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The Sr Quality Operations Leader, Equipment Services will partner internally and globally with internal and external stakeholders to manage a world-class Quality Assurance program to meet key customer expectations and enhance growth in the Equipment Services business.
Job Responsibility
Monitor Quality KPI’s and ensure compliance with quality standards by working collaboratively with the Global Quality Team and Equipment Services
Participate in the Equipment Services Internal Audits program leading internal audits
Support the Deviations and Complaints processes, participating in root cause analysis and developing action plans
Lead monthly CAPA/Change Control review boards, weekly quality reviews and Daily Visual Management
Collaborate cross functionally with the Equipment’s Services focusing on standardization of processes globally and continuous improvement initiatives
Requirements
Bachelor's degree and minimum 5+ years’ work experience in a Quality or Regulatory Assurance related field including but not limited to Biopharma or Life Sciences
Qualified Auditor to ISO9001
Demonstrated experience with data analysis, creating custom reports and/or standardizing reporting across multiple organizations
The ability to identify, prioritize, and solve problems (using DBS tools) is essential
Strong interpersonal skills and ability to communicate complex information effectively (both written and oral)
Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications