Manager, External Operations

Role Summary

The External Operations Manager will oversee manufacturing across Tonix’s product portfolio, manage relationships with external partners, and drive operational excellence for our commercial product portfolio. The role includes development, manufacturing, and the management of quality systems related to manufacturing supply, ensuring compliance with quality and regulatory standards. We are seeking a dynamic, experienced professional with hands-on manufacturing operations experience, experience with technology transfer, and a track record of collaborating with external organizations and cross-functional teams.

Responsibilities

• Manage product life cycle activities across Tonix product portfolio.
• Author and revise process documentation for GMP products.
• Lead continuous process verification activities to ensure product consistency and quality.
• Analyze process data and implement improvements in collaboration with external partners.
• Perform risk tools and manage mitigations related to process performance, supply continuity, and change management activities.
• Provide SME support and engage with cross-functional stakeholders as needed.
• Manage quality systems (CAPAs, change controls, deviations, and investigations).
• Support validation activities related to process, packaging, and ship qualification activities.
• Manage project execution in collaboration with CMC Development leads, Supply Chain, Quality, and Regulatory Affairs Contract Manufacturing Oversight.
• Oversee CMOs to ensure compliance with Tonix manufacturing processes and testing.
• Maintain routine meetings with external supply partners, manage agendas, and follow up on action items.
• Conduct visits to CMOs and supply partner sites to ensure adherence to contractual agreements.
• Develop and implement performance metrics to evaluate CMO performance.
• Review supplier documentation and contracts to provide SME input.
• Manage and communicate CMO performance to ensure timely execution of issues and projects related to business objectives.
• Execute deliverables to support projects such as new supplier requests, material part requests, etc.
• Support Regulatory and Quality related audits as a technical SME for commercial products.
• Participate in cross-functional meetings to discuss product quality, product supply, process improvements, and provide project updates.
• Collaborate with stakeholders to address quality-related issues and drive continuous improvement against business objectives.

Qualifications

• Minimum of 8 years of experience, or an equivalent combination of education and experience, in pharmaceutical or biotechnology.
• Strong knowledge of regulatory requirements and guidelines (e.g., FDA, EMA, ICH).
• Hands-on experience with manufacturing operations and documentation (such as batch records, protocols, etc.) supporting the production of medical devices or medicines.
• Experience as an owner of quality systems such as change control, deviation, CAPA, and validation activities.
• Experience using GMP electronic systems (Veeva, TrackWise, Netsuite, TrackWise, SAP etc.).
• Ability to work effectively in a cross-functional team environment.
• Strong analytical and problem-solving skills.

Education

• BS, MS, or Ph.D. in a relevant scientific field (e.g., chemistry, biology, engineering) or equivalent work experience.