Associate Director, MFG Training, Compliance and OpEx

Manufacturing & Operations

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.

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 work environment, while managing multiple priorities
• Self-motivated, strong work ethic, strong organizational skills, strong communication skills, critical thinking, attention to detail and accuracy, the ability to work independently and in a team environment are essential
• Flexible and able to respond quickly to shifting priorities and meet deadlines
• Track record of strong personal performance combined with demonstrated ability to build and lead highly engaged teams in a high growth environment