementation and/or IT operations as a consultant, business analyst, or IT lead and/or business sponsor
• Proven ability to work both independently and in teams in a dynamic, fast-moving environment
• Good understanding of SaaS and GxP principles
• Able to quickly understand business requirements and design creative solutions

Qualifications

• Excellent verbal and written communication skills
• Experience in the Life Sciences Quality, Manufacturing, or Healthcare spaces
• Experience with Data or Content Management applications
• Veeva Vault implementation experience
• Management Consulting
• Change Management experience
• Field Action and Product Return experience
• Clinical Medical Device, Biologics, and SaMD experience

Skills

• Strong understanding of FDA, EU MDR/IVDR requirements and Reporting
• Knowledge of ISO 13485 and 14971, FDA 21CFR Part 803, 820, 822, 806, EU GMP Annex 11
• Excellent verbal and written communication skills
• Experience in the Life Sciences Quality, Manufacturing, or Healthcare spaces
• Experience with Data or Content Management applications
• Veeva Vault implementation experience
• Management Consulting
• Change Management experience
• Field Action and Product Return experience
• Clinical Medical Device, Biologics, and SaMD experience

Benefits

• Medical, dental, vision, and basic life insurance
• Flexible PTO and company paid holidays
• Retailer programs
• 1% charitable giving program

Pay

Base pay: $80,000 - $200,000

Schedule

Full-time