Derek Johnston
Director, Intelligence Compliance & Quality Integration Management @Gilead Sciences
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WORK HISTORY
Director, Intelligence Compliance & Quality Integration Management @Gilead Sciences
Cambridge, GB
As Director of Intelligence Compliance & QMS Integration, I lead strategic initiatives to strengthen and evolve two key areas: GxP Regulatory Compliance Intelligence – Driving proactive compliance by monitoring for, and implementing, the evolving legislation and regulatory requirements across GLP, GCP, and GVP domains. Quality Integration – Advise on integration efforts to ensure seamless alignment of external assets and partnerships with Gilead’s QMS, supporting cross-company collaborations.I work cross-functionally with Clinical Development, Legal, IT, and Pharmaceutical Development teams to enhance core QMS capabilities—spanning audits, inspections, vendor quality, documentation, training, and digital tools. I also contribute to the development of frameworks that support sustainable change and integration processes across the R&D landscape.
EDUCATION
Middlesex University
BSc. Hons. Herbal Medicine
SKILLS
ABOUT DEREK JOHNSTON
Results driven leader with over 20 years drug & device development experience and 10+ years in senior management capacity in gxp quality assurance and regulatory compliance. extensive expertise in regulatory intelligence, compliance strategy, and industry best practice within Pharma and CROs. Adept at leading global teams, ensuring regulatory adherence and providing strategic guidance to internal and external stakeholders to navigate the changing landscape. Passionate about fostering compliance excellence and contributing to industry advancements through active participation in professional networks and conferences.Expertise & Achievements:• R&D Quality Systems Leadership – Governance, maintenance, and strategic improvement. • GxP Compliance & Regulatory Intelligence – Ensuring continuous compliance in global markets. • Process Improvement & Change Management – Championing best practices and cross-functional collaboration. • Audit & Inspection Readiness – Leading regulatory inspections and global audit strategies. • Stakeholder Engagement & Leadership – Partnering with R&D, Quality, and Compliance teams. • Pharmaceuticals, Medical Devices, and Combination Products – Regulatory and quality expertise.• Panelist at the ACT EU Multi-Stakeholder Platform meeting.• ACRO representative at the MHRA StEM on ICH GCP E6(R3).• ACRO DCT Working Party founder member since established in 2019.• Member of ACRO’s EU Scientific and Regulatory & US Regulatory Committees.• ABPI Phase I Advisory Group - ACRO representative.• Member of the ABPIs Regulatory Expert Network.• Member of RQA.
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