Harrow

QA Engineer

• Partner closely with Harrow Eye’s External Manufacturing, Supply Chain and Regulatory Affairs team to ensure consistent and collaborative communication to external manufacturing partners.
• Work cross functionally to provide a single point of contact for QA technical support to internal team and external manufacturing partners.
• Effectively communicate issues, risks, and proposed solutions within the organization.
• Assist with, conduct and provide QA approval of investigations, CAPAs, changes, validation documentation, and other related GMP documentation.
• Provide communication, support, and guidance to manufacturing partners and within the QA CMO team.
• Facilitates implementation of policies and procedures for CMO compliance, including development of quality agreements. Quality business processes and product disposition in accordance with team derived strategy and business realities.
• Perform batch record review and lot disposition activities as required.
• Support internal and external audits as needed.
• Create and revise standard operating procedures as needed.
• Coach and mentor junior team members on a peer-to-peer level basis.
• Other duties as assigned.

Quality Assurance Specialist II

Program Manager

• Serve as project manager for external manufacturing activities, ensuring effective planning, scheduling, milestone tracking, and on-time delivery.
• Support technology transfer projects by coordinating cross-functional inputs from Tech Ops, QA, RA, and Supply Chain, and aligning deliverables with CMO execution.
• Manage day-to-day relationships with Contract Manufacturing Organizations (CMOs) to ensure alignment with business priorities and production requirements.
• Oversee project execution related to external manufacturing, including planning, scheduling, and milestone tracking.
• Monitor project progress, identify risks or delays, and implement corrective actions in collaboration with cross-functional teams.
• Act as primary liaison between internal stakeholders (Supply Chain, Quality, Regulatory, Technical Operations) and CMOs to ensure seamless coordination.
• Prepare and present regular project updates, performance metrics, and status reports to leadership.
• Support continuous improvement initiatives to enhance efficiency, reliability, and on-time delivery across external manufacturing operations.
• Ensure compliance with internal policies, contractual agreements, and regulatory standards in all CMO-related activities.

External Manufacturing Program Manager

Manager

• Lead and manage analytical testing and validation activities to support technology transfer of ophthalmic products to CMOs.
• Oversee the review, approval, and execution of analytical method development, qualification, validation, and transfer protocols and reports.
• Act as the primary analytical subject matter expert (SME) during technology transfer, scale-up, and validation activities.
• Partner with CMOs, Quality Control, Quality Assurance, MS&T, and Regulatory Affairs to ensure alignment on analytical requirements and deliverables.
• Review and provide technical input on tech transfer packages, analytical data, and regulatory submission documents.
• Troubleshoot analytical issues and provide scientifically sound solutions to ensure compliance, accuracy, and reproducibility.
• Monitor progress of analytical deliverables across multiple projects, ensuring timelines and quality standards are met.
• Develop and implement best practices, procedures, and continuous improvement initiatives for analytical testing and validation.
• Provide mentorship and guidance to team members, fostering professional growth and technical excellence.
• Ensure adherence to global regulatory standards, ICH guidelines, and company quality policies.

Manager/Lead – Analytical Test and Validation

Engineer

• Lead technology transfer of branded ophthalmic products to cGMP Contract Manufacturing Organizations (CMOs).
• Serve as the primary point of contact with CMOs and external partners for all technology transfer activities.
• Prepare, review, and approve technical documentation—including protocols, reports, and product/process validation packages (IQ, OQ, PQ)—to ensure accuracy and completeness.
• Provide technical leadership in CMO project transfer meetings, offering guidance and managing deliverables.
• Collaborate cross-functionally with MS&T, Quality Assurance, Quality Control, Supply Chain, and other departments to ensure seamless transfer and maintenance of processes at CMOs.
• Compile and analyze process data, communicate project status, identify trends, and meet internal and external reporting requirements.
• Support CMO selection by assessing manufacturing capabilities and driving initiatives to reduce and improve process variability.
• Troubleshoot and resolve manufacturing challenges by identifying root causes and implementing effective corrective actions.
• Provide process engineering recommendations to ensure transferred products are robust, compliant, and aligned with current manufacturing technologies.
• Partner with manufacturing teams to ensure compliance and product quality throughout the entire engineering and commercial operations process.
• Oversee product transitions into CMOs, ensuring readiness for production, quality assurance, and regulatory compliance.
• Serve as Subject Matter Expert (SME) for critical processes and provide technical leadership across the organization.

Quality Assurance Specialist II

External Manufacturing Program Manager

Manager/Lead – Analytical Test and Validation

Senior Process Engineer, MS&T