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Wave Life Sciences · 2 weeks ago

Manager, QA Training

Lexington, MA

Full-time

Onsite

Senior Level

$116K/yr - $156K/yr

7+ years exp

Wave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. The Manager, QA Training will oversee the GxP Training program, ensuring effective training that promotes employee competency and compliance readiness while collaborating with functional leaders.

BiotechnologyHealth CarePharmaceuticalTherapeutics

Comp. & Benefits

Responsibilities

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, 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 escalate 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

Qualification

GxP knowledgeQuality Systems principlesElectronic learning managementTraining program administrationGMP manufacturing experienceMS Office SuiteInstructional design principlesProcess improvementCommunication skillsOrganizational skills

Required

Bachelor's degree with a minimum of 7 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

Experience in training program administration

Experience working in a GMP manufacturing facility

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 improvement

Proficient with MS Office Suite including Word, Excel and PowerPoint