Phillip Strickland

About Phillip Strickland

Strategic and tech-forward Quality Assurance leader with 26+ years of experience building modern, harmonized GxP Quality Management Systems across clinical, laboratory, and technology-driven organizations. Deep expertise in GCP, CSV, data integrity, and risk-based quality governance, with a strong track record of leading cross-functional teams, scaling QMS infrastructures, and delivering inspection-ready environments.At TD2, led enterprise-wide quality transformation initiatives, including establishing and chairing our Systems Governance Committee, implementing risk-based CSV methodologies aligned with GAMP 5, and integrating a newly acquired GLP laboratory into the corporate QMS. Strengthened inspection readiness by leading a company-wide Mock FDA Inspection and supporting multiple successful Sponsor and Site FDA inspections with no findings.Passionate about leveraging technology, automation, and data-driven quality approaches to accelerate drug development. Adept at building quality organizations, partnering with senior leadership, and implementing scalable processes that improve operational efficiency and regulatory compliance.Open to senior leadership roles in innovative biotech and AI-enabled drug development teams, particularly those focused on modernizing GxP operations and digital quality systems.

Experience

1. Director of Quality Assurance

   TD2 Oncology

   Jun 2022 — Present

   Lead enterprise-wide Quality Assurance and GxP compliance for an oncology-focused CRO, overseeing the development and optimization of a harmonized Quality Management System across clinical, laboratory, and technology functions. Drive continuous improvement, inspection readiness, and cross-functional collaboration to support organizational growth and regulatory alignment.Established and chair TD2’s Systems Governance Committee, creating the governance structure, SOPs, and risk-based review process for all electronic systems. Implement a scalable, risk-based framework for system classification, data integrity controls, and CSV requirements. Led foundational GLP integration following acquisition of a regulated laboratory, including onboarding GLP requirements and incorporating the lab’s SOPs and controlled documents into the corporate QMS to strengthen cross-GxP consistency. Direct inspection readiness efforts, including leading a company-wide Mock FDA Inspection and supporting multiple Sponsor and Site FDA inspections that concluded with no findings. Conduct internal audits, vendor audits, and ongoing compliance activities aligned with ICH GCP, GLP, 21 CFR Part 11, and data integrity principles.Administer ZenQMS and drive improvements in CAPA, Deviations, Change Control, Document Control, Training, and Supplier Management. Partner closely with Clinical Operations, Data Management, IT, Laboratory Operations, and executive leadership to embed quality into the full development lifecycle and support scalable, efficient, inspection-ready operations.

Education

• North Carolina Wesleyan University

  B.S., Accounting

  1997 — 1999

• Liberty University

  Master of Science - MS, Homeland Security and Disaster Management

• Nova Southeastern University

  M.S., Management Information Systems

  2001 — 2004

• North Carolina Wesleyan University

  B.S., Computer Information Systems

  1997 — 1999