CSV Lead with GenAI, Agentic QMS Experience (W2 ONLY)

Job Details:
Experience in the Pharmaceutical, biotechnology, or medical device industry
2+ years experience with System Development Lifecyle
3+ years experience in Computer System Validation Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.
Knowledge of FDA guidance s and industry standards (i.e., GAMP)
Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports
Experience in QA Methodologies, designing, reviewing and approving User Stories, Test Plans and Reports, System and UAT test scripts, Test procedures, Traceability Matrix, and Design Specs.
Strong verbal and written communication skills.
Ability to lead a team. Ability to work with remote teams and support several changes/projects simultaneously.
Ability to provide Validation guidance, timely reviews, and escalations to TQ management.
Ability to work with global project teams during the initial project planning phases
Ability to provide guidance on validation strategy and be able to handle the highly fluid state of the project

In addition to validation and regulation experience, the resource should have the following experience:

Experience with Validation of GEN AI solutions in GxP environment is key.
Look for someone who has supported CSV AI projects