Sr. Lead Trainer / Supervisor, Documentation Management and Training (DMT) - EyePoint Pharmaceuticals, Inc.

Be Seen and Heard at EyePoint Pharmaceuticals

At EyePoint, leadership trusts our employees to get the job done. The patient-centric and award-winning approach we’re taking in business fuels our success for:

• preventing blindness through vision-saving medications
• delivering best-in-class proprietary pharmaceutical technologies
• transforming ocular drug delivery

We See You.

Your wellbeing

Your professional worth

Your future at EyePoint

EyePoint offers robust total rewards in a science-based entrepreneurial culture that empowers curiosity and innovation to help catapult your career. There’s space for every voice and perspective to be heard in our on-site and remote environments where a variety of strengths and diverse backgrounds are connected.

This position will report to the Manager, Quality Engineer and located at our Northbridge, MA facility and also support the Watertown, MA site.

Support GxP and general business training processes, including training development and delivery. Ensure the learning management process is aligned with company policies and regulatory requirements. Identify improvement opportunities and drive process enhancements.  Manage day-to-day activities within the Document Management and Training (DMT) functions.

• Designs, develops, and facilitates or delivers general site and technical training content (including cGMP training), including instructional tools and hands-on exercises. Evaluates training needs and participates in the acquisition or development of training materials company-wide.
• Partners cross-functionally with business groups to develop employee job training requirements, providing guidance and consulting as required. Collaborates across functional areas, assisting in development of training materials and knowledge assessments, for area SOPs.
• Is business owner of the Learning Management and Documents Management processes within the QMS, providing training/support to system users. Collaborates with QMS Administrator to resolve issues and implement enhancements. Facilitates the maintenance of personnel historical training records.
• Implements strategic business objectives in driving quality, compliance, and organizational effectiveness.
• Analyzes processes, identifies enhancements, and actively drives continuous improvement of training programs and processes.
• Develops and maintains training performance metrics and continuously evaluates the effectiveness of training programs. Tracks status of compliance to training requirements and reports to management periodically or as requested.
• Assists GMP work areas in developing, implementing, and maintaining On-the-Job Training (OJT) programs.
• Provides new hire GMP training for all site employees.
• Maintains current expertise in applicable regulatory authority requirements.
• Participates in inspection readiness activities. During inspections, may interact with regulatory inspectors regarding training policies, procedures, and documentation.
• Actively promotes safety rules and awareness. Demonstrates good safety practices at all times including the appropriate use of protective equipment. Reports and takes initiative to correct safety & environmental hazards.
• Provide support for electronic Quality Management System (QMS) configuration, user requirements/ enhancement requests, and period computer system validations.

• Experience developing, delivering and assessing classroom, computer-based, and competency-based function training
• Proficient in the use of MS Word, Excel, and PowerPoint
• Solid organizational and time management skills; demonstrated project management capability, exceptional presentation and facilitation skills
• Excellent written, verbal, and interpersonal communication skills
• Possesses experience in pharmaceutical cGMP regulated environment
• Working knowledge of pharmaceutical industry regulations and expectations
• Non-routine scheduled work may be required on evenings, weekends
• Familiar with implementing and validating GxP computerized systems, including knowledge of regulations, guidance, good practices on electronic record, electronic signatures, and data integrity (e.g. 21 CFR Part 11, EU Annex 11, GAMP5, etc.) is a plus

Level of Education:  Bachelor's Degree

Number of Years of Experience in the function and in the industry:

5+ years of experience as a trainer, preferably in pharma/biotech

2 years people management experience is required

Direct experience in courseware development and delivery, including eLearning/CBT applications and design principles required

Strong proficiency in the management of electronic learning management systems / electronic Quality Management Systems (QMS), AssurX is highly preferred

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.

• Success begins with our People
• Patients First
• Integrity
• Results-Driven
• Innovation
• Team Focus
• Diversity & Inclusion

EyePoint Pharmaceuticals 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.

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