Distribution Supervisor Supply Chain

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PROFILE

Accomplished supply chain quality assurance (QA) executive with a history of boosting company profitability, product quality and reputation with QA solutions. Versatile leader with deep expertise in all aspects of QA, including policy/procedure creation, inspections/audits, regulatory compliance, risk mitigation, product safety and QA technology. Proactive professional who creates and reinforces a “culture of quality” through collaborative partnerships (customers, suppliers, supply chain leaders), extensive training/coaching, KPI tracking and incentives. Relationship builder who serves as a trusted advisor to executive teams, influences at all organizational levels and expertly manages global regulatory agencies. Leader of large teams who hires exceptional talent, develops employee capabilities and advances careers.

STRENGTHS

Strategy & Execution

Regulatory Compliance

Internal/External Audits

Policy/Procedure

Team Leadership

QA Training/Culture

Quality KPIs

Partnerships

QA Software

PROFESSIONAL EXPERIENCE

Crates Consulting Business

CEVA – WMS Validation Project, FDA review of customer proposals, SOP development, Healthcare Culture

Vice President, Quality & Regulatory Affairs

Cardinal Health / Dublin, OH / 2015 - 2020

Promoted to drive a cost-effective and compliant end-to-end global supply chain in the wake of several multibillion-dollar acquisitions (manufacturing companies). Collaborated with the executive team to set strategies that created, implemented and reinforced consistent quality standards – that ensured product integrity and regulatory compliance - across an 80-location global supply chain. Also managed compliance for 5 3rd-party logistics companies that shipped 2B+ pounds of drugs and medical devices. Hired, developed and motivated a team of 130 quality assurance (QA) professionals who executed QMS strategy for product lines that were delivered to labs, hospitals, pharmacies and patients (direct). Completed over 800 regulatory inspections for the FDA, Health Canada, DOT/FAA, Canada Dangerous Goods and Boards of Pharmacy. Instituted game-changing programs/technologies, such as product handling standards, a global hazardous material distribution structure and a Recall Management System.

Implemented first-in-kind product handling standards that slashed damaged and expired product costs by ~$8M annually.

Successfully procured and managed over 6000 regulatory licenses, permits and associated accreditations (e.g. FDA establishment permits, U.S. state licenses, Medicare CHAP and Joint Commission & Pharmacy URAC).

Saved 3PL and other customers $2M annually by managing their recall management licenses and accreditations.

Reduced expenses by $3M by influencing legislatures, regulatory boards and state government agencies to eliminate inefficient regulatory requirements.

Director, Quality Management

Cardinal Health / Dublin, OH / 2008 - 2015

Recruited internally to lead quality management activities for Cardinal Health’s Medical Segment supply chain, which included 55 distribution centers and 3rd-party logistics providers. Integral part of due diligence/integration efforts and establishing quality standards for several large acquisitions. Hired, trained and retained a team of 30 QA leaders and professionals. Managed 300 regulatory inspections.

Director, Quality Management

Cardinal Health / / 1999 – 2011

Managed 13 facilities for regulatory compliance

Quality Manager

Cardinal Health (formerly Allegiance Healthcare) / Memphis, TN / 1996 - 1999

Distribution Supervisor

American Hospital Supply / New Orleans, LA / 1978 - 1996

EDUCATION & CERTIFICATIONS

Bachelor of Arts, History

University of New Orleans

PROFESSIONAL INVOLVEMENT

Nominated by two Governors to serve as Vice Chair, Regulation and Chair, Regulation for State of Louisiana’s Board of Wholesale Drug Distributors.

Listed by the State of Louisiana as a U.S. state regulatory expert in drug/device distribution and pedigree.

Court appointed expert, U.S. state regulation

WILLIAM CRATES

GLOBAL SUPPLY CHAIN QUALITY ASSURANCE EXECUTIVE

Phone: 614-***-****

LinkedIn: www.linkedin.com/in/williamcrates1

Email: *******@***.***

Home : Columbus, OH

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