Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Steven Kuchenbrod

Elizabeth,IN

Summary

Quality Assurance leader with extensive experience in mitigating compliance risks in the pharmaceutical and biotech sectors. Proven track record in establishing Quality Management Systems and leading compliance programs, enhancing team performance, and ensuring regulatory readiness. Expertise in auditing and strategic planning, driving successful outcomes in clinical trials and product approvals.

Overview

25
25
years of professional experience
1
1
Certification

Work History

Owner/Principal Consultant, R&D Quality Assurance

TrekClinical
06.2023 - Current
  • Evaluation and implementation of Quality Management Systems
  • Audits of Pre-clinical and Clinical Vendors and Laboratories
  • Write and update Standard Operating Procedures
  • Company trainings on GXP Annual Training, Good Documentation Practice, The ICH-GCP E6 R3 Update, and Inspection Readiness

Head, R&D Quality Assurance

Clover Biopharmaceuticals
11.2020 - 04.2023
  • Set up the initial Quality Management System
  • Implemented the Clinical suite of SOPs
  • Managed and trained QA staff in China, Romania, Brazil, and the US
  • Managed the Compliance program, leading to vaccine candidate approval by the Chinese Health Authority.

Owner/Principal Consultant R&D Quality Assurance

TrekClinical
10.2019 - 11.2020
  • GCP Auditor and Compliance for Sponsor Organization
  • Set up of the Quality Management System for Tobacco/Vape companies conducting Clinical Trials under ICH-GCP
  • Wrote SOPs to comply with the updated ICH-GCP E6, R2 revision
  • Trained operational teams on various QA topics
  • Three programs overseen, for QA and Compliance, received commercial approval.

Head, Quality Assurance

Aptinyx
03.2018 - 10.2019
  • Head of QA, over GMP, GLP, GCLP, and GCP
  • Responsible for the update and maintenance of the Quality Management System
  • Updated Clinical SOPs to comply with the requirements of registration trials
  • Conducted audits and trained QA staff

Director, Clinical Compound Support QA

Takeda Pharmaceuticals
12.2014 - 08.2017
  • Compliance oversight for the Dengue vaccine program
  • Internal Audits, Vendor Audits, Investigator Site Audits, Investigations, and Consultant Management
  • Writing and updates to SOPs

Associate Director, Clinical Quality Assurance

Boehringer Ingelheim Pharmaceuticals
09.2009 - 12.2014
  • Conducted routine and for-cause audits for Vendors and Investigator Sites
  • Updated SOPs
  • CSV SME for TrackWise
  • Front room inspection support for 12 FDA inspections
  • Compliance management for Pradaxa program
  • Oversight of Consultant Auditors
  • Built the Global Document Specialist group
  • Revamped the Financial Disclosure program
  • Participated in the first joint FDA/EMA inspection

Manager II, Clinical Quality Assurance

Kendle International
05.2006 - 09.2009
  • Management of global auditors
  • Host of Sponsor Audits
  • Audits of Internal Systems, CSV, Vendor, and Investigator Site Audits
  • Trainer and mentor
  • Update of SOPs
  • Participated in Bid Defense Meetings
  • Conducted For-cause audits

Specialist, Corporate IT Auditing

Abbott Laboratories
07.2000 - 05.2006
  • Completed internal and vendor audits of computerized system validation packages
  • Wrote SOPs
  • Coordinated the training and collection of CAPA and training records
  • Three years working in a commercial bioanalytical laboratory
  • One year as Pre-clinical Study Coordinator for a medical device product.

Education

Healthcare Management

Southern Illinois University, Carbondale
Carbondale, IL
12-2001

Skills

  • Pharmaceutical and Biotech Quality Assurance experience from Pre-clinical, Clinical to Commercialization preparation
  • Team leadership & development
  • Client relationships
  • Analytical thinking
  • Strategic planning
  • Issue resolution
  • Auditing experience with Bioanalytical Laboratories, CROs, Vendors, Investigator Sites, Computer System Validation, and Pharmacovigilance
  • Quality Management Systems
  • Regulatory Inspections
  • Experience with Cardiovascular, Oncology, Metabolic Disease, Dermatology, Women's Health Infectious Disease, Pain, Neuropsychiatry, and Vaccines

Certification

  • RQAP-GCP, Society of Quality Assurance
  • ASQ-CQA, American Society of Quality (Past Certification)

Timeline

Owner/Principal Consultant, R&D Quality Assurance

TrekClinical
06.2023 - Current

Head, R&D Quality Assurance

Clover Biopharmaceuticals
11.2020 - 04.2023

Owner/Principal Consultant R&D Quality Assurance

TrekClinical
10.2019 - 11.2020

Head, Quality Assurance

Aptinyx
03.2018 - 10.2019

Director, Clinical Compound Support QA

Takeda Pharmaceuticals
12.2014 - 08.2017

Associate Director, Clinical Quality Assurance

Boehringer Ingelheim Pharmaceuticals
09.2009 - 12.2014

Manager II, Clinical Quality Assurance

Kendle International
05.2006 - 09.2009

Specialist, Corporate IT Auditing

Abbott Laboratories
07.2000 - 05.2006

Healthcare Management

Southern Illinois University, Carbondale

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