QA Validation Manager/ Sr. Manager Jobs Seattle, WA
Job Duties:
*Oversee all functions of the internal validation department by managing, developing implementing validation protocols test procedures to ensure products are meet FDA/EMEA requirements
*Act as an individual contributor to managing validation activities associated with process, equipment, analytical method, facility, cleaning computer system related projects
*Develop and recommend validation strategies to provide evidence that a system, equpiment, analytical method or process has been validated
*Manage, review and approve change control for process, equipment, facility, analytical method, cleaning and computerized systems
*Prepare training materials and provide formal in-house trainings on validation programs
*Interact with internal/external auditors
Job Requirements:
*BA/BS Degree
*8-10 years of validation experience in the biotech industry with biologic products
*Experience managing and operating an internal corporate validation program for biologic products (validation protocols/reports, SOPs, risk assesments other GXP documentation
*Experience working with commercial/clinical products as well as medical devices
*Experience defending validation practices during regulatory inspections
*Must have knowledge of international regulatory guidance and practices related to validation applications and principles
*Experience with MS Word, Excel, Powerpoint, Acess, Project, FileMaker and Visio