Steve Campbell
Director, Supplier Quality Management @89bio
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WORK HISTORY
Director, Supplier Quality Management @89bio
San Francisco, CA, US
Lead the global supplier quality and compliance program supporting 89bio’s clinical and commercial manufacturing operations. Responsible for ensuring GxP vendor compliance with FDA, EMA, and ICH Q7 standards, while driving operational excellence across the organization- Built and implemented a supplier management system covering all clinical manufacturing vendors, incorporating risk-based classification, KPIs, and performance scorecards- Negotiate and execute complex Quality Agreements with contract service providers to ensure clear accountability and regulatory alignment- Established and manage the vendor audit program, including the Approved Vendor List, to ensure inspection readiness and sustained compliance- Partner with cross-functional stakeholders (QA, Supply Chain, Manufacturing, and Regulatory) to drive continuous improvement initiatives and supplier risk mitigation- Mentor and develop QA professionals supporting supplier qualification and audit activities.
EDUCATION
California State University-Dominguez Hills
Quality Assurance
Solano Community College
Biology
ABOUT STEVE CAMPBELL
With over two decades of experience in biologics and cell therapy quality systems, I have built a career leading supplier quality, quality assurance, and compliance programs across top-tier biopharma organizations. My passion lies in developing scalable, inspection-ready quality systems that not only meet regulatory expectations but drive operational excellence and partnership trust.Currently serving as Director, Supplier Management Quality, I lead the development of a comprehensive supplier management framework spanning all clinical manufacturing vendors—defining performance KPIs, risk-based oversight, and quality metrics that ensure consistent compliance and reliability. I negotiate and execute Quality Agreements that clarify accountability across complex global networks, and I oversee supplier audits under 21 CFR 210/211, ICH Q7, and ISO 9001 to maintain readiness and transparency.Throughout my career, I have:Built supplier quality programs from the ground up (89bio, Lyell Immunopharma)Directed quality investigations and CAPA processes to ensure regulatory alignment (Bristol Myers Squibb, AGC Biologics, Genentech/Roche)Led multi-site change control and audit programs supporting biologics manufacturing networksFostered strong collaboration between quality, manufacturing, and supply chain functions to enable continuous improvementRecognized for my balanced approach to compliance and partnership, I focus on helping organizations strengthen supplier relationships, anticipate quality risks, and deliver products that make a difference for patients worldwide.
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