Quality Operations Leader - GMP & Regulatory Excellence

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

Job summary

EyePoint Pharmaceuticals seeks a Sr. Manager, Quality Operations to lead global GMP quality across development and commercial programs from our Northbridge site.

You will oversee the Quality Operations team ensuring product integrity, regulatory compliance, and continuous improvement in support of patient-focused therapies. Based in Northbridge with a hybrid schedule (in-office four days or more during milestone periods), you will drive quality systems, batch record review, release activities,

Qualifications

• Bachelor’s degree in scientific or technical discipline; master’s a plus.
• Minimum 10+ years in pharmaceutical/biotech QA operations.
• Experience with cGMP and FDA regulations in development to commercialization.

Responsibilities

• Builds, develops and leads the site Quality Operations team from PPQ to commercial manufacturing.
• Oversees incoming material release, batch record review, QC testing, and lot disposition.
• Collaborates with Quality and Manufacturing to align goals and priorities.
• Implements and maintains quality systems, SOPs, and regulatory compliance.
• Leads inspections readiness and QA review/approval of GMP documents.
• Mentors staff in quality best practices and corrective actions.

Skills

Leadership

GMP experience

Root cause analysis

Quality Assurance

Auditor certification

ERP systems

MES knowledge

Cross-functional

Problem solving

Education

Bachelor’s degree

Master’s degree preferred

Tools

ERP systems

MES systems

Job description

EyePoint Pharmaceuticals seeks a Sr. Manager, Quality Operations to lead global GMP quality across development and commercial programs from our Northbridge site.

You will oversee the Quality Operations team ensuring product integrity, regulatory compliance, and continuous improvement in support of patient-focused therapies. Based in Northbridge with a hybrid schedule (in-office four days or more during milestone periods), you will drive quality systems, batch record review, release activities,