Repligen Corporation

Quality Director – Global QMS

Repligen Corporation

full-time

Posted on:

Origin:  • 🇺🇸 United States • Massachusetts

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Job Level

Lead

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.

Requirements

  • 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