Manufacturing Training & Compliance Leader - Audit-Ready Ops

BioSpace; Northbridge (MA); On-site; USD 95,000 - 119,000; Full time

Job summary

EyePoint Pharmaceuticals seeks a MFG Training and Compliance Lead for our Northbridge Manufacturing facility in Massachusetts. You will ensure floor-level training and regulatory compliance, qualifying personnel and maintaining audit readiness in a fast-paced, high-regulation environment.

You will coordinate OJT, manage the LMS, perform competency assessments, review SOPs, and contribute to CAPA activities, partnering with Quality and Operations to sustain product integrity and patient safety.

Qualifications

• Translate complex regulatory requirements into actionable manufacturing workflows.
• Involvement with inspection readiness initiatives and PAI inspections.
• Exceptional verbal and written communication to influence stakeholders and leadership.
• Proven track record of resolving root causes of operational and compliance issues.
• Ability to manage multiple priorities in a fast-paced environment while leading teams.

Responsibilities

• Coordinate and deliver on-the-job training for manufacturing technicians and operators.
• Manage the Learning Management System (LMS) to assign courses, log completions, and generate reports.
• Monitor training matrices and ensure active qualifications for all operators.
• Assist in SOP reviews, training logs, and documentation to reflect current practices.
• Support audit documentation during regulatory inspections as primary contact.
• Partner with Quality and Operations on CAPA to prevent recurrence.

Skills

Regulatory translation

Inspection readiness

Communication

Root cause analysis

Cross-functional collaboration

Prioritization

Attention to detail

Team leadership

Education

Bachelor's degree in Engineering/Life Sciences/related field

Job description

EyePoint Pharmaceuticals seeks a MFG Training and Compliance Lead for our Northbridge Manufacturing facility in Massachusetts. You will ensure floor-level training and regulatory compliance, qualifying personnel and maintaining audit readiness in a fast-paced, high-regulation environment.

You will coordinate OJT, manage the LMS, perform competency assessments, review SOPs, and contribute to CAPA activities, partnering with Quality and Operations to sustain product integrity and patient safety.