Senior Consultant, MedTech QMS Complaints

September 16

🍂 Massachusetts – Remote

Although this job is listed in Massachusetts, this company may be open to hiring remote in other states.

💵 $80k - $200k / year

⏰ Full Time

🟠 Senior

💼 Consultant

🦅 H1B Visa Sponsor

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Veeva Systems

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SaaS • Healthcare Insurance • Pharmaceuticals

Veeva Systems is a cloud-computing company focused on the global life sciences industry. It provides software, data, and consulting services to streamline research and development, quality management, regulatory operations, and commercial processes. Veeva's solutions encompass clinical trials, regulatory submissions, drug safety management, and commercial execution to support life sciences enterprises in their mission to improve and extend life.

1001 - 5000 employees

☁️ SaaS

⚕️ Healthcare Insurance

💊 Pharmaceuticals

📋 Description

• 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 Project Management, GMP Systems ownership, or Software Consulting • 4+ 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 Lifesciences 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