Karen Zink Mccullough Email & Phone Number | Visionary, patient-focused Quality leader, executive and consultant with extensive experience in the design, development, implementation, maintenance and training in Quality Systems for sustainable compliance in the manufacture, testing and distribution of cell/gene therapies, drugs, biologicals and IVD/medical devices. Consulting history includes interim VP of Quality for a cell/gene CMO, Interim Site Head, Quality Operations (ex-US), cell/gene CMO, assessment and responses to 483, warning letter, consent decrees. Represents clients with BARDA, FDA,and other competent authorities/notified bodies. Lead auditor for Quality Systems assessment and remediation. Recognized national and international subject matter expert in Pharmaceutical Microbiology particularly the Bacterial Endotoxins test. Highly respected nationally and internationally recognized GMP speaker and trainer, with corporate and local presentations/seminars/courses on Bacterial Endotoxin Detection, QC Microbiology, Quality Systems, Auditing, Risk and Microbiology. Elected member, United States Pharmacopeia Expert Committee, General Chapters, Microbiology; US delegate to ISO TC 209, WG02, Revision to ISO 14698, “Biocontamination”; Chairperson and Co-Founder, LAL Users’ Group; Member, Board of Directors, Pharmaceutical Microbiology Forum. Editor of one book, author of 15 book chapters and 12 technical articles.

Karen Zink Mccullough

Visionary, patient-focused Quality leader, executive and consultant with extensive experience in the...
Whitehouse Station, New Jersey, United States

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Karen Zink Mccullough’s Email kmccullough@dendreon.com

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Karen Zink Mccullough’s Location Whitehouse Station, New Jersey, United States

Karen Zink Mccullough’s Current Industry Mmi Associates

Karen Zink Mccullough’s Prior Industry Dendreon | Roche Molecular Systems | Organon

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Managing Member

1985-04-01 00:00:00 - Present

VP Quality Operations

2012-07-01 00:00:00 - 2017-10-01 00:00:00

Sr. Director Quality Compliance

2003-01-01 00:00:00 - 2011-01-01 00:00:00

Director, Microbiology

2002-01-01 00:00:00 - 2003-01-01 00:00:00

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Karen Zink Mccullough is located at
Whitehouse Station, New Jersey, United States

Karen Zink Mccullough is a Visionary, patient-focused Quality leader, executive and consultant with extensive experience in the design, development, implementation, maintenance and training in Quality Systems for sustainable compliance in the manufacture, testing and distribution of cell/gene therapies, drugs, biologicals and IVD/medical devices. Consulting history includes interim VP of Quality for a cell/gene CMO, Interim Site Head, Quality Operations (ex-US), cell/gene CMO, assessment and responses to 483, warning letter, consent decrees. Represents clients with BARDA, FDA,and other competent authorities/notified bodies. Lead auditor for Quality Systems assessment and remediation. Recognized national and international subject matter expert in Pharmaceutical Microbiology particularly the Bacterial Endotoxins test. Highly respected nationally and internationally recognized GMP speaker and trainer, with corporate and local presentations/seminars/courses on Bacterial Endotoxin Detection, QC Microbiology, Quality Systems, Auditing, Risk and Microbiology. Elected member, United States Pharmacopeia Expert Committee, General Chapters, Microbiology; US delegate to ISO TC 209, WG02, Revision to ISO 14698, “Biocontamination”; Chairperson and Co-Founder, LAL Users’ Group; Member, Board of Directors, Pharmaceutical Microbiology Forum. Editor of one book, author of 15 book chapters and 12 technical articles.