Veeva

Senior Consultant - MedTech QMS Complaints

Reposted 15 Hours Ago

Be an Early Applicant

Hiring Remotely in Boston MA USA

In-Office or Remote

80K-200K Annually

Senior level

Big Data • Cloud • Healthtech • Software • Big Data Analytics

The software company powering the path to the world’s new medicines.

The Role

Lead MedTech Complaints implementations for Veeva's customers analyzing business processes managing communication and guiding adoption of best practices.

Summary Generated by Built In

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: $80000 - $200000
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.

#LI-RemoteUS

#LI-MidSenior

Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world.

Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race color sex sexual orientation gender identity or expression religion national origin or ancestry age disability marital status pregnancy protected veteran status protected genetic information political affiliation or any other characteristics protected by local laws regulations or ordinances. If you need assistance or accommodation due to a disability or special need when applying for a role or in our recruitment process please contact us at [email protected].

Top Skills

Eu Mdr/Ivdr

Fda

Fda 21Cfr Part 803

Fda 21Cfr Part 806

Fda 21Cfr Part 820

Fda 21Cfr Part 822

Gxp

Iso 13485

Iso 14971

SaaS

View all jobs at Veeva

View Veeva Profile

Report Job

Am I A Good Fit?

beta

Get Personalized Job Insights.

Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.

The Company

HQ: Pleasanton CA

6000 Employees

Year Founded: 2007

What We Do

Veeva is the global leader in cloud software for the life sciences industry. Committed to innovation product excellence and customer success Veeva serves more than 1000 customers ranging from the world’s largest pharmaceutical companies to emerging biotechs. As a Public Benefit Corporation Veeva is committed to balancing the interests of all stakeholders including customers employees shareholders and the industries it serves.