GMP Leaders Mindset

Transform how your leaders think about GMP, compliance, and quality culture

GMP Leaders Mindset is a bespoke, face-to-face leadership program designed to shift how organisations in regulated environments lead, own, and embed GMP.

Co-facilitated by PharmOut GMP expert Maria Mylonas and global thought leader Jason Clarke (Minds at Work), this program goes beyond traditional GMP training.

It challenges leaders to rethink their role in compliance – moving from delegation to ownership, and from inspection-driven behaviour to proactive quality leadership.

Maria-Mylonas

Maria Mylonas

PharmOut, Business Development Director
A highly experienced GMP expert, Maria brings deep, practical knowledge of regulatory expectations and real-world compliance challenges across regulated industries.
jason-clarke-minds-at-work-founder

Jason Clarke

Minds at Work, Founder
Jason Clarke, founder of Minds at Work, is a leading Australian creative thinker who helps organisations improve how they think and solve problems. He specialises in creativity, innovation, leadership, and culture change, guiding teams to unlock better ideas, challenge assumptions, and make clearer decisions.

With a strong focus on practical outcomes, he helps organisations turn complex challenges into actionable strategies. His engaging facilitation style enables teams to think more clearly, creatively, and confidently in fast-changing environments.

Course Overview GMP Leaders Mindset

This program focuses on how leaders think, decide, and act in a regulated environment, and how those behaviours shape the organisation’s quality culture.

GMP Leadership Mindset

Regulated Organisations

In many regulated organisations, GMP is still seen as the responsibility of Quality.

  • Reactive compliance driven by audits and inspections
  • Tick-box behaviours and workarounds
  • Tension between commercial delivery and regulatory expectations
  • Quality teams that are not fully empowered

GMP Expertise and Advanced Thinking Methodologies

Delivered through a combination of GMP expertise and advanced thinking methodologies, this course enables leaders to:

  • Understand how their decisions impact compliance outcomes
  • Actively sponsor and model the right quality behaviours
  • Navigate competing pressures with confidence
  • Build a culture where GMP is owned across the business
GMP Expertise and Thinking Methodologies

Who Should Attend

This program is designed for leadership teams and senior decision-makers in regulated environments, including:

  • Senior Executives (CEO, GM, MD)
  • Site Heads and Plant Managers
  • Heads of Quality and QA Leaders
  • Operations and Manufacturing Leaders
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  • R&D and Technical Directors
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training terms and conditions
gmp-training-courses-cgmp-requirements

What You’ll Learn

By the end of this program, leaders will be able to:

  • Take ownership of GMP beyond QA: Understand their role in driving compliance outcomes across the organisation
  • Lead and influence quality culture: Move from passive support to active sponsorship of GMP
  • Make better decisions under pressure: Balance commercial priorities with regulatory expectations
  • Recognise and challenge poor behaviours: Address workarounds, silence, and tick-box compliance
  • Shift from reactive to proactive compliance: Embed GMP into everyday decision-making, not just inspection readiness
  • Align leadership behaviours with regulatory expectations: Create consistency between what leaders say and what they do

Industries We Support

This program is relevant across all regulated GMP environments. Examples and discussions are tailored to reflect your industry context and regulatory challenges:

  • Pharmaceutical manufacturing
  • Veterinary medicines
  • Medical devices
  • Blood and tissue products

Delivery

  • Format: Onsite or Online
  • Structure: Tailored to your organisation’s needs
  • Customisation: Content is adapted to your:
  • Regulatory environment
  • Leadership challenges
  • Organisational maturity

Quality Culture

Strong GMP performance starts with leadership. GMP Leaders Mindshift helps your leaders move from:

  • Delegation → Ownership
  • Compliance pressure → Confident decision-making
  • Reactive behaviour → Sustainable quality culture

Course Duration

Flexible, needs-based delivery designed to suit your team, operational priorities, and learning outcomes:

  • Tailored based on training needs analysis
  • Typically delivered across 3–4 sessions
  • Sessions run approximately 5–7 hours

Talk to PharmOut

Speak to PharmOut about designing a GMP Leaders Mindset program tailored to your organisation.

Contact PharmOut Today