Job Description
The role provides strategic and operationalQAleadership with accountability forQuality Operations,Quality Systems, and CMCQuality oversightat the Miltenyi San José site. It covers allCDMO businessand the manufacturing of own assetsspanningfromGMP starting materialsthrough topatient ready drug products.
The role provides oversight ofQMSmaintenance and batch releaseactivities,supplier quality,management of health authority inspections and client audits, technical transfers as well as the support ofclient commercialization programs.
The role will be responsible forbuilding, maintaining and developing a high performing team as well asproviding in depth and broad scientific/technical expertise and the direction and management of compliance related programs.
Essential Duties and Responsibilities
Planning
- Lead efforts to ensure that the site is inspection ready at all times and is meeting customer deadlines.
- Allocate appropriat...
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