Senior Quality Consultant - MedTech Services
Veeva Systems
Quality Assurance
Columbus, OH, USA
Posted on Friday, April 8, 2022
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 $2B 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
Are you driven and self-motivated? Are you passionate about bringing purpose-built technologies that enable greater compliance and process efficiencies to MedTech Companies? Are you looking for a collaborative work environment where you are encouraged to contribute and share your thoughts and ideas?
Veeva is looking for experienced professionals to implement Veeva Vault Quality solutions for our Medical Device and Diagnostic customers. The ideal candidate will utilize their industry experience to transform the way our customers collect, maintain, and Quality related processes and documentation. They will also contribute ideas and work with other Veeva team members to innovate and refine our internal processes, share feedback and work with our product team, and enhance our delivery model to meet the ever-changing needs of the MedTech industry.
This is a remote, full-time permanent role with Veeva. There is no work location requirement. This is a customer-facing role with a requirement for travel of up to 40%. Veeva Systems does not anticipate providing sponsorship for employment visa status for this employment position.
What You'll Do
- Lead Veeva Vault Quality implementations and handle project management responsibilities, such as resource planning, project risk management, leading cross-functional teams, and budget tracking & forecasting of the engagement
- Conduct Vault Design Review and Configuration workshops with MedTech stakeholders from Business and IT: gather requirements, design & prototype, configure and support the validation of the delivered Quality processes
- Work closely with customers’ business and IT stakeholders and develop scalable solutions that meet Quality regulatory compliance and customer requirements
- Mentor project team members and junior consultants
- Continue to develop industry knowledge and enhancements the delivery model to meet the changing business needs of Veeva and our customers
- Provide insight and recommendations to improve our technology and work closely with our Product team to ensure the best solutions for our customers
Requirements
- 8 + years of relevant work experience within Life Sciences, Healthcare, or other regulated industries (ex. Consumer Goods, Chemical, Cosmetics)
- Experience implementing, designing solutions, and supporting software applications
- Self-starter and motivated individual with the proven ability to work independently in a dynamic environment
- Intermediate knowledge of Quality related processes (e.g. CAPA, Complaints, Non-Conformance, Product Surveillance, Change Management)
- Understanding of compliance and computer systems validation requirements
- Proven ability to manage diverse customers and /or stakeholders and ability to communicate at multiple levels of the organization
- Ability to quickly understand customer requirements and create corresponding solution designs
- Knowledge of SaaS/Cloud software solutions
- Bachelor’s degree or equivalent work experience required
Nice to Have
- Work experience in Medical Devices and/or Diagnostics space
- Computer Science, Life Science, or related degree preferred.
- Strong knowledge of MedTech industry standards and regulatory requirements (e.g.: FDA QSR, ISO 13485, 21 CFR Part 11, 21 CFR 820, 210, GAMP)
- Direct experience with regulated systems or data-driven applications such as Veeva Vault solutions, NextDocs, Documentum, FirstDoc/FirstPoint, Trackwise, Medidata, Liquent Insight
- Experience with PLM and LIMs systems such as Arena, TeamCenter, Propel, Agilent, Labworks
- SaaS/Cloud delivery experience
- Experience in Services Delivery Management or Pre-Sales presentations and demonstrations
Perks & Benefits
- Allocations for continuous learning & development
- Health & wellness programs
- Flexible PTO
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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 talent_accommodations@veeva.com. Position may not be eligible for remote work in Colorado.
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