Lead, Quality Systems

Genezen is a gene therapy company that provides process development, produces GMP viral vectors, and provides cell transduction for gene and cell therapy clinical trials. We are looking for a Quality Systems Lead to administer and enhance our Quality Management System (QMS) with a focus on electronic QMS support, risk assessments, inspection readiness, and compliance activities.

Requirements

• Design and manage system QMS workflows
• Provide training and coaching to employees on the use of the electronic QMS system
• Troubleshoot and resolve issues related to the electronic QMS
• Generate and analyze reports from the electronic QMS
• Track and report on KPIs relative to the QMS
• Facilitate the Change Control Review Board Meetings
• Manage the Change Control process
• Review QMS records
• Offer guidance and support to staff across the organization
• Support the development and implementation of risk assessment methodologies and tools
• Facilitate risk assessment activities
• Document and communicate risk assessment findings
• Prepare for and support internal and external audits and inspections
• Work with cross functional teams to develop action plans
• Act as a primary point of contact for auditors
• Stay current with applicable regulations, guidelines, and industry standards
• Engage in regulatory surveillance initiatives
• Prepare for, and participate in, regulatory inspections and audits
• Own continuous improvement initiatives within the Quality Systems function
• Support cross-functional teams in identifying and implementing process improvements

Benefits

• Paid vacation days
• Paid sick time
• 10 observed holidays
• 2 floating holiday
• 1 volunteer day
• 401(k) plan with company match
• Share Appreciation Rights
• Choice of several healthcare plans
• FSA and HSA programs
• Dental & vision care
• Employer-paid basic term life/personal accident insurance
• Voluntary disability, universal life/personal accident insurance
• Accidental Death & Dismemberment (AD&D) Insurance