Associate Director, MFG Training, Compliance and OpEx

Manufacturing & Operations at EyePoint ensures the safe, compliant, and reliable production of innovative therapies for patients with serious retinal diseases. This team oversees end-to-end manufacturing, supply chain, and facilities with a strong focus on regulatory compliance, patient safety, and product integrity. Manufacturing & Operations strives to maintain rigorous standards and efficient processes with the goal of delivering safe, high-quality therapies to patients.

The Associate Director, MFG Training, Compliance and OpEx will report to the VP Manufacturing and Operational Excellence and will lead the strategic design, implementation, and continuous improvement of manufacturing training programs, regulatory compliance frameworks, and Operational Excellence (Opex) initiatives. This role ensures the production workforce is highly skilled, fully compliant with international regulatory standards (e.g., FDA, EMA, ISO), and equipped to drive efficiency through Lean and Six Sigma methodologies.

This is a hybrid role supporting our Northbridge and Watertown facilities. We offer a hybrid work schedule. Travel to our MFG locations is required to support a multi-site team three days in-office but could be more at times as we approach upcoming critical milestones. May travel to external partner locations (5-10%).

• Audit Readiness: Collaborate cross functionally to ensure pre-approval inspection and commercial readiness activities are defined and completed. Serve as a primary subject matter expert (SME) during internal and external regulatory inspections.
• Quality Systems Management: Lead investigations into manufacturing deviations, establish Corrective and Preventive Actions (CAPAs), and ensure timely closure. In addition, support cross-functional teams in risk analysis associated with but not limited to Change Controls, complaint investigation, failure investigation (FMEA) and hazard assessments (HACCP).
• Documentation Control: Oversee the creation, review, and optimization of Standard Operating Procedures (SOPs) and Batch Records to eliminate compliance gaps.

• Program Architecture: Design and deploy site-wide technical training curricula, onboarding programs, and annual refresher courses.
• Matrix Tracking: Maintain the electronic Learning Management System (eLMS) to track qualification matrices, ensuring 100% training compliance before tasks are executed.
• Instructional Delivery: Partner with operations management to implement On-the-Job Training (OJT) and trainer-certification protocols.

• Lean Culture: Cultivate a site-wide culture of continuous improvement using Lean, 5S, Kaizen, and Value Stream Mapping (VSM).
• Waste Reduction: Identify bottlenecks in the production cycle to reduce scrap rates, optimize cycle times, and lower manufacturing costs.
• Key Metrics: Establish and monitor Departmental KPIs, including First Time Right (FTR), training compliance rates, and Opex savings.

• Team Development: Mentor and manage a team of training specialists, compliance coordinators, and continuous improvement engineers and drive cross site alignment and consistency.
• Cross-Functional Collaboration: Partner with Quality Assurance, Engineering, and Supply Chain leaders to align site goals.

• Leadership experience managing cross-functional teams with an ability to influence teams to prioritize activities and allocate resources without direct authority
• Ability to translate complex regulatory requirements and data trends into simple, actionable manufacturing workflows.
• Experience with inspection readiness initiatives and in involvement with PAI inspections
• Exceptional verbal and written communication skills to influence cross-functional stakeholders and present data to executive leadership.
• Proven track record of systematically resolving root causes of operational and compliance issues.
• Ability to work collaboratively in a fast-paced, dynamic…