Manager / Sr. Manager, Quality Systems & Compliance
2 days ago
🏢 In-office - Bay Area
Description
• Responsible for the implementation and maintenance of Adicet’s Quality Management System (QMS). • Quality Business Process Owner for multiple quality systems and GxP compliance. • Mentor/coach junior QA team members on QMS requirements. • Own and manage the electronic Quality Management System (eQMS). • Lead implementation and maintenance of hybrid (electronic and paper-based) QMS. • Lead cross-functional teams to ensure alignment and compliance of QMS. • Identify and lead improvement opportunities in the QMS lifecycle. • Develop and provide tools and training for QMS processes. • Lead implementation and maintenance activities for eQMS. • Provide quality oversight and compliance for electronic systems. • Lead audits and inspections to ensure compliance.
Requirements
• BS preferred or related experience in life sciences including biology, immunology, biochemistry, process engineering or a similar biological science. • 4-6 years of experience in Quality Assurance/Systems, or related role within the biotech/pharmaceutical and/or cell/gene therapy industries. • 1-3 years of experience with supervising direct reports. • Strong knowledge GxP, ICH, GAMP-5, EU and CFR requirements and regulations. • Experience with implementing phase-appropriate hybrid GxP quality system processes and eQMS such as TrackWise, MasterControl, or Veeva. • Experience in leading audits and inspection readiness activities. • Excellent interpersonal, oral/written communication, collaboration and influencing skills. • Ability to lead cross-functionally across various levels of experience and management.
Benefits
• Company subsidized lunches (delivered onsite daily) • Onsite gym and various other fitness options • Abundant, zero-cost, onsite parking with electric vehicle charging stations • Free shuttle (Caltrain) • Fully stocked breakrooms
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