Lisa Martin
QA Leader Global Strategy | GCP Compliance Expert | Inspection Readiness | Quality Systems | Risk-Based Oversight | RQAP and CCRP Certifications
- Role
- Senior Director Quality Assurance at Inclin, Inc
- Location
- Tucson, AZ, US
- LinkedIn followers
- 500 followers
About Lisa Martin
I am a Senior GCP QA executive with over 30 years experience in Clinical Research. I still get genuinely excited when a team clicks, a system works, and a trial runs cleanly. I am an expert in building scalable Quality Management Systems, overseeing audit and inspection readiness programs, and implementing risk-based processes and quality management programs. I am a trusted partner to clinical operations and executive leadership, and am known for strengthening compliance while enabling efficient, fit-for-purpose, high-quality trial execution. Building strong QA programs is what I do — but building the people behind them is what I love. I have a consistent track record of creating environments where people understand and grow professionally. The customers, colleagues and students I have mentored over the years are some of my proudest professional accomplishments. I am an elected member of the Society of Quality Assurance (SQA) Education Committee and support the development of high-quality education and training resources within the global GCP QA community.
Experience
Senior Director Quality Assurance
Nov 2022 — Present · San Mateo, CA, US
Head of Internal QA and set CRO-wide global quality strategy and priorities.• Lead inspection readiness, gap assessments and corrective actions.• Direct service provider qualification and ongoing oversight program.• Implement ICH E6(R3) quality framework across SOPs and processes.• Oversee Part 11/Annex 11 system validation and secure e-signature tools.• Ensure eTMF/Veeva QC aligns with DIA standards.• Chair Controlled Document Committee• Member, Data Privacy committees.• Manage, coach, and develop a first-class QA team.• Lead global team to conduct internal, site, and service provider audits; CAPAs management.• Host customer audits and support regulatory inspections.
Education
Park University
MBA, Business Administration and Management, General
2010 — 2013
Park University
BS, Healthcare Administration
2005 — 2007
Northland Career Center
Nursing, Nursing
1992 — 1993
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