Manufacturing, Training and Compliance Lead

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

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 and equitable compensation practices. The salary offer is commensurate with EyePoint’s compensation philosophy and considers factors including but not limited 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 to preventing blindness by 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.