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Veeva

Posted 12 months ago

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Senior Consultant - MedTech QMS Complaints

BostonRemoteFull-time

AI Summary

Senior Consultant leading MedTech Complaints implementations for Veeva’s global MedTech customers, guiding transformation of Complaints Management processes and technology within QMS programs.

About this role

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $3B in revenue in our last fiscal year with extensive growth potential ahead.
At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We're not just any public company – we made history in 2021 by becoming a public benefit corporation (PBC), legally bound to balancing the interests of customers, employees, society, and investors.
As a Work Anywhere company, we support your flexibility to work from home or in the office, so you can thrive in your ideal environment.
Join us in transforming the life sciences industry, committed to making a positive impact on its customers, employees, and communities.

The Role

Veeva is looking for an experienced consultant to lead MedTech Complaints implementations at Veeva’s MedTech customers globally. This role will guide the transformation of our customers’ Complaints Management processes and technology. The MedTech Complaints consultant will work closely with Professional Services teams to ensure delivery success across QMS implementations.

What You'll Do

  • 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

    • Nice to Have

  • Veeva Vault implementation experience
  • Management Consulting
  • Change Management experience
  • Field Action and Product Return experience
  • Clinical Medical Device, Biologics, and SaMD experience

    • Perks & Benefits

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

    • Compensation

  • Base pay: $80,000 - $200,000
  • The salary range listed here has been provided to comply with local regulations and represents a potential base salary range for this role. Please note that actual salaries may vary within the range above or below, depending on experience and location. We look at compensation for each individual and base our offer on your unique qualifications, experience, and expected contributions. This position may also be eligible for other types of compensation in addition to base salary, such as variable bonus and/or stock bonus.

    • Skills

    CAPAComplaints ManagementEU GMP Annex 11FDA 21CFR Part 803FDA 21CFR Part 806FDA 21CFR Part 820FDA 21CFR Part 822GMP SystemsGxPISO 13485ISO 14971NonconformanceRisk ManagementSaaSVault

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