Manufacturing, Training and Compliance Lead

About the role

This team oversees end-to-end manufacturing, supply chain, and facilities with a strong focus on regulatory compliance, patient safety, and product integrity. The MFG Training and Compliance Lead will report to the AD of Manufacturing Training, Compliance and Operational Excellence and is responsible for the daily execution, coordination, and tracking of floor-level training programs and regulatory compliance activities. This role bridges the gap between regulatory requirements and plant floor operations, ensuring that all manufacturing personnel are fully qualified, compliant with cGMP/safety guidelines, and prepared for internal and external audits. This is a site-based role supporting our Northbridge Manufacturing facility. Travel to our other MFG locations may be required to support a multi-site team.

Responsibilities

• Training Execution & Coordination
  • On-the-Job Training (OJT): Coordinate and deliver technical on-the-job training and onboarding for manufacturing technicians and operators.
  • LMS Administration: Manage the site’s Learning Management System (LMS) to assign courses, log completions, and generate qualification reports.
  • Competency Assessment: Conduct routine performance evaluations and practical exams to certify that operators can safely and accurately run production equipment.
• Compliance Tracking & Audit Readiness
  • Curriculum Compliance: Monitor team training matrices daily to ensure no operator performs a task without active qualifications.
  • SOP & Documentation Review: Assist in writing, revising, and reviewing Standard Operating Procedures (SOPs), training logs, and logbooks to ensure they match current shop-floor practices.
  • Audit Support: Act as the primary point of contact for training documentation during regulatory inspections to quickly retrieve employee records.
• Deviation & CAPA Support
  • Root Cause Analysis: Partner with Quality and Operations teams to investigate manufacturing deviations linked to human error or lack of training.
  • Preventive Actions: Design and implement specific training interventions as part of Corrective and Preventive Actions (CAPAs) to prevent issue recurrence.

Requirements

• Ability to translate complex regulatory requirements and data trends into simple, actionable manufacturing workflows.
• Experience with inspection readiness initiatives and involvement with PAI inspections.
• Exceptional verbal and written communication skills to influence cross-functional stakeholders and present data to executive leadership.
• Proven track record of systematically resolving root causes of operational and compliance issues.
• Ability to work collaboratively in a fast-paced, dynamic work environment, while managing multiple priorities.
• Self-motivated, strong work ethic, strong organizational skills, strong communication skills, critical thinking, attention to detail and accuracy, the ability to work independently and in a team environment are essential.
• Flexible and able to respond quickly to shifting priorities and meet deadlines.
• Track record of strong personal performance combined with demonstrated ability to build and lead highly engaged teams in a high growth environment.

Qualifications

• Education: Bachelor’s degree in Engineering, Life Sciences, or a related technical field (or an equivalent combination of education and hands-on manufacturing experience).
• Experience: Minimum of 5 years of experience working in a highly regulated manufacturing environment (Pharmaceutical, Biotech, Medical Device, or Aerospace), with at least 2 years in a dedicated training, compliance, or coordinator capacity.

Pay

The target salary range for this position is $94,760 USD - $119,480 USD.

About the company

EyePoint is an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics. The collective power of our values influences everything we do:

• Transformational Innovation: We exist to change our patients’ lives through the power of sight. We are forward-looking, embrace challenges with curiosity, and continuously seek to improve our products and ourselves by learning, problem-solving, and pushing the limits of science and technology.
• Unwavering Integrity: We recognize our responsibility to our patients, employees, and our community, and value the trust they put in us. We set a high ethical bar and expect responsible leadership at every level to ensure we serve those who matter most to us.
• Compassionate Excellence: We believe that fun and excellence can coexist. We foster a culture where enjoying the work we do and caring for each other are as important as delivering exceptional outcomes.
• Inclusive Collaboration: We strive to see through the eyes of others and work as one team. We appreciate one another’s differences and perspectives, and ensure everyone feels valued, respected, and encouraged to bring their ideas forward.