Director, Quality Systems

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 including RNAi silencing and RNA editing provides us with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology. Our diversified pipeline is focused on our obesity, alpha-1 antitrypsin deficiency and PNPLA3 I148M liver disease programs and includes clinical programs for Duchenne muscular dystrophy and Huntington’s disease, as well as several preclinical programs utilizing our versatile RNA medicines platform. 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: The Director, Quality Systems (QS) leads the internal team at Wave responsible for foundational quality processes: GXP Training, Document Control, Vendor Management, and Wave’s electronic Quality Management System (eQMS). This role is responsible for the continuous improvement and compliant operation of these processes to meet patient and business needs as Wave progresses from investigational products towards commercialization. This role is primarily focused on supporting GMP areas with some support of GXP. This is an onsite position requiring 4 days/week onsite presence at our Lexington facility.Experience: BS in a scientific disciplineMinimum 10-12 years’ experience in Quality Assurance in the pharmaceutical industry and 5 years managing personnelSignificant expertise with implementation and improvement of enterprise systems: Quality Management Systems, Documentation Systems, and Learning Management SystemsMinimum 3 years’ experience with Vendor Qualification and ManagementDemonstrated capability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleaguesAbility to identify technical problems and suggest resolution of the issuesStrong collaboration and communication skillsAbility to manage timelines for oneself and othersKnowledge of cGMP principles with respect to US, EU, and other relevant regulatory guidance and familiarity with drug development is a plus.Responsibilities: Improve and streamline existing QMS processes, such as Change Control, Deviations and CAPA Management, Document Management, GxP Training, and Vendor ManagementAssess current state of Quality Systems at Wave and develop a staged plan to arrive at inspection readinessDevelop a team of QS personnel fostering a culture of collaboration, continuous improvement and customer serviceOversee the development, maintenance, and optimization of QS policies, procedures, and templatesEnsure that all QS processes comply with applicable global regulatory requirements (e.g., FDA, EMA, ICH, etc.)Establish and monitor eQMS performance metrics to ensure process effectiveness and compliance.Lead cross-functional initiatives to identify and implement process improvements.Foster a culture of innovation and proactive problem-solving within the QS teamAct as a liaison between the QS team and other departments to ensure alignment of quality processes with business operationsCommunicate QS processes strategies, updates, and key metrics to senior leadership and other stakeholdersLead preparation and response activities for internal and external audits and regulatory inspectionsOther duties as assignedKey Skills:Hands-on self-starter with the ability to collaborate and work closely with various teams and line functions to ensure GMP standards and compliance with global regulationsDemonstrated ability to coach and develop personnelStrong change management skills with a customer service mindsetExcellent written, verbal and presentation skills for effectively interfacing with collaborators and customersAbility to assess and navigate complicated issues, break down the components, and devise practical short-term solutions while formulating long-term fixesStrong organizational skills with the ability to effectively multi-task and prioritizeAbility to adapt to changing business needs and meet timelines within a fast-paced environmentSelf-motivated with sound judgement and problem-solving skillsVeeva experience highly desiredExpertise in CSV principles through implementation of electronic systems desiredCombination product experience is a plusPay Range Disclosure Statement$193,000—$261,000 USDThe 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. 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