Sr/Manager, Training, Quality Systems

BioSpace; Northbridge (MA); On-site; USD 124,630 - 157,590; Full time

Job summary

A leading scientific organization is seeking a GxP Quality Training Manager to oversee training programs. This role involves managing training content development, collaborating with various departments, and ensuring compliance with regulatory standards. The ideal candidate has a Bachelor's degree, a deep understanding of GxP principles, and at least 2 years of experience in instructional design. This position supports both in-person and remote work, offering a hybrid schedule to promote flexibility.

Qualifications

• Proficient in translating complex technical concepts into clear training content.
• Demonstrated ability to train GxP personnel effectively.
• Experience in digital learning formats and instructional design.

Responsibilities

• Manage training program and curriculum related to Quality systems.
• Design and produce digital learning resources, including videos.
• Support audits and provide necessary training documentation.

Skills

Knowledge of GxP and Quality Systems principles

Ability to design engaging digital training content

Strong storytelling techniques

Excellent organization skills

Skills in MS Office Suite

Proficient in instructional design for adult learning

Education

Bachelor's Degree

Tools

Learning Management Systems

Job description

About EyePoint

Be Seen and Heard at EyePoint

• Focus on science and innovation, we aim to offer a lifetime of clearer vision.
• Commitment to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases.
• Delivery of innovative therapeutics to protect vision, specializing in sustained-release treatments for serious retinal diseases.

We offer 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.

Job Summary

This person will report to the Director of Quality Systems and be responsible for the GxP Quality Training program at EyePoint. This position will require the ability to build strong relationships with partner groups who support GLP, GCP and GMP activities to identify, enhance and support training needs.

This position can sit either at our Northbridge, MA site or Waterford, MA site. We offer a hybrid work schedule.

Responsibilities

• Manage the training program (guide, evaluate and implement the design and architecture of trainings within LMS).
• Creation and revision of role-based training curricula to align with functional responsibilities.
• Manage onboarding of new employees by facilitating Quality onboarding training, verifying account creation and assigning curricula in EyePoint's Learning Management System (LMS).
• Support the creation and revision of Training-related SOPs, work instructions, training materials in collaboration with Subject Matter Experts (SMEs).
• Design and produce digital learning resources, including web-based training, videos, and interactive modules.
• Co-create and curate self-paced training resources and multimedia assets (e.g., courses, programs, virtual/mixed reality).
• Advise subject matter experts (SMEs) on conceptualizing and sharing content.
• Provide training and support for employees on the use of the LMS.
• Responsible for the development of training material using instructional design principles that best suite various training objectives.
• Facilitate GxP training for employees, as needed.
• Oversight of training compliance across all departments, publish periodic training reports, and elevate compliance issues to management.
• Collaborate cross-functionally to support LMS upgrades and change management.
• Support the timely closure of relevant Quality System records.
• Identify and participate in initiatives to improve the training program, LMS and training content.
• Support development of Quality Management Review content to measure the effectiveness of the training program.
• Support audits and regulatory authority inspections by providing training reports/documentation or other assigned tasks.
• Provide oversight and timely response of training related inquiries.
• Oversight of employees' resumes/CVs, signature ID cards, and job descriptions to ensure compliance.
• Ensure timely generation and review of content for Annual GxP refresher trainings.

Other duties as assigned.

Qualifications

• Knowledge of GxP and Quality Systems principles with respect to US, EU, and other relevant regulatory guidance.
• Proven ability to design and develop engaging, detail-oriented digital training content that simplifies complex concepts; skilled in creating visually appealing materials with strong storytelling techniques and a keen eye for design.
• Ability to translate complex technical and scientific concepts into clear, engaging digital training content for diverse audiences, including technical experts and non-technical users; skilled in creating structured learning materials that simplify information without losing accuracy.
• Superior organization skills with ability to manage competing priorities and meet deadlines.
• Demonstrated ability to train GxP personnel one-on-one and in groups.
• Works independently with minimal supervision.
• Excellent team player with strong written and verbal communication skills.
• Ability to work cross-functionally while providing excellent customer service.
• Proficiency in instructional design principles for adult learning.
• Champions continuous process improvement.
• Proficient with MS Office Suite including Word, Excel and PowerPoint.

Other Requirements

• Experience in the administration of electronic learning management systems.
• Experience in training program administration in the life sciences industry or other highly regulated industry.

Education

Bachelor's Degree.

Experience

• Minimum 2+ years proven experience in instructional design and scripting for videotaping, audio, animated explainers, virtual reality and similar formats.
• Minimum 2+ years' experience with digital learning formats, e.g., as a content designer for office content and presentation tools, e-learning authoring tools, and/or learner response tools.
• Minimum 3 years of applying learning theory, design and expertise in adult learning techniques and education.

Compensation

The target salary range for this position is below.

Minimum: USD $124,630.00 per year.

Maximum: USD $157,590.00 per year.

Equal Opportunity Employer

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.

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.