Minneapolis, MN30+ days ago
What You'll DoReview and analyze existing Customer business process and identify key process steps, gaps, and requirements that would impact implementation approachLead QMS Complaints implementation workstreams at our customers for Veeva's MedTech Quality Management solutionsFunction as a Primary customer liaison managing communication between implementation teams, customer stakeholders, and 3rd partiesAnalyze customer requirements and new product features to develop customer adoption and enhancement roadmapsGuide customers in adopting Vault and industry best practices as part of post-implementation programs focused on the holistic success and continuous improvement of the customerRequirements8+ years of experience in Project Management, GMP Systems ownership, or Software Consulting4+ years of experience in Complaints Management for Medical DeviceStrong understanding of FDA, EU MDR/IVDR requirements and ReportingUnderstanding of relationship between Complaint Handling, CAPA, Nonconformance and Risk Management processesKnowledge of ISO 13485 and 14971, FDA 21CFR Part 803, 820 , 822, 806, EU GMP Annex 11Proven track record leading implementation and/or IT operations as a consultant, business analyst, or IT lead and/or business sponsorProven ability to work both independently and in teams in a dynamic, fast-moving environmentGood understanding of SaaS and GxP principlesAbility to quickly understand business requirements and design creative solutionsExcellent verbal and written communication skillsExperience in the Lifesciences Quality, Manufacturing, or Healthcare spacesExperience with Data or Content Management applicationsNice to HaveVeeva Vault implementation experienceManagement ConsultingChange Management experienceField Action and Product Return experienceClinical Medical Device, Biologics, and SaMD experiencePerks & BenefitsMedical, dental, vision, and basic life insuranceFlexible PTO and company paid holidaysRetirement programs1% charitable giving programCompensationBase pay: $80,000 - $200,000The salary range listed here has been provided to comply with local regulations and represents a potential base salary range for this role. Senior Consultant - MedTech QMS ComplaintsMinnesota - MinneapolisProfessional Services - Services : R&D Svcs /Full-Time /RemoteApply for this jobVeeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster.