Senior Manager, Quality Audits

Responsibilities

• Prepare and execute internal self‑inspections and supplier audits and issue reports.
• Follow up on post audit action tracking & progress.
• Assist in implementing Internal Audit plans for all Grifols manufacturing plants within North America.
• Assist in implementing Supplier Audit plans for all Grifols manufacturing plants within North America.
• Trend, analyze, and report on quality data to improve product and process quality for all Grifols plants; develop actions for improvement based on data analyses.
• Peer‑review and approve audit reports.
• Provide support prior, during and post inspections for External Regulatory Inspections, Customer Audits and Corporate Internal Audits.
• Ensure that findings, risks and improvements are promptly and thoroughly incorporated into the quality systems.
• Keep abreast of industry standards and regulations.
• Contribute to continuous improvement of the Quality Management System.

• Minimum Bachelor’s degree in a scientific discipline.
• Minimum of 8+ years related pharmaceutical experience, preferably in manufacturing, quality assurance, or GMP auditing.
• ASQ Certification as a Quality Auditor, Manager or Engineer is a plus.
• Superior knowledge of U.S. cGMPs and FDA guidance.
• Superior knowledge of EU GMPs, Annexes and ICH Guidance’ and International Standards (Risk Management, ICH 8, 9, 10).
• Knowledge of drug product manufacturing, packaging, laboratory, and warehousing operations.