Tammy Moederzoon
Liberty Hill,TX
Summary
Quality-oriented and detail-driven professional specializing in FDA-regulated drug development within the consulting and contract research organization (CRO) sectors. Proven expertise in sponsor-facing roles, and cross-functional collaborations that prioritize sponsor satisfaction through the timely delivery of high-quality services. In-depth industry knowledge and strong analytical skills enhance overall sponsor and business outcomes, drive continuous process improvements, and cultivate lasting relationships that yield measurable results. Committed to excellence and innovation, consistently striving to exceed expectations in a dynamic regulatory environment.
Overview
2026
2026
years of professional experience
1
1
Certification
Work History
President & Independent Consultant
TDM Quality Consulting, LLC
Liberty Hill, TX
10.2023 - Current
- Perform audits and other consultancy services independently or in collaboration with other consulting firms on behalf of the sponsor, ensuring alignment with their objectives.
- Plans and conducts GLP and GCLP laboratory qualification audits, routine audits, in-process and data audits for testing facilities, central laboratories, bioanalytical, biomarker and other specialty labs.
Consultant, GxP
Advarra Consulting, LLC
Columbia, MD
10.2022 - 10.2023
- Performed independent audits and other consultancy services with a focus of the following regulations/standards: GLP, GCLP, GCP, ISO 13485, and CAP/CLIA
- Planned and performed domestic audits (e.g., investigator site audits (ISA), laboratory audits, facility audits, document audits, etc.) per contractual agreements.
- Planned and performed quality control (QC) of documents and data as requested and assigned for specific projects.
- Conducted internal process/system assessments and standard operating procedure (SOP) gap analyses.
PRN – Consultant Auditor
Worldwide Clinical Trials (WCT)
Austin, TX
02.2016 - 02.2016
- Facilitated seamless transition of quality assurance responsibilities to new manager in collaboration with leadership.
Senior Manager, Quality Assurance
Worldwide Clinical Trials
Austin, TX
06.2013 - 02.2016
- Managed the day-to-day assignment of projects to 4 to 6 Auditors and timelines to ensure customer satisfaction and cross functional department timelines were met.
- Ensured effective management of archives to preserve historical records and support research initiatives.
- Analyzed and compiled monthly metrics for presentation to CEO and upper management, driving continuous improvement initiatives.
- Oversaw the coordination and facilitation of sponsor audits and regulatory inspections. Managed an average of 1-3 sponsor audits each month to ensure compliance and quality standards.
- Developed comprehensive annual risk-based internal audit plans to ensure compliance with 21 CFR Part 58 and 21 CFR Part 11 regulations.
- Supervised the qualification and re-qualification of suppliers and vendors, ensuring alignment with organizational requirements and industry standards.
- Reviewed clinical eCTD study reports from WCT’s Phase 1 Unit in San Antonio, TX, ensuring integration of pharmacokinetic and bioanalytical data.
- Ensured corrective and preventative action plans (CAPA) for internal and external audits were completed.
- Assisted the marketing department with requests for information (RFI).
- Served as Chair of the SOP Committee to ensure standardization of laboratory and quality processes.
Remote Senior Quality Assurance Auditor
Worldwide Clinical Trials
Kingsville, TX
06.2011 - 05.2013
- Conducted audits remotely of bioanalytical method validations, sample analysis data, training records, equipment records, pharmacokinetic/toxicokinetic data, draft/final reports, instrumentation qualifications, and computer software validations.
- Communicated findings to project directors, study directors, and test facility management to support decision-making processes. Collaborated with teams to ensure accurate reporting of study results.
- Oversaw maintenance of accurately indexed quality assurance (QA) records for phase audits and inspections within TrackWise.
- Supported quality assurance manager in conducting supplier and vendor audits and completing questionnaires.
- Provided mentorship to junior auditors, focusing on effective auditing techniques and industry best practices.
Manager, Quality Assurance
Worldwide Clinical Trials (formerly CEDRA Corporation)
Austin, TX
2006 - 06.2011
- Managed the day-to-day assignment of projects to 5 to 7 Auditors and timelines to ensure customer satisfaction and cross functional department timelines were met.
- Supervised archival operations and facilitated archivist in preserving historical documents.
- Ensured compliance with 21 CFR Part 58 regulations, 21 CFR Part 11 regulations and WCT/sponsor SOPs through monitoring, inspecting, and auditing of regulated clinical and non-clinical studies.
- Developed comprehensive annual risk-based internal audit plans to enhance organizational compliance.
- Oversaw the evaluation of suppliers and vendors qualifications to maintain quality and reliability in sourcing.
- Served as a key leader in the implementation of TrackWise for the Quality Management System (QMS).
- Acted as a liaison between the internal staff, site management, sponsors, and FDA inspectors.
- Oversaw the coordination and facilitation of sponsor audits and regulatory inspections. Managed an average of 1-3 sponsor audits each month to ensure compliance and quality standards.
- Reviewed audit reports to identify improvements that enhance the quality and clarity of reports.
Quality Assurance Auditor V
CEDRA Corporation
Austin, TX
01.2005 - 01.2006
- Conducted study specific audits of bioanalytical method validations, sample analysis data, training records, equipment records, pharmacokinetic/toxicokinetic data, draft/final study reports, instrumentation qualifications, and computer software validations.
- Conducted internal audits to assess compliance with quality standards and regulatory requirements.
- Identified issues of non-compliance and elevated reports to senior personnel, project/study directors.
- Maintained properly indexed QA records of phase audits/inspections.
- Assisted in companywide GLP training sessions.
- Oversaw management of the master schedule to ensure optimal resource allocation.
- Facilitated external supplier/vendor assessments by assisting quality assurance manager with audit processes and questionnaire development.
Method Validation Project Director
CEDRA Corporation
Austin, TX
01.2004 - 01.2005
- Directed daily project management for 8-12 clinical and non-clinical bioanalytical LC-MS/MS method validation studies across multiple sponsors.
- Reviewed and interpreted scientific data results
- Coordinated and communicated project status updates, maintaining transparency with sponsors from project initiation to final study report and archiving.
- Analyzed previous data sets to effectively manage and prioritize analysts' daily responsibilities.
- Evaluated project timelines and monitored progress to facilitate on-time delivery of key deliverables.
- Assisted in data review of the stock stability program for reference and internal standards.
- Engaged with method development scientists to troubleshoot and optimize analytical processes.
Quality Assurance Associate Auditor
CEDRA Corporation
Austin, TX
01.2003 - 2004
- Audited and inspected studies to ensure GLP standards were met. This included Analyst’s performance, sample login, sample aliquoting, individual analysis folders, data tables and the final study report.
- Audited equipment maintenance and repair records, logbooks, and training records.
- Scheduled in-process inspections and facility inspections for the QA Unit.
- Performed new employee and annual GLP training.
Project Associate
CEDRA Corporation
Austin, TX
01.2002 - 01.2003
- Primary responsibilities were to assist Project Directors with overall project management including sample accessioning issues, technical review of data and chromatography, Sponsor contact, meetings and minutes, and supervision of Analysts in absence of Project Director.
- Performed Project Director level checks of data tables and solution preparation documentation.
- Maintained detailed documentation of all project phases, ensuring accurate record-keeping and easy retrieval of information when needed.
- Contributed to the development of best practices within the organization, sharing knowledge with colleagues and fostering a culture of continuous improvement.
- Partnered with project team members to identify and quickly address problems.
- Verified quality of deliverables and conformance to specifications before submitting to clients.
Quality Control Auditor III
CEDRA Corporation
Austin, TX
10.1999 - 01.2002
- Conducted meticulous quality control (QC) assessments of data folders, tables, equipment records, and reports to uphold data integrity.
- Analyzed solution preparation documentation and transformed raw data into structured summary tables for comprehensive reporting.
- Collaborated with production teams to identify and resolve quality issues promptly.
- Trained new staff on quality control procedures and best practices.
Analyst II
CEDRA Corporation
Austin, TX
04.1999 - 10.1999
- Analyzed biological fluid samples to determine the levels of pharmaceuticals (small-molecule) and their respective metabolites via liquid-liquid and solid-phase extraction methodologies for bioequivalence (BE), bioavailability (BA), and animal toxicology studies.
- Assisted with sample logins and inventory management. Supported calibration of pipettes. Prepared essential reagents and solutions for extraction processes.
Education
Bachelor of Science - Biology, Minor in Chemistry
Texas State University
San Marcos, TX12-1998
Skills
- Microsoft Office Suite, Watson LIMS, Analyst, TrackWise
- Problem-solving skills
- Analytical thinker
- Attention to detail
- Team leadership & development
- Client relationships
- Strategic planning
- Process improvement
- Project management
- Organizational skills
- Effective time management
- Collaborative team member
Certification
- CITI Program Good Clinical Practice Course, 2022-10-01
- CITI Program Human Subject Course – Basic/Refresher, 2022-10-01
- Society of Quality Assurance, Registered Quality Assurance Professional in Good Laboratory Practices (RQAP-GLP), 2006-01-01, 2016-01-01
- University of Texas at Austin, Continuing Education - Conflict Management, 2006-01-01
- University of Texas at Austin, Continuing Education - Supervising and Managing People, 2006-01-01
- Society of Quality Assurance (SQA) Annual Meeting, 2006-01-01, 2007-01-01, 2008-01-01, 2010-01-01, 2013-01-01, 2014-01-01
- SQA Training - Introduction to the Principles of Computer Validation, 2007-01-01
- SQA Training - Advanced Training Good Laboratory Practice, 2007-01-01
- SQA Training - Bioanalytical Training, 2008-01-01
- SQA Training - Good Clinical Practice: Understanding the Basics, 2010-01-01
Timeline
President & Independent Consultant
TDM Quality Consulting, LLC
10.2023 - Current
Consultant, GxP
Advarra Consulting, LLC
10.2022 - 10.2023
PRN – Consultant Auditor
Worldwide Clinical Trials (WCT)
02.2016 - 02.2016
Senior Manager, Quality Assurance
Worldwide Clinical Trials
06.2013 - 02.2016
Remote Senior Quality Assurance Auditor
Worldwide Clinical Trials
06.2011 - 05.2013
Quality Assurance Auditor V
CEDRA Corporation
01.2005 - 01.2006
Method Validation Project Director
CEDRA Corporation
01.2004 - 01.2005
Quality Assurance Associate Auditor
CEDRA Corporation
01.2003 - 2004
Project Associate
CEDRA Corporation
01.2002 - 01.2003
Quality Control Auditor III
CEDRA Corporation
10.1999 - 01.2002
Analyst II
CEDRA Corporation
04.1999 - 10.1999
Manager, Quality Assurance
Worldwide Clinical Trials (formerly CEDRA Corporation)
2006 - 06.2011
Bachelor of Science - Biology, Minor in Chemistry
Texas State University