Manufacturing, Training and 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

Manufacturing & Operations at EyePoint ensures the safe, compliant, and reliable production of innovative therapies for patients with serious retinal diseases. This team oversees end-to-end manufacturing, supply chain, and facilities with a strong focus on regulatory compliance, patient safety, and product integrity. Manufacturing & Operations strives to maintain rigorous standards and efficient processes with the goal of delivering safe, high-quality therapies to patients.

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.

Primary responsibilities include, but are not limited to, the following:
Individual 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.

Required Skills & Knowledge
Primary skills and knowledge required include, but are not limited to the following:

• Ability to translate complex regulatory requirements and data trends into simple, actionable manufacturing workflows.
• Experience with inspection readiness initiatives and in 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
  

Required Education & Experience
Level of Education Required:

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field (or an equivalent combination of education and hands-on manufacturing experience).

Number of Years of Experience in the Function and in the Industry:

• 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.

EyePoint is committed to fair andequitablecompensation practices. The salaryoffer iscommensuratewithEyePoint’scompensation philosophy and considers factors including but notlimited to education, training, experience, market conditions, criticality of the role and internal equity.

The target salary range for this position is listed below:

Salary Range

$94,760 - $119,480 USD

Envision Your Future

With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed topreventing blindnessby developing and commercializing innovative therapeutics.

The collective power of our values influences everything we do, and everything we do for you.

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.

EyePoint is proud to be an equal opportunity employer. We believe that diversity and inclusion among our colleagues is critical to our success as a company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. All applicants will be considered for employment without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.