Open to opportunities

Ronnie Williams

@ronniewilliams

Message

I’m a senior pharmaceutical quality control coordinator eager to drive data integrity and compliance.

United States

Message

What I'm looking for

I’m looking for a remote-ready role where I can lead GxP quality systems, ensure data integrity, manage third-party lab performance, and drive zero-finding audits across global regulated environments.

I’m a results-driven pharmaceutical quality professional with 15+ years of expertise in analytical chemistry, regulatory compliance, document control, and laboratory operations across FDA, EMA, and MHRA-regulated environments.

I’ve managed and liaised with 5+ third-party contract laboratories globally, overseeing testing activities, compliance monitoring, and performance metrics—while maintaining zero critical audit findings and improving audit readiness from 1 finding prior to my role.

I’m especially proud of operational impact: I maintained a 95% on-time CAPA closure rate and led cross-functional quality initiatives across 19+ countries, ensuring alignment with GxP, GMP, and GLP standards in both on-site and fully remote settings.

I leverage electronic quality systems such as Veeva, LIMS, TrackWise, and Regulus to sustain data integrity across distributed sites, and I support annual product review and regulatory submissions with strong documentation rigor.

Experience

Work history, roles, and key accomplishments

Sr. Associate Coordinator

Elanco

Dec 2018 - Aug 2025 (6 years 8 months)

Managed and liaised with 5+ third-party contract laboratories globally, overseeing testing activities and compliance performance metrics. Authored 100+ quality documents annually, reviewed 100+ documents and 50+ laboratory analyses per year, and sustained zero critical audit findings while improving CAPA closure to 95% on time.

GMP GxP Document Control Analytical Chemistry Data Integrity Veeva Trackwise

External Stability Coordinator

Eli Lilly

Jan 2016 - Jan 2019 (3 years)

Oversaw external stability programs and ensured regulatory alignment with FDA, EMA, and MHRA requirements across global operations. Authored and reviewed stability protocols and annual product review reports while managing third-party testing and resolving quality issues to maintain rigorous documentation and data integrity.

Stability Testing Annual Product Review Protocol Authoring Data Integrity Quality Investigations & Regulatory

Sr. Chemist

Eli Lilly

Jan 2012 - Jan 2016 (4 years)

Supported a stability portfolio of 1,000+ APIs, related compounds, and impurities across external manufacturing and global QC laboratories, managing 10+ concurrent projects and multiple global markets. Completed 5+ annual product reviews per year with 100% on-time reporting, improving data accuracy by identifying and resolving inaccurate third-party integration and impurity reporting across multi-

Stability Testing Analytical Chemistry Annual Product Review GMP Compliance Cross Functional Collaboration

Chemist II / Biochemist II

Lancaster Laboratories

Jan 2008 - Jan 2012 (4 years)

Developed generic HPLC testing for multi-compound small and large molecule analyses, including urgent ID testing for final packaging products. Executed 15–25 tests weekly across 5+ client projects, maintained ≤5 business days reporting against a 5–7 day target, and achieved zero internal or external audit findings.

laboratory operations Data Reporting

DBA Lead / LOBA Manager

Advanced Testing Laboratories

Jan 2007 - Jan 2008 (1 year)

Led GC/MS method development and managed sample preparation and laboratory operations to support analytical reporting and client deliverables. Compiled and quantified raw scientific data, ensuring accuracy for chemistry-focused testing outputs.

GC MS Method Development laboratory operations