Job Description
Job Description
This individual will provide thought-leadership, expertise, and management of managed validation services to the IT Validation & Compliance infrastructure in a Contract Development and Manufacturing Organization (CDMO) setting. Individual will be responsible for the validation review and approval of enterprise software validation lifecycle deliverables and the validation technical oversite of change controls, CAPAs, and deviations associated with enterprise software. Working closely with partners in Quality Validation, this individual provides strategic and technical expertise for all global software validation related matters, including assurance that all aspects comply with cGMPs, legal, regulatory requirements, and the KBI internal requirements.
Job Responsibilities:
Provide oversight of enterprise software validation from a global perspective.
Provide validation direction, guidance, review, and approval for validation lifecycl...