Senior Consultant - MedTech QMS Complaints at Veeva Systems

Philadelphia, Pennsylvania, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

MedTech, Life SciencesIndustries

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
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

Responsibilities

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

Skills

Key technologies and capabilities for this role

Veeva VaultQMSComplaints ManagementMedTechBusiness Process AnalysisImplementation ConsultingRequirements AnalysisCustomer LiaisonQuality ManagementAdoption Roadmaps

Questions & Answers

Common questions about this position

What is the salary for the Senior Consultant - MedTech QMS Complaints role?

This information is not specified in the job description.

Is this a remote position, and what is the location policy?

Veeva Systems is a Work Anywhere company, supporting flexibility to work from home or in the office so you can thrive in your ideal environment.

What are the key requirements and skills needed for this role?

The role requires 8+ years of experience in Project Management, GMP Systems ownership, or Software Consulting; 4+ years in Complaints Management for Medical Device; strong understanding of FDA, EU MDR/IVDR requirements; and knowledge of ISO 13485, 14971, and related regulations, along with excellent communication skills.

What are Veeva Systems' core values and company culture like?

At the heart of Veeva are values: Do the Right Thing, Customer Success, Employee Success, and Speed; the company is a public benefit corporation balancing interests of customers, employees, society, and investors, with a mission-driven focus on transforming life sciences.

What makes a strong candidate for this Senior Consultant position?

Strong candidates have a proven track record leading implementations as a consultant, business analyst, or IT lead; ability to work independently and in teams in a fast-moving environment; and experience in Lifesciences Quality with SaaS and GxP principles.

Veeva Systems

Quality and regulatory software solutions provider

About Veeva Systems

Veeva Systems offers software solutions for quality, regulatory, and advertising claims management, focusing on consumer products and chemical companies. Their cloud-based platform provides visibility and traceability throughout the product journey, ensuring compliance with regulations and accelerating time-to-market. Unlike competitors, Veeva has specialized expertise in both the Life Sciences and Chemical sectors, allowing them to effectively address industry-specific challenges. The company's goal is to help clients efficiently bring safe and compliant products to market.

Pleasanton, CaliforniaHeadquarters

2007Year Founded

$6.8MTotal Funding

IPOCompany Stage

Enterprise Software, Healthcare, Consumer GoodsIndustries

5,001-10,000Employees

Benefits

Parental leave

PTO

Free food

Health, dental, & vision insurance

Gym membership reimbursement

Risks

Manual processes in medtech content management risk compliance issues and market delays.

GenAI features in Vault CRM may face data privacy and security challenges.

Rapid product expansion could lead to integration challenges and customer dissatisfaction.

Differentiation

Veeva Systems specializes in cloud-based software for the life sciences industry.

The company offers a subscription-based model ensuring continuous updates and improvements.

Veeva's Vault CRM Suite connects sales, marketing, and medical for customer-centric engagement.

Upsides

Veeva Compass Patient platform supports patient journey analysis and market sizing.

GenAI features in Vault CRM enhance field productivity with contextual task automation.

Veeva's digital HACCP solution improves safety and efficiency in compliance processes.

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