Quality Assurance Specialist III, QA Training

Quality Assurance Specialist III, QA Training

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Wave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Our RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders. Our toolkit of RNA-targeting modalities includes editing, splicing, RNA interference and antisense silencing, providing us with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology.

Our diversified pipeline includes clinical programs in Duchenne muscular dystrophy, Alpha‑1 antitrypsin deficiency, Huntington’s disease, obesity and a preclinical program in NASH/MASH. Driven by the calling to “Reimagine Possible,” we are leading the charge toward a world in which human potential is no longer hindered by the burden of disease.

As a member of Wave’s Quality Assurance (QA) team, the Quality Assurance Specialist III, QA Training will be responsible for the oversight and maintenance of Wave’s GxP Training program. This role partners with functional leaders to develop and maintain effective training that promotes employee competency and compliance readiness. This is an in‑person role onsite at our Lexington facility requiring a minimum of 4 days onsite.

• Bachelor’s degree with a minimum of 4 years of related or transferable experience in the pharmaceutical or biotechnology industry, preferably in Quality Assurance/Training
• Experience in the administration of electronic learning management systems (Veeva and/or Compliance Wire preferred)
• Experience in training program administration
• Experience working in a GMP manufacturing facility

• Manage the training program
• 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 Wave’s Learning Management System
• Support the creation and revision of Training related SOPs, work instructions, and training materials in collaboration with Subject Matter Experts (SMEs)
• Provide training and support for employees on the use of the Learning Management System (LMS)
• Support the development of training materials such as quizzes, instructor‑led courses, and on‑the‑job training
• 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, vendor releases, and change management
• Manage or 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 health and effectiveness of the training program
• Support audits and regulatory authority inspections by providing training reports/documentation or other assigned tasks
• Oversight and timely response of training related inquiries
• Other duties as assigned
• Ensure timely completion of annual training review by providing support to functional leads and escalating issues to management
• Oversight of employees’ CVs and job descriptions to ensure compliance
• Ensure timely generation and review of content for Annual GMP refresher training

• Knowledge of GxP and Quality Systems principles with respect to US, EU, and other relevant regulatory guidance
• 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
• Knowledge of instructional design principles for adult learning
• Champions continuous process…