Associate Director, MFG Training, Compliance and OpEx

About the role

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.

Responsibilities

• Lead the development and execution of comprehensive training programs for the manufacturing workforce to ensure full compliance with international regulatory standards (e.g., FDA, EMA, ISO).
• Design and implement regulatory compliance frameworks to ensure all operations meet regulatory requirements.
• Drive Operational Excellence initiatives to enhance efficiency through Lean and Six Sigma methodologies.
• Ensure the production workforce is highly skilled and equipped to drive efficiency through Lean and Six Sigma methodologies.
• Support the Northbridge and Watertown facilities with a hybrid work schedule, including occasional travel to MFG locations and external partner locations (5-10%) as needed.

Requirements

• Bachelor's degree in a relevant field such as Biotechnology, Engineering, or Life Sciences.
• Minimum 8 years of experience in pharmaceutical manufacturing, quality assurance, or related fields.
• Proven track record in training program development and execution.
• Experience in regulatory compliance and operational excellence.
• Strong understanding of industry standards and regulations (e.g., FDA, EMA, ISO).
• Excellent communication and interpersonal skills.
• Ability to manage multiple projects simultaneously and prioritize tasks effectively.

Qualifications

• Master's degree in a relevant field such as Biotechnology, Engineering, or Life Sciences preferred.
• Experience leading cross-functional teams and driving process improvements.
• Knowledge of Lean and Six Sigma methodologies.
• Experience in implementing and maintaining regulatory compliance frameworks.

Skills

• Strong organizational and project management skills.
• Excellent written and verbal communication skills.
• Ability to work independently and as part of a team.
• Proficiency in Microsoft Office Suite.

Benefits

EyePoint offers a competitive benefits package including health insurance, retirement plans, and paid time off. The company also provides a hybrid work schedule and occasional travel to support a multi-site team.

Pay

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 $150,380 - $190,207 USD.

Schedule

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.