Manager - Quality Audit

Job Description
* Completes onsite supplier audits for Drug and Biologics team
* Requires up to 35% travel, including international locations
* Identifies Baxter supplier compliance issues; helps to resolve issues in a timely manner
* Partners with facilities, divisions, and regions to ensure successful implementation and compliance to CQP / regulations
* Own and resolve supplier related CAPA(s)
* Analyzes supplier related defect data to determine root cause
* Partners with Global Purchasing to right size the supplier base and continuously improve supplier relationships
* Development and implementation of procedures affecting several business groups and functions
* Understands and assures conformance to regulations for Drug and Biologic suppliers
* May interface with regulators during regulatory inspections
* Participates in or manages quality assessments of internal operations and suppliers to analyze compliance and assess risk
* Interacts frequently with subordinate supervisors and functional peer group managers
* Identifies and manages continuous improvement projects with the objective of achieving quality, reliability and cost improvements.
* Utilizes the Global Supplier Quality Trackwise System (GSQTS) for maintaining Supplier Quality Records

Requirements
* Bachelors Degree in Chemistry, Biology, or life science discipline
* Drug or Biologic manufacturing / operations experience highly preferred
* API auditing experience strongly desired
* Strong technical writing skills
* Ability to clearly document audit findings within audit reports
* Experience in launching new medical products
* Ability to respond to customers (Internal and External) in a timely manner
* Ability to build relationships across functional boundaries at multiple levels internally and externally
* Actively demonstrates Baxter's leadership expectations

To find out more about Real Staffing please visit www.realstaffing.com