Quality Director – Global QMS

Repligen Corporation

full-time

Posted on: 9/1/2025

Location: Massachusetts • 🇺🇸 United States

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About the role

Join Repligen, a life sciences company focused on bioprocessing products, technologies, and solutions for biologic drug production.
Lead development and monitoring of the Global QMS, including business eQMS system as Global QMS system owner.
Lead Global QMS process development, SOP periodic reviews, and continuous improvement.
Oversee development & maintenance of Global QMS training curriculum with senior managers and site QA leaders.
Act as Senior Quality reviewer for procedures supporting Global QMS alongside Sr QA Directors & VP Global Quality.
Act as QMS Coach to site Quality leaders and collaborate on onboarding & annual Global QMS Training modules.
Report on Global QMS performance metrics to senior management and stakeholders and support external audits.
Promote quality education and compliance culture via site Media resources and Repligen Quality Portal.
Support priority Quality tasks or projects assigned by senior management.

Bachelor's Degree in a relevant field such as life sciences, pharmaceuticals or quality management
Minimum of 12 years of experience in quality management in the pharmaceutical/life science industry.
Minimum 5 years people leadership experience
In-depth knowledge of ISO 9001 requirements
Experience of implementing QMS systems and Training programs
Strong leadership and communication skills, with the ability to effectively lead a team and collaborate with cross-functional teams.
Experienced in coaching others and delivering training
Experienced QMS Auditor
Proficiency in Microsoft suite, SAP
Awareness of lean manufacturing principles