Senior Quality Operations Leader — GMP & Manufacturing

EyePoint; Northbridge (MA); Hybrid; USD 142,000 - 179,000; Full time

Job summary

EyePoint seeks a Sr. Manager of Quality Operations to lead the Northbridge site QA/Operations in a hybrid role. You will supervise the team across validation, commercial production, and release activities, ensuring cGMP compliance and regulatory readiness for development and commercial programs.

The role demands 10+ years in pharma/biotech QA operations, strong leadership, and experience with external CMOs. Salary range reflects EyePoint’s compensation philosophy and the role’s criticality.

Qualifications

• Bachelor’s degree in a scientific discipline or technical field is required.
• Minimum of 10+ years of related experience in pharmaceutical or biotechnology industries, preferably in development and Quality Assurance Operations.
• Experience auditing or holding auditor certification.
• Experience overseeing CMO operations.
• Combination device experience and strong leadership, talent assessment and development skills.
• Knowledge of electronic manufacturing support systems including ERP and MES is highly desirable.

Responsibilities

• Build and lead the Northbridge site Quality Operations team from validation through commercial manufacturing.
• Oversee material release, batch record review, QC testing, lot disposition, and APQR/documentation.
• Interface with Quality, Manufacturing, CMC, and Supply Chain; support QA reviews of cGMP documents.
• Ensure compliance with cGMP and FDA regulatory standards; participate in inspections.
• Develop training and foster continuous improvement and operational efficiency.

Skills

Leadership experience

GMP experience

Problem solving

Cross-functional collaboration

Regulatory compliance

Education

Bachelor’s degree

Master’s degree preferred

Tools

ERP systems

MES systems

Job description

EyePoint seeks a Sr. Manager of Quality Operations to lead the Northbridge site QA/Operations in a hybrid role. You will supervise the team across validation, commercial production, and release activities, ensuring cGMP compliance and regulatory readiness for development and commercial programs.

The role demands 10+ years in pharma/biotech QA operations, strong leadership, and experience with external CMOs. Salary range reflects EyePoint’s compensation philosophy and the role’s criticality.