Senior Quality Operations Leader – GMP & Compliance

EyePoint; Northbridge (MA); Hybrid; USD 142,140 - 179,220; Full time

Benefits offered by this job

Hybrid work schedule

Job summary

EyePoint is seeking a Sr. Manager, Quality Operations to lead the global quality activities for development and commercial programs.

This in-person role at the Northbridge facility offers a hybrid schedule with three days in the office and potential for more during milestones. The role oversees site QA Operations, material release, batch review, QC testing, and QA oversight across internal and external manufacturing partners.

Qualifications

• Bachelor’s degree in scientific discipline or other technical field.
• 10+ years of related experience in pharmaceutical/biotech.
• Experience with Quality Assurance Operations in FDA-regulated environment.
• Experience auditing or auditor certification.

Responsibilities

• Lead the site quality operations team from process validation into commercial drug product manufacturing.
• Oversee material release, batch record review, QC testing, lot disposition, and quality event management.
• Collaborate with Quality and Manufacturing leadership to align goals and priorities.
• Develop and communicate team goals aligned with corporate objectives.
• Implement and maintain quality systems and cGMP-compliant procedures.

Skills

Leadership

GMP experience

Quality Assurance Operations

ERP knowledge

MES knowledge

Root cause analysis

Auditing

Education

Bachelor's degree

Master's degree (plus)

Tools

ERP

MES

Job description

EyePoint is seeking a Sr. Manager, Quality Operations to lead the global quality activities for development and commercial programs.

This in-person role at the Northbridge facility offers a hybrid schedule with three days in the office and potential for more during milestones. The role oversees site QA Operations, material release, batch review, QC testing, and QA oversight across internal and external manufacturing partners.