Director Global Quality Supplier Quality Management

Director - Global Quality Auditing And Supplier Management

The Director will report to the Animal Health Global Quality Lead for Compliance and Technical Support and will direct the below aspects of the Supplier Quality Management (SQM) and Animal Health global auditing program :

Responsibilities :

• Perform comprehensive and detailed GMP compliance audits of animal health sites, contractors, business partners, and suppliers, requiring approximately 50% worldwide travel.
• Develop and maintain Technical Quality Agreements.
• Design and build Business Continuity Process and Quality Risk Assessment Module in Reliance.
• Implement standard Supplier Qualification process across sites.
• Implement efficiency and productivity improvements in the Supplier Audit Program, including qualifying additional external audit sources / resources.
• Support Supplier Transparency Data Remediation.
• Support new business opportunities through due diligence, pre-contract, and Pre-PAI audits.
• Accept audit assignments, perform audit pre-work, conduct audits, and write audit reports within defined timeframes.
• Maintain an understanding of our company policies, procedures, and guidelines.
• Stay aware of evolving industry and regulatory trends / regulations.
• Obtain and maintain auditor qualification through ongoing training and continuing education programs.
• Coordinate with Site Quality leads on audit refusals and postponements.
• Lead project initiatives to maintain the effectiveness and efficiency of the audit program.
• Negotiate with external firms to attain acceptable corrective actions and independently generate extensive, high-quality GMP documentation.
• Maintain broad-based expertise in cGMPs, our company Policies, Procedures, and Guidelines, and regulatory requirements pertinent to the pharmaceutical industry.
• Lead and coordinate with Procurement and impacted Site Quality leads on critical audit findings or audit refusals.
• Generate comprehensive presentations / summary of issues for effective communication to all levels.
• Provide support and administrative functions for the electronic Supplier Tracking and Repository System and assist in data maintenance.
• Lead a team of 8-10 who oversee both internal and external auditing and Animal Health Supplier Quality Management.

Required Qualifications :

Preferred :

Required Skills : Audit Readiness, Drug Product Manufacturing, FDA Compliance, FDA GMP, FDA Inspections, FDA Regulatory Requirements, Inspection Readiness, Pharmaceutical Development, Pharmaceutical Industry

Preferred Skills :