Senior Manager, Quality Document Control and Compliance Responsibilities Lead and manage the daily activities of Veeva Vault QDocs and overall document management process and compliance Create and process document change control (DCC) documentation in Veeva for GxP controlled documents Serve as Veeva Vault QDocs Administrator and document control manager Format finalized documents to ensure compliance with effective templates Perform proofreading and finalize documents for final processing in Veeva QDocs Develop, update, manage, and maintain GxP controlled documents with functional area representatives Develop SOPs and work instructions (WIs) to support Quality Systems and Veeva document control processes Assist and train end users in Veeva to execute document review, approval, and troubleshoot as needed Maintain document control compliance KPIs (periodic review) and compile/report metrics for management review Partner with IT on Veeva system change control (process enhancements/improvements and new release validation) Serve as backup Veeva Quality Training Administrator and support training assignments as needed Perform other duties and complete special projects as required Qualifications / Requirements Bachelor’s Degree required Experience managing and maintaining GxP compliance documents and document control systems Strong knowledge of GxP/FDA regulations and experience supporting regulatory inspections 8+ years of industry experience 2+ years as Veeva Vault QDocs Administrator Preferred / Additional Experience establishing effective KPIs for document management systems Experience creating and facilitating training for Quality Systems Skills / Attributes Strong written and verbal communication and interpersonal skills Autonomy and initiative Meticulous attention to detail and strong organization Ability to multitask, shift priorities, and solve problems in a fast-paced environment Ability to collaborate effectively in a highly matrixed organization Compensation/Benefits Base pay range: $150,000–$160,000 annually (plus equity, bonus, and benefits) Location/Travel San Francisco, CA or Cambridge, MA; ~15% travel #J-18808-Ljbffr
Senior Manager, Quality Document Control And Compliance
SCORPION THERAPEUTICS
oaxaca de juárez, oaxaca de juárez
Publicado hace 7 días
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