Veeva Systems
Senior Consultant - Quality Systems CSV
Veeva is a mission-driven organization that aspires to help our customers in Life Sciences and Regulated industries bring their products to market, faster. We are shaped by our values: Do the Right Thing, Customer Success, Employee Success, and Speed. Our teams develop transformative cloud software, services, consulting, and data to make our customers more efficient and effective in everything they do. Veeva is a work anywhere company. You can work at home, at a customer site, or in an office on any given day. As a Public Benefit Corporation, you will also work for a company focused on making a positive impact on its customers, employees, and communities.
The Role
Veeva Systems is looking for a Senior Consultant with Validation experience to join the Professional Services team and provide validation guidance to our Development Cloud customers.
Candidates for this position will benefit from consulting experience, have spent time validating COTS systems, and have exposure to SaaS/cloud-based software. In this role, you will be leading initial and ongoing validation discussions, educating customers on validation methodologies, guiding customers on successful validation, and educating resources on CSV procedures and GDP.
What You'll Do
- Serve as the expert in the Vault validation methodologies in an internal and external capacity.
- Lead PQ/UAT validation of the Vault applications (COTS).
- Support the PQ validation template updates.
- Guide customers on the appropriate procedures needed for validation and post-go-live maintenance of the system.
- Liaise with Professional Services, Managed Services, and Customer Success Management to ensure the integrity of Customer Vaults validated state.
- Maintain and enhance Validation documentation.
- Mentor project teams and consultants in the R&D Services organization on CSV and GDP.
- Point of contact, along with the functional Practice Manager, for validation related queries.
- Translate and interpret industry guidance relating to validation.
- Represent Professional Services across multiple engagements.
Requirements
- 8+ years direct validation experience with SaaS/cloud-based software solutions in Quality, Clinical, Regulatory, Safety or other life science functions.
- Knowledge of computerized system validation (CSV), 21 CFR Part 11 compliance, GAMP-V, and risk-based validation procedures for COTS systems.
- Proven track record executing high-impact global system validations for life sciences as a validation lead.
- Proven ability to work with internal and external stakeholders and ensure delivery to a high degree of satisfaction.
- Ability and willingness to “roll up your sleeves” to design and execute validation documentation.
- Ability to quickly understand business requirements and create corresponding validation documentation.
- Proven ability to work independently in a dynamic, fast-moving environment.
- Expert on life sciences compliance and CSV requirements.
- Ability to travel up to 25%.
Nice to Have
- Direct experience with Veeva Vault.
- Experience leading and growing a validation team.
- Life Science, computer science, technology or related degree.
- SaaS/Cloud experience.
- Experience in services delivery management.
#RemoteUK
Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world.
Veeva is committed to fostering a culture of inclusion and growing a diverse workforce. Diversity makes us stronger. It comes in many forms. Gender, race, ethnicity, religion, politics, sexual orientation, age, disability and life experience shape us all into unique individuals. We value people for the individuals they are and the contributions they can bring to our teams.
Veeva Systems - Cloud-Based Business Solutions for the Global Life Sciences Industry
- Founded
- Founded 2007
- Employees
- 500+ employees
- Industry
- Internet Software & Services
Consultant