Senior Manager, Quality Document Control and Compliance
$150k - $160kScorpion Therapeutics
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 QDocs for GxP controlled documents Serve as Veeva Vault QDocs Administrator and document control manager Format finalized documents to ensure compliance with effective templates Proofread and finalize documents for final processing in Veeva QDocs Develop, update, manage, and maintain GxP controlled documents in coordination 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 troubleshooting Maintain document control compliance KPIs (periodic review) and compile/report metrics for management review Partner with IT on Veeva system change control (system process enhancements/improvements and new release validation) Serve as backup Veeva Quality Training Administrator and support creation of 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 Experience establishing effective KPIs for a document management system Experience creating and facilitating training for Quality Systems Skills / Attributes Strong written and verbal communication and interpersonal skills Commitment to supporting internal/external teams and customers Autonomy and initiative Meticulous attention to detail and strong organization Ability to multi-task, shift priorities, work in a fast‑paced environment, and solve problems Team player in a highly matrixed organization with professional demeanor, enthusiasm, and self-motivation Location & Travel San Francisco, CA or Cambridge, MA; ~15% travel Compensation / Benefits Base pay range: $150,000 - $160,000 annually (plus equity, bonus, and benefits) #J-18808-Ljbffr
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