Upvote
Downvote
Manager, Quality Engineering, Cell Therapy
Share Job
- Suggest Revision
Full-time
- From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.
- Position SummaryThe Quality Engineering team is responsible for quality oversight of engineering and validation lifecycle activities, including facility, equipment, and utility commissioning and qualification, computer systems validation, process validation, and technology transfer.
- The Digital Quality Manager, Quality Engineering is responsible for quality oversight of computer systems validation (CSV) activities.
- Key ResponsibilitiesReview and approve computer systems validation (CSV) lifecycle documentation associated with manufacturing site computerized and enterprise systems, including but not limited to system classification, user requirements, functional specifications, installation qualification, operational qualification / system testing, user acceptance testing, performance qualification, and periodic review.
- Owns and leads the administration and maintenance of the site technical review board and IT change management process, assuring consistency with establishing standards for local and global change control systemsAct as SME and/or Quality reviewer/approver for risk assessments, data integrity assessments, and technical reports supporting qualification.
Active Job
Updated TodaySimilar Job
Relevance
Active