Facebook pixel

Validation Lead
Commercial Products
Confirmed live in the last 24 hours
Locations
Columbus, OH, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Agile
Management
SAP
Requirements
  • Bachelor's degree in Engineering/Sciences or equivalent relevant technical experience
  • At least 5+ years of experience in CSV role
  • Hands-on experience with the validation of commercial enterprise applications (e.g., SFDC, SAP) used in the conduct of commercial regulated activities (Good Distribution Practice)
  • Good understanding of the commercial industry regulations (e.g., PDMA, OIG, Sunshine Act, 21CFR203)
  • Knowledge of Agile software development, and software testing methodologies
  • Excellent written and oral communication skills, good decision-making skills, and time management skills
Responsibilities
  • Lead and execute (as needed) the validation activities for Veeva's general releases, hotfixes, as well as product periodic revalidation
  • Responsible for tracking, monitoring, and controlling the validation process
  • To ensure timely delivery to meet pre-scheduled release dates and budgets
  • Provide technical expertise, regulatory interpretation, and direction in regard to computer validation, federal regulations, and other quality system requirements
  • Closely collaborate with Product Team to ensure requirements/specifications are defined in a clear, testable, and compliant format
  • Effectively work with cross-functional teams (Product Management, SQA, Technical Operations) to ensure the validated state of the system is maintained
  • Ensure requirements are adequately tested following a risk-based approach
  • Identify and log issues found during validation execution. Work closely with Product and SQA teams to identify and prioritize issues early on and track validation incidents to closure
  • Ensure clear traceability against all testing performed
  • Create/update CSV deliverables including IQ/OQ, VPP, VSR, Trace Matrices
  • Independent pre and post-execution review of validation test scripts
  • Coordinates with cross-functional teams to design and execute test protocols
  • Supports change control as validation technical resource and ensures timely completion of required tasks
  • Perform validation impact analysis and risk assessments in conjunction with product teams
  • Execute other projects/duties as assigned to ensure compliance across Veeva's product line and internal business systems
Desired Qualifications
  • Experience with cloud-based applications and/or infrastructure compliance
  • Understanding of Agile development methodology
  • Working knowledge of GAMP 5
  • Broader awareness or direct experience with “promotional materials” requirements (e.g., OPDP, APLB)
Veeva Systems

1,001-5,000 employees

Cloud computing services for pharmaceutical companies.
Company mission
Veep's mission is to help R&D, quality, and regulatory teams eliminate inefficiencies and bring high-quality, safe, sustainable products to market without compromising quality. The company builds cloud-based tools for pharmaceutical research.
Benefits
  • Parental leave
  • PTO
  • Free food
  • Health, dental, & vision insurance
  • Gym membership reimbursement
Company Values
  • Do the Right Thing
  • Customer Success
  • Employee Success
  • Speed