Senior Technical Lead
Job Summary
Experienced in validating GxP GEN AI based solutions, the full-time Senior Technical Lead will manage multiple dispositions for J&J Managers, oversee end-to-end processes in the pharmaceutical industry, and provide validation guidance while working remotely.
Key Responsibilities
- Validate GxP GEN AI based solutions and LSMV Safety and Pharmacovigilance systems
- Manage end-to-end processes including inventory, assessments, remediations, and final dispositions
- Write and execute documentation for validation deliverables, including compliance plans and test protocols
Required Qualifications
- 7-10 years of relevant experience in the pharmaceutical, biotechnology, or medical device industry
- Experience in FDA and/or global regulated environments with a strong understanding of GxP standards
- Proven ability to lead and advise junior and senior resources
- Experience in QA methodologies and designing test plans and procedures
- Strong skills in writing and executing validation documentation
Complete Job Description
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