Responsible and accountable for the development and maintenance of global Contract Logistics Pharma & Healthcare Quality Management Systems (QMS) including supervisory development, maintenance, and continued improvements driven through the adherence to company policies, client procedures and applicable regulatory requirements including but limited to GMP, GSP, GDP, EU, WHO, ISO9001/13485. Support locations with the execution and support of internal, client and regulatory inspections. Develop and maintain robust training program, detailed deviation/investigation/change control programs, metrics and Quality Review Boards. Proactively communicate interdepartmentally as well as is with required stakeholders to assure quality concerns, improvement plans and quality agreements are developed and managed in a complaint and timely manner.

Provide comprehensive and advanced knowledge of auditing principles. Execute highly complex or specialized audits supporting global manufacturing, testing, and distribution of clinical and commercial products.

Directs the site internal audit program to verify compliance with global Good Manufacturing Practices regulations, and corporate requirements. Ensures appropriate corrective and preventative actions are taken when required. Assures tracking of corrective action commitments to completion and follow-up to assure sustained, effective implementation. Responsible to lead the preparation, management of external audits and inspections. Works directly with regulatory investigators.• Hosted internal corporate and external agency inspections. Work with Quality and Site Leadership to ensure the site is inspection ready with no lead time.• Reviewed documents and provides input, coaching and feedback to promote continuous improvement.• Assures communication of compliance concerns, regulatory agency inspections and industry trends as part of on-going education and training for GMP compliance.• Worked closely with functional areas (i.e. Manufacturing, QC, etc.) to ensure GMP compliance. • Acts as internal consultant and provides resources with expertise. Assists in compliant investigations. • Assures tracking of key performance metrics and provides input to periodic reviews of effectiveness of the Quality Management System. • Develop and execute QA objectives to align with business plan goals and improvement initiatives. • Participate in developing global policies and procedures. Establish a process to ensure functional site procedures are in compliance with global policies.

Lead a team of auditors responsible for the planning and execution of all the external audits such as Contract Manufacturers, API Suppliers, Excipient Suppliers, Primary and secondary packaging components, printed materials, warehouses, around the globe.• Planned and conducted internal audits of manufacturing, packaging, and testing supporting clinical and commercial pharmaceuticals, biologics, medical devices, and combination products.• Created an external audit program and executing with appropriate procedures and reports in compliance with changing global regulatory requirements.• Managed ten (10) direct reports including personnel located at international locations and responsible for the administration of their job functions.• Support the completion of special departmental goals and tasks as assigned.• Assist in the Supplier and Material Management program related to the scoring and quality/compliance oversight of material and service providers.• Reported high-level metrics to management.