Summary

The Cell and Gene Therapy External Quality Lead (CGT) Lead will be responsible for leading and managing the external quality assurance, ensuring compliance with global quality standards and regulatory requirements. This role oversees quality-related activities with external partners, including Contract Manufacturing Organizations (CMOs) and suppliers, and develops and implements supplier quality management strategies. The role holds these responsibilities in the Cell and Gene Therapy manufacturing plants.
This role can be located on-site in Morris Plains, NJ or Durham, NC. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

365 days a year, we aspire to be the best manufacturer of Cell & Gene therapies to ensure our patients have the treatments they need to live longer, healthier lives.

• External Quality Management: Lead and manage the external quality assurance team, ensuring compliance with global quality standards and regulatory requirements. Oversee quality-related activities with external partners, including CMOs and suppliers.
• Supplier Quality Management: Develop and implement supplier quality management strategies. Participate in supplier audits, manage discrepant material escalations, and ensure effective communication and collaboration with suppliers.
• External Partnerships Management: Collaborate with and manage external partnerships, including material suppliers, service providers, and CMO stakeholders. Ensure the establishment and management of quality-related agreements.
• CMO Quality Activities Support: Govern Key Quality Indicators (KQIs) as defined in agreements and act as a front-facing leader to CMO partners, ensuring effective communication and collaboration.
• Firewall Administration Governance: Oversee the administration of firewalls to ensure secure and compliant operations.
• Compliance and Documentation: Ensure all quality-related documentation is accurate, up-to-date, and compliant with internal and external regulatory standards. Manage quality-related agreements and oversee change control processes.
• Metrics and Reporting: Provide regular metrics and trending reports on quality performance. Identify critical compliance and business-related issues and develop remediation strategies using a risk management approach.
• Stakeholder Collaboration: Partner with internal stakeholders such as supply chain, manufacturing operations, regulatory affairs, and global quality functions to support and execute quality initiatives. Act as a front-facing leader to CMO partners and manage escalations related to external quality issues.
• Inspection Support: Support onsite inspections and ensure the facility is inspection-ready.
• Compliance and Business Issue Resolution: Identify critical compliance and business-related issues related to the supply of materials or services. Develop and implement remediation strategies using a risk management-based approach.
• Escalations and Inspections Leadership: Lead escalations related to external quality for critical issues and support onsite inspections to ensure compliance and readiness.

• A Bachelor's degree in scientific or technical field preferably in Chemistry, Biology, Engineering, or a similar discipline
• 10 years' experience in biopharmaceutical based GMP manufacturing operations quality assurance including direct experience in external management programs for biotechnology manufacturing facilities
• Proven track record in supplier quality management and external quality assurance.
• Experience in managing quality-related activities with Contract Manufacturing Organizations (CMOs) and suppliers.