The Industry Cloud for Life Sciences

Director – Computer Systems Validation

DirectorDirectorFull TimeRemoteTeam 1,001-5,000H1B SponsorCompany Site LinkedIn

Location

Massachusetts

Posted

127 days ago

Salary

$130K - $230K / year

Bachelor Degree10 yrs expEnglishGoogle Cloud Platform

Job Description

• Manage/mentor a validation team of validation program managers / team leads (direct reports) on validation projects of Veeva and internal business systems to ensure deliverables conform to company and regulatory requirements. • Responsible to deliver validation projects under strict deadlines to ensure customer success. Review and approve validation approach, method, and reporting (VPP, VIA, VSR) during periodic releases of Veeva software products. • Establish validation processes commensurate with the level of risk and manage the execution of validation projects whose scope, regulatory visibility, schedule requirements, and complexity require coordination with customers, collaborators, and quality. • Oversee on-shore and off-shore team of validation contractors testing of Veeva products to ensure deliverables conform to defined budgets and timelines. • Act as executive management interface between Product Development, Operations, Security, and Quality Assurance/Compliance regarding Computer Systems validation exigencies and problem resolution. • Support planning and execution of product and internal system periodic reviews. • Execute other projects/duties as assigned to ensure compliance across Veeva’s product line and internal business systems.

Job Requirements

Knowledge of Software Engineering and Quality Assurance generally attained through studies resulting in a B.S., in engineering/sciences, a related discipline, or its equivalent and applicable industry experience.
A minimum of 10+ years directly relevant experience in validation of enterprise software, computer information systems used in life sciences regulated environment (GMP, GCP, GLP, GvP)
Previous managerial experience (5+) which demonstrates proficiency in selection, motivating and retaining a superior team, effectively managing personnel issues and planning and administering financial resources.
Demonstrated understanding of ERES regulations (e.g., 21 CFR Part 11, etc.)
Applied experience (i.e., through validation activities, audit support, and/or software system/software product compliance evaluation) in GCPs (e.g., ICH E6, 21 CFR 56, etc.),GMPs (e.g., 21 CRF 211, 21 CFR 820, etc.)
Use and/or development of risk-based, critical thinking decision-making models to inform validation related activities.
Excellent project management, communication, and technical writing skills are required.
The successful candidate will possess the professionalism and technical competency required to represent the department before our customers, regulatory agencies, and management.
Proven ability working in a matrix environment and leading multi-level / cross functional teams to achieve the highest performance in meeting site and departmental objectives.