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%).

Primary responsibilities include, but are not limited to, the following:

Individual Responsibilities

Regulatory Compliance & Quality Assurance

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.

Workforce Training & Competency Development

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.

Operational Excellence (Opex) & Continuous Improvement

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.

Leadership & People Management

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.

Required Skills & Knowledge

Primary skills and knowledge required include, but are not limited to the following:

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

Six Sigma Green Belt or Black Belt certification is highly preferred. Lean Master or PMP certification is a strong asset.

Demonstrated management skills, including leadership, talent assessment, recruitment, employee retention and development

Required Education & Experience

Bachelor’s degree required in Engineering, Life Sciences, Business Operations, or a related technical field. Master’s degree or MBA is a plus.

Minimum of 10 years of related experience in the pharmaceutical, biotechnology or Medical Device industry, with at least 5 years in a leadership or supervisory role.

EyePoint is committed to fair and equitable compensation practices. The salary offer is commensurate with EyePoint’s compensation philosophy and considers factors including but not limited to education, training, experience, market conditions, criticality of the role and internal equity.

The target salary range for this position is listed below:

Salary Range

$150,380—$190,207 USD

With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics.

The collective power of our values influences everything we do, and everything we do for you.

We exist to change our patients’ lives through the power of sight. We are forward looking, embrace challenges with curiosity, and continuously seek to improve our products and ourselves by learning, problem-solving and pushing the limits of science and technology.

We recognize our responsibility to our patients, employees, and our community, and value the trust they put in us. We set a high ethical bar and expect responsible leadership at every level to ensure we serve those who matter most to us.

We believe that fun and excellence can coexist. We foster a culture where enjoying the work we do and caring for each other are as important as delivering exceptional outcomes.

We strive to see through the eyes of others and work as one team. We appreciate one another’s differences and perspectives, and ensure everyone feels valued, respected and encouraged to bring their ideas forward.

EyePoint is proud to be an equal opportunity employer. We believe that diversity and inclusion among our colleagues is critical to our success as a company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. All applicants will be considered for employment without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.