Quality Assurance Specialist III, QA Training bei Wave

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 and Huntington’s disease, as well as a clinical program in 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.

Description

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.

Experience

• 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 ComplianceWire is preferred
• Experience in training program administration
• Experience working in a GMP manufacturing facility

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

Key Skills

• 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

Pay Range External Disclosure Statement

The annual base salary range for this position is $102,000 - $138,000

The range provided is based on what we believe is a reasonable estimate for the annual base salary pay range for this position at the time of posting. Actual annual base salary will vary based on several factors including, but not limited to, relevant skills, experience, qualifications, position criticality, and internal equity.  This position is eligible for a discretionary annual bonus and discretionary stock-based long-term incentives.  In addition to compensation, Wave offers a comprehensive and competitive range of benefits designed to support our employees’ and their families physical and financial health and overall well-being. These include, but are not limited to, company-sponsored medical, dental, vision, life, long and short-term disability insurances, generous paid time off (including a week-long company shutdown in the Summer and the Winter), 401K participation with matching contributions, and Employee Stock Purchase Program.

Wave Life Sciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Wave Life Sciences complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Wave Life Sciences expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. Improper interference with the ability of Wave Life Sciences’ employees to perform their job duties may result in discipline up to and including discharge.

We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Wave Life Sciences, USA.