Zenith Khan Email & Phone Number | A GXP Quality Systems management professional with over 16 years of experience within the pharmaceutical, combination product, and medical device industry for managing/directing QA activities to support GCP clinical, GLP, GMP, GDP and GVP activities. Strong background in working with FDA-regulated environments, data auditing, supplier (CDMO/CRO) management and clinical study oversight, validated computer systems oversight and GMP process validation, and clinical/commercial drug manufacturing operations. Strong experience in formulating compliance strategies, advice and decision making. Patient-focused, Proactive, assertive, meticulous, objective, highly organized, and a very successful user of influential communication skills. Skills include; • GxP Regulatory Inspection Readiness (PAI inspection, mock inspections) • Establish global QMS, lead quality improvements such as deviations, CAPA/OOS, investigations and implementation validated electronic QMS systems, generate QMS documentation (SOPs, Policies, Work Instructions) • Generate risk-based KPI/metrics reports for Management Review • Review of Clinical Documents (Study/Data/Monitoring Plans, Protocol/Amendments, Informed Consent Forms (general and site specific), Investigator Brochure, Study Report, Data Transfer, etc.) • Review of Clinical Monitoring Report, Source Data Verification, CRO and CRA monitoring oversight (eTMF, SharePoint, Medidata RAVE, IWRS, IRT, E-Diaries, Veeva). • Audit of Investigator Site Audits and eTMF • Review and Reconciliation of AE/PQCs MedWatch Reports • Review of Safety reports (DSUR, PBRER/PSUR, PADER, SUSAR • Review of Computer Systems Validations, Audit Trails, LIMS and Environmental Monitoring System (EMS) Software Design Requirements, Change Controls, Part 11 compliance • Support implementation of Early/Expanded Access Programs (EAP) in US and EU • Review of Manufacturing / Packaging Batch Records, Release Testing/ Laboratory Data, Change Controls, • Establish and Manage GxP Audit/Vendor Qualification Program in USA and EU • Audit of GxP Suppliers (GCP, GMP, GCLP, GVP, GDP) CRO, CDMO, Product/Service Vendors, Specialty Pharmacies • Document Control and Data Archival Management • Data and system audits (PK/TK, Bioanalytical (small molecule), Dose Formulations Analysis, and Immunogenicity (Ligand Binding/ Immunology) Analysis, Quality Control / COA analysis, Equipment/Process Validation and Stability Data)

Zenith Khan

A GXP Quality Systems management professional with over 16 years of experience within the pharmaceut...
San Diego Metropolitan Area, San Diego Metropolitan Area, United States

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Zenith Khan’s Email zkhan@evofem.com

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Zenith Khan’s Location San Diego Metropolitan Area, San Diego Metropolitan Area, United States

Zenith Khan’s Current Industry Qtech Solutions

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Work Experience

Qtech Solutions

President

2024-01-01T00:00:00.000Z - Present

Cti Biopharma

Associate Director Clinical Quality

2023-01-01T00:00:00.000Z - 2024-01-01T00:00:00.000Z

Evofem Biosciences

Associate Director, GxP Compliance

2020-06-01T00:00:00.000Z - 2022-11-01T00:00:00.000Z

Bioagilytix

Manager, Quality Assurance Compliance

2019-07-01T00:00:00.000Z - 2020-06-01T00:00:00.000Z

Microconstants

Supervisor, Quality Assurance Compliance

2016-02-01T00:00:00.000Z - 2019-07-01T00:00:00.000Z

Quidel

Associate Group Process Chemist

2007-01-01T00:00:00.000Z - 2008-05-01T00:00:00.000Z

American Peptide

GMP Analytical Chemist

2006-01-01T00:00:00.000Z - 2006-01-01T00:00:00.000Z

Skills

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Languages

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FAQ About Zenith Khan

Zenith Khan is located at
San Diego Metropolitan Area, San Diego Metropolitan Area, United States

Zenith Khan is a A GXP Quality Systems management professional with over 16 years of experience within the pharmaceutical, combination product, and medical device industry for managing/directing QA activities to support GCP clinical, GLP, GMP, GDP and GVP activities. Strong background in working with FDA-regulated environments, data auditing, supplier (CDMO/CRO) management and clinical study oversight, validated computer systems oversight and GMP process validation, and clinical/commercial drug manufacturing operations. Strong experience in formulating compliance strategies, advice and decision making. Patient-focused, Proactive, assertive, meticulous, objective, highly organized, and a very successful user of influential communication skills. Skills include; • GxP Regulatory Inspection Readiness (PAI inspection, mock inspections) • Establish global QMS, lead quality improvements such as deviations, CAPA/OOS, investigations and implementation validated electronic QMS systems, generate QMS documentation (SOPs, Policies, Work Instructions) • Generate risk-based KPI/metrics reports for Management Review • Review of Clinical Documents (Study/Data/Monitoring Plans, Protocol/Amendments, Informed Consent Forms (general and site specific), Investigator Brochure, Study Report, Data Transfer, etc.) • Review of Clinical Monitoring Report, Source Data Verification, CRO and CRA monitoring oversight (eTMF, SharePoint, Medidata RAVE, IWRS, IRT, E-Diaries, Veeva). • Audit of Investigator Site Audits and eTMF • Review and Reconciliation of AE/PQCs MedWatch Reports • Review of Safety reports (DSUR, PBRER/PSUR, PADER, SUSAR • Review of Computer Systems Validations, Audit Trails, LIMS and Environmental Monitoring System (EMS) Software Design Requirements, Change Controls, Part 11 compliance • Support implementation of Early/Expanded Access Programs (EAP) in US and EU • Review of Manufacturing / Packaging Batch Records, Release Testing/ Laboratory Data, Change Controls, • Establish and Manage GxP Audit/Vendor Qualification Program in USA and EU • Audit of GxP Suppliers (GCP, GMP, GCLP, GVP, GDP) CRO, CDMO, Product/Service Vendors, Specialty Pharmacies • Document Control and Data Archival Management • Data and system audits (PK/TK, Bioanalytical (small molecule), Dose Formulations Analysis, and Immunogenicity (Ligand Binding/ Immunology) Analysis, Quality Control / COA analysis, Equipment/Process Validation and Stability Data)

Zenith Khan currently works in the Qtech Solutions |

No Languages Available

Zenith Khan has prior
experience in the following industries:
Cti Biopharma | Evofem Biosciences | Bioagilytix | Microconstants | Quidel | American Peptide

Zenith Khan has the following professional experience:
Qtech Solutions | Cti Biopharma | Evofem Biosciences | Bioagilytix | Microconstants | Quidel | American Peptide