Joanne Starkey
Denver,CO
Summary
Dynamic executive leader with extensive experience in laboratory operations and regulatory compliance across HCT/P, pharmaceuticals, medical devices, and sterility testing sectors. Demonstrates a proven ability to lead cross-functional teams towards achieving operational excellence and sustainable business growth. Expertise in navigating FDA regulations and ISO standards while implementing strategic initiatives that promote continuous improvement.
Overview
14
14
years of professional experience
Work History
Regulatory Consultant, Owner
Trail Stone Consulting, LLC
01.2018 - Current
- Provided regulatory guidance and interim leadership for medical device manufacturers
- Led multiple projects on regulatory process optimization and quality assurance
- Performed audits for Central and Reference Laboratories
- Developed strategies to reduce non-compliance risks and implemented corrective measures.
Vice President of Quality (Corporate)
Certified Group
11.2022 - 03.2025
- Company Overview: International CTL
- Led the OTC testing division, elevated QMS and Operations to pharmaceutical-level standards, driving over $500k in growth over target
- Spearheaded the harmonization and integration of 5 acquired facilities into a unified, profitable, and compliant vertical
- Guided the completion of an FDA 483 remediation project, ensuring full regulatory compliance
- Implemented an eQMS to streamline KPI data management, resulting in more efficient trend analysis and reporting to C-suite
- Established global policies to foster a quality-driven culture and continuous improvement
- Developed and executed a Master Validation Plan meeting FDA, ICH, ISO, and Health Canada requirements
Director of Quality
Defender SD Manufacturing
10.2021 - 10.2022
- Company Overview: CMO
- Led the re-launch of an ISO Class 5 cleanroom for sterile pharmaceutical manufacturing post-acquisition
- Addressed FDA 483 findings, preparing the facility for subsequent FDA inspection
- Authored stability study and E&L protocols, ensuring compliance with FDA, USP, and ISO standards for product release
- Oversaw client-facing documentation for NDA/ANDA submissions to the FDA, ensuring regulatory compliance
- Coordinated with various departments to ensure compliance with regulatory requirements related to quality control.
Vice President of Operations / Interim Vice President of Quality
Infinity Laboratories
09.2019 - 09.2021
- Company Overview: National
- Integral to expanding the company from 2 to 10 sites, driving revenue growth from $2M to over $30M
- Led the integration of acquired sites, aligning them with global performance standards
- Optimized Quality Event Management system, reducing TAT from 30+ days to under 7 days
- Prepared financial analyses and cost-saving strategies, saving the company $250k by correcting a prior project proposal
- Lead initiatives aimed at improving customer service levels through process optimization.
Acting Director of Operations
VRL-Eurofins Laboratories
Centennial, USA
01.2017 - 01.2018
- Streamlined operations in a high-throughput infectious disease testing lab to meet regulatory and production standards for HCT/P manufacturers and OPOs
- Managed a team of over 30 reports (managerial and tech level) to ensure compliance and production targets were met
- Provided subject matter expertise in 21 CFR 1271 and cGLP/GTP for internal and external stakeholders
- Provided leadership and guidance to subordinate managers and supervisors.
- Ensured compliance with applicable laws, regulations, industry standards.
Quality Assurance Manager
VRL-Eurofins Laboratories
Centennial, USA
11.2010 - 01.2017
- Led the implementation of a new laboratory, achieving profitability within the first two years
- Developed scalable Quality Management Systems including training, CAPA, Document Control, Nonconformance and Deviations, to align with company growth
- Directed method validation and equipment implementation for satellite labs across the U.S
- Documented all findings from internal audits and external investigations into non-conformances in order to track progress towards resolution.
- Coordinated with operations and logistics teams to integrate quality assurance measures into all phases of process lifecycle.
- Established quality metrics and benchmarks to measure performance and guide strategic decision-making.
Education
Bachelor of Science - Human Biology, Biochemistry
University of Northern Colorado
Greeley, COSkills
- FDA 21 CFR
- ISO 13485
- ISO 14644
- ISO 17025
- ICH
- EU MDR 2017/745
- CLIA
- UNOS
- TJC
- DEA
- QMS Design & Harmonization
- Validation
- Verification
- CAPA and RCA
- Nonconformances
- Deviations
- OOS
- OOT
- FMEA
- LIMS Implementation
- Operational & Quality Systems Optimization
- Executive Leadership
- Team Management
- Budget Management
- Client Relationship Management
- Technical Writing
- Design of Experiments
- Process Optimization
- Project Management
Publications
- Fatal Atypical O:3 Yersinia pseudotuberculosis Infection in Cynomolgus Macaques, Chih-Ling Zao, 2013
- A Novel Simian Retrovirus Subtype Discovered in Cynomolgus Monkeys, Chih-Ling Zao, 2016
References
Available upon request.
Certifications Professional Development
Certified Manager of Quality/Organizational Excellence (CMQ/OE), ASQ, 11/01/22
Core Competencies
FDA 21 CFR, ISO 13485, ISO 14644, ISO 17025, ICH, EU MDR 2017/745, CLIA, UNOS, TJC, DEA, QMS Design & Harmonization, Validation/Verification, CAPA, Nonconformances/Deviations/OOS/OOT, FMEA, DOE, LIMS Implementation, Operational & Quality Systems Optimization, Executive Leadership, Team Management, Budget Management, Client Relationship Management, Technical Writing, Design of Experiments (DOE), Process Optimization, Project Management
Timeline
Vice President of Quality (Corporate)
Certified Group
11.2022 - 03.2025
Director of Quality
Defender SD Manufacturing
10.2021 - 10.2022
Vice President of Operations / Interim Vice President of Quality
Infinity Laboratories
09.2019 - 09.2021
Regulatory Consultant, Owner
Trail Stone Consulting, LLC
01.2018 - Current
Acting Director of Operations
VRL-Eurofins Laboratories
01.2017 - 01.2018
Quality Assurance Manager
VRL-Eurofins Laboratories
11.2010 - 01.2017
Bachelor of Science - Human Biology, Biochemistry
University of Northern Colorado
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