Senior Consultant – MedTech QMS Complaints

🕒 il y a 2 mois

❄️ Minnesota – Distant

❄️ Minnesota – Remote

💵 $80 000 - $200 000 / an

⏰ Temps Plein

🟠 Senior

💼 Consultant

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Veeva Systems

Site WebLinkedInTous les Emplois

1001 - 5000 employés

☁️ SaaS

⚕️ Assurance santé

💊 Pharmaceutique

SaaS • Healthcare Insurance • Pharmaceuticals

Veeva Systems Inc. est un leader des logiciels cloud pour l’industrie mondiale des sciences de la vie. Animée par l’innovation, l’excellence produit et la réussite de ses clients, Veeva compte plus de 875 clients, des plus grands groupes pharmaceutiques aux biotechs émergentes. Le siège de Veeva est situé dans la région de la baie de San Francisco, avec des bureaux au Canada, en Europe, en Asie et en Amérique latine. Veeva vise 10 000 collaborateurs d’ici 2025 : consultez la section Offres d’emploi pour nos postes ouverts et notez que toute correspondance adressée aux nouveaux candidats ou aux candidats en cours ne proviendra que d’une adresse e‑mail officielle @veeva.com.

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

🎯 Exigences

• 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

🏖️ Avantages

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