Valerie C Childress
Castle Rock,CO
Summary
Mission driven Quality Assurance Leader with 20+ years in healthcare and 10+ years directing Quality Management Systems and training programs. Proven ability to lead teams, ensure regulatory compliance (FDA, ISO 13485, CAP, CLIA), and drive process improvement through data-driven strategies. Excellent communicator passionate about fostering a culture of collaboration and engagement while enhancing quality outcomes and organizational efficiency.
Overview
25
25
years of professional experience
1
1
Certification
Work History
Quality Assurance Manager
Doheny Eye Institute
10.2024 - 07.2025
- Led performance reporting for enterprise-wide operations, improving executive visibility and decision-making.
- Mitigated quality risks through change management reviews; ensured accuracy of technical documentation.
- Managed Change Control, Document and Learning Management Systems, supporting compliance and operational efficiency.
- Directed recruitment, coaching, and performance reviews for QA/QC teams.
- Coordinated cross-functional project resourcing and study assignments.
Quality Systems Supervisor
AlloSource
03.2020 - 07.2024
- Defined and implemented Quality system setup requirements.
- Developed and maintained quality systems for training compliance and document control, achieving 100% audit readiness over 8 consecutive inspections.
- Managed and monitored 500+ employee training metrics as part of a compliance improvement strategy, achieving 97% training completion rate.
- Provided QMS system training (SmartSolve) to end users across all levels, increasing adoption and reducing support requests.
Senior Quality System Specialist
AlloSource
06.2016 - 03.2020
- Optimized, managed, and maintained all aspects of the document control process within the QMS (SmartSolve).
- Verified accuracy of document training certification information and training role requirements.
- Compiled/analyzed data presented at quarterly management review meetings.
Regulatory Document Specialist
AlloSource
01.2012 - 06.2016
- Served as lead administrator for the LMS and DMS, ensuring full compliance with organizational and regulatory standards.
- Reviewed and approved controlled documents for accuracy in formatting, grammar, and compliance across 120+ submissions monthly.
- Liaised with cross-functional teams to resolve documentation issues, improve turnaround time, and streamline approvals.
Supply Chain Production Control Review Trainer
AlloSource
06.2007 - 02.2012
- Served as the department trainer and subject matter expert in the Production Control Review process.
- Led small group and individual training sessions based on learning needs.
Production Control Reviewer: Levels 1, 2 & 3
AlloSource
10.2001 - 06.2007
- Performed quality documentation reviews on donor processing records/lab results.
- Corresponded professionally with laboratory contacts.
Database Specialist
AlloSource
10.2000 - 10.2001
- Administered the initial steps required for production input into the database system.
Education
General Studies
Arapahoe Community College
Littleton, CO01.2002
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American Association of Tissue Banks (AATB)
01.2000
Skills
- QMS: IQVIA SmartSolve, Veeva, Cornerstone - FDA, ISO 13485
- Regulatory Compliance & Audit Readiness
- Data-Driven Decision Making
- Training & Development Strategy
- Document Control & Change Management
- Team Leadership & Coaching
Certification
QMS Fusion Conference, IQVIA SmartSolve, 2014 & 2016
COMPLETED COURSEWORK
Coursework: QMS Administration, Auditing, Technical Writing, Leadership, Training & Development, Change Management, System Validation and Configuration
Timeline
Quality Assurance Manager
Doheny Eye Institute
10.2024 - 07.2025
Quality Systems Supervisor
AlloSource
03.2020 - 07.2024
Senior Quality System Specialist
AlloSource
06.2016 - 03.2020
Regulatory Document Specialist
AlloSource
01.2012 - 06.2016
Supply Chain Production Control Review Trainer
AlloSource
06.2007 - 02.2012
Production Control Reviewer: Levels 1, 2 & 3
AlloSource
10.2001 - 06.2007
Database Specialist
AlloSource
10.2000 - 10.2001
General Studies
Arapahoe Community College
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American Association of Tissue Banks (AATB)
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