GMP Training & Compliance Lead

Initial Therapeutics, Inc.; Northbridge (MA); On-site; USD 95,000 - 119,000; Full time

Job summary

EyePoint Pharmaceuticals is seeking a MFG Training and Compliance Lead to ensure on-site training execution and regulatory readiness at the Northbridge facility. You will coordinate OJT, manage the LMS, and certify operator qualifications to uphold cGMP standards and audit readiness.

The role requires a strong background in regulated manufacturing, 5+ years in training/compliance, and proven ability to improve training programs and document control across a multi-site operation.

Qualifications

• Translate regulatory requirements into actionable manufacturing workflows.
• Experience with inspection readiness initiatives and involvement with PAI inspections.
• Exceptional verbal and written communication to influence stakeholders and present data to leadership.

Responsibilities

• Train and onboard manufacturing technicians and operators.
• Manage the site Learning Management System (LMS) and generate qualification reports.
• Conduct routine performance evaluations and practical exams to certify operators.
• Collaborate with Quality and Operations on training-related CAPAs and deviations.

Skills

Training delivery

LMS administration

Competency assessment

Regulatory compliance

SOP writing

Audit readiness

CAPA investigations

Education

Bachelor's degree in Engineering, Life Sciences, or related field

Tools

LMS

Job description

EyePoint Pharmaceuticals is seeking a MFG Training and Compliance Lead to ensure on-site training execution and regulatory readiness at the Northbridge facility. You will coordinate OJT, manage the LMS, and certify operator qualifications to uphold cGMP standards and audit readiness.

The role requires a strong background in regulated manufacturing, 5+ years in training/compliance, and proven ability to improve training programs and document control across a multi-site operation.