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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Today, I challenge outdated thinking and guide forward-looking companies to rewire their quality, compliance, and leadership systems for agility, speed, and impact.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

  • Custom in-house AI education programs to demystify the tech and raise AI literacy across functions​

  • Real-world AI applications that improve compliance, reduce cost, and accelerate product release​

  • Smarter deviation/CAPA systems with predictive analytics and AI-enabled root cause support​

  • Strategies for integrating AI into your quality system—with built-in governance and validation frameworks

Quality Management Systems

From Bureaucracy to Competitive Advantage

  • QMS simplification for speed, flexibility, and leaner operations

  • Quality Maturity Model (QMM) expertise: assess, evolve, and lead

  • Human error prevention strategies grounded in behavioural science

  • Practical redesign of deviation and CAPA processes to prevent recurrence and drive learning

  • Crisis prevention: systems that absorb shock and adapt under pressure

Leadership Development

Built for High-Stakes Environments

  • 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

  • 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

Quality systems bloated?
Your team's firefighting?
Leadership overwhelmed?

Let’s talk.

I don’t do theory. I deliver practical, provocative solutions that work in the real world.

©2025 by CommQP Ltd. 

Registered in England.

Company No. 8022888

VAT Registration No. 132072652

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