PTS Advance is looking to speak with Supplier Quality Auditors to join our client who is an established and world-leading pharmaceutical and medical device contract manufacturer in the greater Kansas City, KS area.

In this role, you will oversee the compliance of supplier-related products and services. This position ensures Suppliers meet the company's pharmaceutical requirements and U.S. FDA, Health Canada, ISO and USP, ICH, PDA, and PIC/S standards. Certified Quality Auditor certification is mandatory.

Main Responsibilities

• Leads the development of a strong partnership with the company's Manufacturing Operations, Quality Assurance, and external suppliers, such as API, excipient, container/closure, packaging, and labeling suppliers and contract testing laboratories and contractors and consultants.
• Represents the company as the Subject Matter Expert for pharmaceutical supplier quality during regulatory inspections, submissions, and assessments.
• Serves as the Quality Authority for the selection, development, and approval of new suppliers for new product introductions and assures that strategic initiatives are met.
• Executes and manages Supplier Quality Agreements and amends as needed.
• Manages the Approved Supplier List.
• Manages supplier investigations, CAPAs, complaints, and risk mitigations for commodities that do not meet company specifications.
• Compiles and assesses supplier metrics (Scorecards) for inclusion in the site and company-wide management review meetings.
• Conducts internal audits and maintains the auditor training program.

Required Qualifications

• Bachelor's Degree from an accredited college or university is required.
• 5 years of experience in Pharmaceutical Quality, Manufacturing, Engineering, or R&D functions or any combination thereof, with at least 3 years as a supervisor or manager (preferred).
• Certified Quality Auditor certification is required.
• Direct experience managing external suppliers and third-party manufacturers.
• Prior experience with compliance assessments/audit processes.
• Knowledge of global cGMP regulations; 21 CFR Parts 210, 211, ISO 9001, ISO 13485, ICH, IPEC Guidelines.
• Thorough understanding of Quality Management Systems (Validation, Change Management).
• Understanding of investigational techniques including problem-solving methodology (5 Whys, Ishikawa diagram, DMAIC, etc.).
• Must have proven experience with computer software applications to track and trend quality metrics.

If you or someone you know may be interested, please send your resume to Lisa.Oster@PTSadvance.com or visit us at jobs.PTSadvance.com to learn more about the role. #LifeSciences #PTSAdvancejobs #PTSAdvance