{"id":1493768,"url":"https://alion.io/job/wave-life-sciences-director-quality-systems","title":"Director, Quality Systems","company":{"id":1948484,"name":"Wave Life Sciences","domain":"wavelifesciences.com","url":"https://alion.io/company/wave-life-sciences","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":null},"role":"Science & Research","role_family":"Science & Research","seniority":"head","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Lexington, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":193000,"max":261000,"currency":"USD","period":"year","gross":null,"usd_annual":261000},"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":true,"technologies":[{"name":"CAPA","optional":true}],"status":"live","first_seen_at":"2026-09-09T19:15:08Z","employer_posted_date":"2026-10-09","last_verified_at":"2026-10-18T08:19:25Z","board_verified":true,"closed_at":null,"days_open":38,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":38},"description":"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.\nDescription: \nThe 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.\nExperience: \nBS in a scientific discipline\nMinimum 10-12 years’ experience in Quality Assurance in the pharmaceutical industry and 5 years managing personnel\nSignificant expertise with implementation and improvement of enterprise systems: Quality Management Systems, Documentation Systems, and Learning Management Systems\nMinimum 3 years’ experience with Vendor Qualification and Management\nDemonstrated capability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues\nAbility to identify technical problems and suggest resolution of the issues\nStrong collaboration and communication skills\nAbility to manage timelines for oneself and others\nKnowledge of cGMP principles with respect to US, EU, and other relevant regulatory guidance and familiarity with drug development is a plus.\nResponsibilities: \nImprove and streamline existing QMS processes, such as Change Control, Deviations and CAPA Management, Document Management, GxP Training, and Vendor Management\nAssess current state of Quality Systems at Wave and develop a staged plan to arrive at inspection readiness\nDevelop a team of QS personnel fostering a culture of collaboration, continuous improvement and customer service\nOversee the development, maintenance, and optimization of QS policies, procedures, and templates\nEnsure that all QS processes comply with applicable global regulatory requirements (e.g., FDA, EMA, ICH, etc.)\nEstablish and monitor eQMS performance metrics to ensure process effectiveness and compliance.\nLead cross-functional initiatives to identify and implement process improvements.\nFoster a culture of innovation and proactive problem-solving within the QS team\nAct as a liaison between the QS team and other departments to ensure alignment of quality processes with business operations\nCommunicate QS processes strategies, updates, and key metrics to senior leadership and other stakeholders\nLead preparation and response activities for internal and external audits and regulatory inspections\nOther duties as assigned\nKey Skills:\nHands-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 regulations\nDemonstrated ability to coach and develop personnel\nStrong change management skills with a customer service mindset\nExcellent written, verbal and presentation skills for effectively interfacing with collaborators and customers\nAbility to assess and navigate complicated issues, break down the components, and devise practical short-term solutions while formulating long-term fixes\nStrong organizational skills with the ability to effectively multi-task and prioritize\nAbility to adapt to changing business needs and meet timelines within a fast-paced environment\nSelf-motivated with sound judgement and problem-solving skills\nVeeva experience highly desired\nExpertise in CSV principles through implementation of electronic systems desired\nCombination product experience is a plus\nPay Range Disclosure Statement\n$193,000—$261,000 USD\nThe 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.\nWave 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.\nWe 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.\nData Privacy and Your Information\nBy submitting your information in applying for a position at Wave (or lawfully on behalf of a candidate as an approved recruiter), you represent that the information you submit (including your name, phone number, email address, address, and resume/CV/work history) is true and accurate, you have the right to share it, and that no part of the Information violates or infringes the rights of any third parties. If you submit information lawfully on behalf of another applicant as an approved recruiter, you confirm that you have the right to so submit. You grant Wave permission to use your information to contact you in connection with this or another position, for interviews, scheduling purposes, travel arrangements, or follow up after a decision on the role has been made.\nWave Life Sciences is committed to respecting your privacy. We do not sell or rent personal information to third parties for marketing purposes. Any Personal Information you share with us will be used for business purposes, such as communication with you, and handled in accordance with Wave’s Privacy Policy, Notice, Statements, and Additional Information. Wave collects, evaluates and retains candidate data for the legitimate interest of selecting a candidate for employment or contract purposes. Such data will be kept for no longer than necessary to carry out those purposes, unless you consent for your information to be retained up to an additional three (3) years for consideration for future opportunities at Wave. Any requests related to your Personal Information may be electronically submitted to Wave’s Data Protection Officer at https://wavelifesciences.com/privacy/.\nIf you choose to share your demographic background (such as race, gender or sex, national origin, age, disability or veterinary status) by completing the optional survey, your responses will be combined with the answers from other applicants in an aggregated and anonymized form which may be used for equal employment opportunity reporting, diversity and inclusion analysis, and to help us evaluate the effectiveness of our recruiting practices. 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