Serving the pharmaceutical industry since 2006.
Executive Leadership for a New Era of Biotech Operations & Quality
Martin Lush
​Executive Leader | Qualified Person | GxP AI Strategist | QMS Simplification Expert | Non-Executive Director
With over 40 years at the intersection of biotech operations, pharmaceutical quality, and regulatory compliance, I help organizations navigate complexity, modernize their systems, and build real resilience in an unpredictable world.
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I’ve led from the shop floor to the boardroom—serving as Global VP in consulting, QA, manufacturing, operations, and supply chain across vaccines, biologics, and sterile injectables. I’m a Qualified Person under permanent provisions and a Non-Executive Director, with deep insight into both execution and oversight.
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Today, I challenge outdated thinking and guide forward-looking companies to rewire their quality, compliance, and leadership systems for agility, speed, and impact.
What do I do?
GxP AI Implementation
Practical,
Compliant,
Game-Changing
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Custom in-house AI education programs to demystify the tech and raise AI literacy across functions​
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Real-world AI applications that improve compliance, reduce cost, and accelerate product release​
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Smarter deviation/CAPA systems with predictive analytics and AI-enabled root cause support​
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Strategies for integrating AI into your quality system—with built-in governance and validation frameworks
Quality Management Systems
From Bureaucracy to Competitive Advantage
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QMS simplification for speed, flexibility, and leaner operations
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Quality Maturity Model (QMM) expertise: assess, evolve, and lead
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Human error prevention strategies grounded in behavioural science
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Practical redesign of deviation and CAPA processes to prevent recurrence and drive learning
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Crisis prevention: systems that absorb shock and adapt under pressure
Leadership Development
Built for High-Stakes Environments
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One-to-one coaching for senior leaders under pressure
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Embedding risk-based decision making and psychological resilience across teams
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Culture transformation rooted in accountability, clarity, and future-readiness
Regulatory Compliance
Prepared for What's Next
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Proactive FDA readiness, including strategy for the new regulatory realities of a Trump 2.0 era
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Inspection prep that goes beyond checklists—focused on mindset, micro-behaviours, and risk-based thinking
