Support the Material Qualification processes including
migration of site-based processes to the global process.
Support management of Quality Agreements.
Support Supplier Change Notification process to ensure
appropriate change control and regulatory updates have been made prior to
Gather data and report quality metrics for internal
processes and identify and implement improvement opportunities.
Perform all responsibilities in accordance with company
policies, procedures, federal regulations and safety requirements.
Minimum of 4+ years' experience in Quality with GMP
pharmaceutical, or biologics experience Experience in Material Qualification,
Procurement, Quality Assurance, or Auditing Experience with Quality Risk
Management and Structured Problem-Solving tools A strong customer focus and
ability to prioritize and adapt to business needs Knowledge of applicable international
GXP regulations and standards Strong business partner with a focus on
Excellent written and verbal communication skills Strong
ability to analyze systems, data Capable of identifying and mitigating risks
Experience with high performance teams, cross functional projects.
Experience with Technical Writing
Experience working with mature supplier quality system
Previous global Quality System development/deployment experience Experience
supporting regulatory inspections