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
Ability to quickly understand business requirements and design creative solutions
Excellent verbal and written communication skills
Experience in the Life Sciences Quality, Manufacturing, or Healthcare spaces
Experience with Data or Content Management applications

Benefits

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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

GMP Systems ownershipComplaints ManagementFDA requirementsEU MDRISO 13485ISO 14971FDA 21CFR Part 803FDA 21CFR Part 820FDA 21CFR Part 822FDA 21CFR Part 806

Soft Skills

communicationindependent workteam collaborationproblem-solvingadaptabilityleadershipcustomer liaisonanalytical thinkingcreative solution designcontinuous improvement