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Genezen · 3 weeks ago

Lead, Quality Systems

Lexington, MA

Full-time

Onsite

Mid, Senior Level

$110K/yr - $130K/yr

5+ years exp

Genezen is a company in the field of gene therapy, dedicated to meeting the needs of clients by providing process development and producing GMP viral vectors. The Quality Systems Lead will manage and enhance the Quality Management System, ensuring compliance and supporting cross-functional teams to achieve quality objectives.

BiotechnologyGeneticsManufacturing

No H1B

Responsibilities

Design and Manage system QMS workflows to ensure optimal functionality and alignment with organizational needs

Provide training and coaching to employees on the use of the electronic QMS system, ensuring they understand and adhere to its processes and features

Troubleshoot and resolve issues related to the electronic QMS, working closely with IT, internal departments, and system vendors as needed

Generate and analyze reports from the electronic QMS to monitor system performance and identify areas for improvement

Track and report on KPIs relative to the QMS

Facilitate the Change Control Review Board Meetings in accordance with internal procedures

Manage the Change Control process, ensuring that all changes to the QMS and related processes are properly documented, evaluated, and approved

Review QMS records, including Deviations, CAPA, Change Control, Effectiveness Checks, and Extension Requests, to ensure they are thorough, and adhere to established procedures

Offer guidance and support to staff across the organization to improve robustness of QMS records

Support the development and implementation of risk assessment methodologies and tools

Facilitate risk assessment activities and ensure risks are identified, evaluated, and mitigated effectively

Document and communicate risk assessment findings to relevant stakeholders

Prepare for and support internal and external audits and inspections by performing walk throughs and supporting internal audits

Work with cross functional teams to develop action plans to address audit findings and non-conformities

Act as a primary point of contact for auditors, providing necessary documentation and information

Stay current with applicable regulations, guidelines, and industry standards (e.g., FDA, EMA, ICH) and ensure all Quality Systems are compliant

Engage in regulatory surveillance initiatives

Prepare for, and participate in, regulatory inspections and audits

Own continuous improvement initiatives within the Quality Systems function to enhance efficiency, effectiveness, and compliance

Support cross-functional teams in identifying and implementing process improvements across the organization

Qualification

Quality Management System (QMS)Regulatory ComplianceCAPA ManagementChange ControlEQMS Software (Veeva)Risk AssessmentProject ManagementProblem-SolvingCommunication Skills