QA Manager, Vendor QA

Wave Life Sciences • Lexington, MA

18h • $125,000 - $169,000 • Onsite

About The Position

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 the Quality Assurance (QA) team, the Quality Assurance (QA) Manager, Vendor QA will lead the vendor management program, internal and some external audits, as well as some 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.

Requirements

• 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
• 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%

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
• Adhoc tasks as assigned by manager

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 251-500 employees