At Veeva, we build enterprise cloud technology that powers the biggest names in the pharmaceutical, biotech, consumer goods, chemical & cosmetics industries. Our customers make vaccines, life-saving medicines, and life-enhancing products that make a difference in everyday lives. Our technology has transformed these industries; enabling them to get critical products and services to market faster. Our core values, Do the Right Thing, Customer Success, Employee Success, and Speed, guide us as we make our customers more efficient and effective in everything they do.
Veeva Systems is looking for a Validation Lead with Validation experience to join the Professional Services team and provide validation guidance to our R&D 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, members of the team 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 R&D Professional Services across multiple engagements.
- 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%.
- 4-year degree required.
- Qualified candidates must be legally authorized to be employed in the United States. Veeva Systems does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
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.
- Locality to major life sciences customer hub (NJ; Boston, MA; San Francisco, CA; Philadelphia, PA; Chicago, IL)
Perks & Benefits
- Flexible PTO
- Allocations for continuous learning & development
- Health & wellness programs
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.