William T. Holden

Senior Manager Global Quality Management Systems @Incyte

Newark, DE, US
EMAILS
w••••••@incyte.com
MOBILE NUMBERS
+13•••••••49

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WORK HISTORY

Jun 2022 — Present

Senior Manager Global Quality Management Systems @Incyte

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Wilmington, DE, US

EDUCATION

1990 — 1991

The University of Tennessee Health Science Center

Non Degree, Biochemistry and Molecular Biology

2006 — 2006

UC San Diego

Certificate, Regulatory Affairs

2006 — 2006

Agilent Technologies, Inc.

ISO14971, Risk Management

N/A

UC San Diego

Quality Assurance& Control and Regulatory Affairs

2006 — 2006

Agilent Technologies, Inc.

Greenbelt, Six Sigma

1997 — 1999

University of Memphis

Masters, Instruction and Curriculum Leadership-Education

2005 — 2005

Agilent Technologies, Inc.

ISO13485, Medical Devices

1985 — 1989

Rhodes College

Bachelor, Biology

2005 — 2005

UC San Diego

Certificate, Quality Assurance and Control,

SKILLS

Pharmaceutical QualityIso 13485Quality ControlGmpQuality ManagementRegulatory AffairsLifesciencesBiologics ProductionIsoPharmaceutical IndustrySopFdaBiologics QualitySix SigmaGxpQuality AuditingSupplier Management21 Cfr Part 11Quality SystemV&VMolecular BiologyRoot Cause AnalysisCgmpIso14971Product DevelopmentTechnology TransferIso13485R&DSupplier AuditsMedical DevicesCapaIso 9000Design of ExperimentsManufacturingLife SciencesLimsBiotechnologyResearch and Development (R&D)Good Laboratory Practice (Glp)Glp

ABOUT WILLIAM T. HOLDEN

As a Senior Manager Global Quality Management Systems at Incyte, I lead the quality assurance and compliance activities ensuring the highest standards of quality and safety for pharmaceutical, biologics, and medical device products. I have over 20 years of experience in quality management, quality control, and regulatory affairs, working with global and domestic markets and suppliers, and leading cross-functional teams to solve quality issues and implement quality systems in a variety of both life science, pharmaceutical, and industrial organizations.I hold a certificate in Regulatory Affairs from the University of California, San Diego, and a Greenbelt in Six Sigma from Agilent Technologies, Inc. I am also trained in ISO14971 Risk Assessment, ISO13485 Medical Devices, and cGMP regulations. I have a Master of Science degree in Instruction and Curriculum Leadership-Education from the University of Memphis, and a Bachelors degree in Biology from Rhodes College. My mission is to leverage my operational and technical leadership, biotechnology expertise, and customer interactions skills to deliver quality excellence and innovation for organizations and their stakeholders.

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