Wave Life Sciences
Job 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 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 the Quality Assurance (QA) team, the QA Manager, Vendor QA will lead the vendor management program, internal and some external audits, as well as operational support where needed. This individual will collaborate cross‑functionally with representatives from Supply Chain (SC), Manufacturing, Quality Control (QC), Information Technology (IT) and other teams in support of preclinical, clinical, and commercial product development.
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 7 years of related experience in a Quality Assurance organization, with at least 5 years’ experience in Vendor Qualification
Experience working in a GMP environment in the pharmaceutical or biotechnology industry; GXP experience is a plus
Experience supporting both investigational phase and commercial products is strongly preferred
Demonstrated experience conducting and managing supplier audits and related documentation
Experience conducting internal audits
Responsibilities
Lead the end‑to‑end vendor qualification process, ensuring compliance with regulatory and company standards
Manage the creation and revision of vendor management procedures
Plan and conduct onsite or remote supplier audits
Identify, assess, and mitigate supplier‑related risks
Drive continuous improvement initiatives for the vendor management program
Plan and conduct/support internal audits
Manage quality records related to vendor management in Veeva
Provide guidance to internal stakeholders on vendor management process
Support supplier correction action reports (SCARs) and supplier change notifications (SCNs) processes
Report on KPIs related to Supplier Qualifications and internal audits
Ad-hoc tasks as assigned by manager
Key Skills
Strong understanding of vendor management process
Conducting internal and supplier audits
Problem Solving
Collaboration with suppliers and internal stakeholders
Knowledge of electronic solutions including Veeva, SmartSheets and SharePoint strongly preferred
Ability to work independently
Ability to travel domestically and internationally, up to 25%
Pay Range External Disclosure Statement The annual base salary range for this position is $125,000 – $169,000. 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), 401(k) participation with matching contributions, and an 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.
Seniority level: Mid‑Senior level | Employment type: Full‑time | Job function: Quality Assurance
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As a member of the Quality Assurance (QA) team, the QA Manager, Vendor QA will lead the vendor management program, internal and some external audits, as well as operational support where needed. This individual will collaborate cross‑functionally with representatives from Supply Chain (SC), Manufacturing, Quality Control (QC), Information Technology (IT) and other teams in support of preclinical, clinical, and commercial product development.
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 7 years of related experience in a Quality Assurance organization, with at least 5 years’ experience in Vendor Qualification
Experience working in a GMP environment in the pharmaceutical or biotechnology industry; GXP experience is a plus
Experience supporting both investigational phase and commercial products is strongly preferred
Demonstrated experience conducting and managing supplier audits and related documentation
Experience conducting internal audits
Responsibilities
Lead the end‑to‑end vendor qualification process, ensuring compliance with regulatory and company standards
Manage the creation and revision of vendor management procedures
Plan and conduct onsite or remote supplier audits
Identify, assess, and mitigate supplier‑related risks
Drive continuous improvement initiatives for the vendor management program
Plan and conduct/support internal audits
Manage quality records related to vendor management in Veeva
Provide guidance to internal stakeholders on vendor management process
Support supplier correction action reports (SCARs) and supplier change notifications (SCNs) processes
Report on KPIs related to Supplier Qualifications and internal audits
Ad-hoc tasks as assigned by manager
Key Skills
Strong understanding of vendor management process
Conducting internal and supplier audits
Problem Solving
Collaboration with suppliers and internal stakeholders
Knowledge of electronic solutions including Veeva, SmartSheets and SharePoint strongly preferred
Ability to work independently
Ability to travel domestically and internationally, up to 25%
Pay Range External Disclosure Statement The annual base salary range for this position is $125,000 – $169,000. 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), 401(k) participation with matching contributions, and an 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.
Seniority level: Mid‑Senior level | Employment type: Full‑time | Job function: Quality Assurance
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