Senior Director, Global Compliance & Validation Strategy

Donald James Willis Jr

*** * ***** *** **********, DE 19709 • **********@***.*** • 302-***-****

SUMMARY

Senior Director with 20+ years of experience in Global Compliance, Validation, and Quality Assurance across Pharma/Biopharma and Life Sciences industries. Expert in 21 CFR Parts 11/210/211/58/820, ISPE GAMP 5, Data Integrity (ALCOA+), and Quality Systems (ISO 9001, 13485, 17025). Proven record driving NPI commercialization, compliance services marketing, and regulatory alignment initiatives for global organizations.

CORE COMPETENCIES

Computerized System Validation (CSV), CAPA / Quality Systems, Data Integrity & Compliance (ALCOA+), USP <1058> AIQ, USP/EP/JP/ICH, Risk Assessment / Gap Analysis, Product & Service Marketing, FDA / ISO Regulatory Compliance, NPI Development & Commercialization, Project & Program Management

PROFESSIONAL EXPERIENCE

Agilent Technologies – Wilmington, DE

Director, Global Compliance Services Marketing 2016 – 2025

Directed global strategy and P&L growth for $150M compliance services portfolio (10% YoY growth).

Led NPI commercialization, marketing campaigns, and demand generation initiatives.

Developed Sales & Marketing collateral and trained Sales/Service teams to drive enablement and quality.

Oversaw Data Integrity initiatives and ACE (Automated Compliance Engine) deployment for USP 1058 compliance.

Managed CSV and Compliance Consulting services (ISPE GAMP 5).

PerkinElmer – Shelton, CT

Director, Global Validation & Compliance Services 2008 – 2016

Member of global leadership team overseeing asset management and validation programs.

Led Business Development, RFP generation, and portfolio expansion.

Managed teams of 20+ delivering PM/IQ/OQ/PQ qualifications and paperless validation solutions.

Ensured FDA/ISO/USP regulatory compliance across global operations.

Thermo Fisher Scientific – Waltham, MA

Sr. Compliance Services Manager 2003 – 2008

Led multi-vendor services and metrology programs across regulated laboratories.

Directed 15 direct reports and implemented electronic document control (21 CFR Part 11).

Investigated CAPA, deviations, and customer complaints per GxP and QSR requirements.

Rodel, Inc. (Rohm & Haas / Dow Chemical) – Newark, DE

Manufacturing Process Engineer 1996 – 1998

Developed SOPs and achieved ISO 9001 certification.

Applied SPC and DOE to reduce cycle time and increase yield.

Researched and qualified new materials to improve manufacturing processes.

EDUCATION

University of Delaware

Bachelors, Chemistry – 1995

Bachelors, Biology – 1996

TECHNICAL SKILLS

SAP • LIMS • Documentum • CDS • ELN • SDMS • Statistical Process Control (SPC) • Design of Experiments (DOE)

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