Manufacturing Training & Compliance Leader

Initial Therapeutics, Inc.; Northbridge (MA); Hybrid; USD 150,380 - 190,207; Full time

Job summary

EyePoint offers a hybrid role for an Associate Director, MFG Training, Compliance and OpEx to design and implement training programs, regulatory frameworks, and continuous improvement initiatives for ophthalmology manufacturing.

The role oversees audit readiness, CAPAs, documentation, and KPI tracking while driving Lean and Six Sigma across Northbridge and Watertown facilities. Travel to partner sites is 5–10%.

Qualifications

• Bachelor’s degree required in Engineering, Life Sciences, Business Operations, or related technical field.
• Minimum of 10 years in pharma/biotech/medical device with ≥5 years in leadership.
• Experience with inspection readiness and regulatory inspections.
• Strong communication and cross-functional leadership skills.

Responsibilities

• Audit readiness: lead cross-functional readiness for inspections and serve as SME during regulatory inspections.
• Quality systems: manage investigations, CAPAs, and risk analysis activities.
• Documentation: oversee SOPs and batch records to close compliance gaps.
• Program architecture: design site-wide training curricula and onboarding programs.
• eLMS & OJT: maintain qualification matrices and implement trainer-certification protocols.
• Opex: apply Lean, 5S, Kaizen, and VSM to improve processes and reduce waste.
• Leadership: mentor training specialists and drive cross-site alignment.
• Collaboration: align goals with QA, Engineering, and Supply Chain.

Skills

Leadership

Regulatory knowledge

Training programs

Lean Six Sigma

Project management

Quality systems

Cross-functional

Communication

Change control

Risk analysis

Education

Bachelor's degree in Engineering

Bachelor's degree in Life Sciences

Master’s degree / MBA

Tools

eLMS

Job description

EyePoint offers a hybrid role for an Associate Director, MFG Training, Compliance and OpEx to design and implement training programs, regulatory frameworks, and continuous improvement initiatives for ophthalmology manufacturing.

The role oversees audit readiness, CAPAs, documentation, and KPI tracking while driving Lean and Six Sigma across Northbridge and Watertown facilities. Travel to partner sites is 5–10%.