Sr. Project Manager - Validation and Data Integrity

Location: San Mateo, California
Job title: Sr. Project Manager - Validation and Data Integrity
Location: San Mateo, CA (Local candidates preferred)
Contract position
Work with pharmaceutical partners and platform providers to facilitate the development of remediation plans, and train and support the execution of the plan.
-Perform Data Integrity assessments and document the results based on industry best practices
Support, train, and execute a remediation approach that can be utilized across operations
-Work with Subject Matter Experts to document user requirements
-Update application system User Requirements, Functional, and Design Specifications
-Develop Installation Qualifications based on Design
-Develop Operation Qualifications based on functional requirements
-Develop Performance Qualification scripts based on configuration
-Route validation documentation
-Manage Tasks based on aggressive timelines and interact with multiple stake holders
Skills and Experience
-10+ years’ experience in computer systems validation within the Life Science and Pharma industries in the areas of Quality Assurance, IT, and Manufacturing
-Thorough understanding of the principles of computer systems validation, SDLC, VLC methodologies
-Knowledge of cGxP, GDP, GAMP, 21CFR Part11, Annex 11, MHRA guidance, and industry best practices
-Understanding of existing and new business processes and requirements to ensure proper implementation and validation of systems
-Strong communication and interpersonal skills interacting with business, peers, and vendors
-Consistently meet the agreed quality and time goals
Education: BA / BS information systems, engineering, science or business
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