Director of Quality

CDMO | US Site | Reporting to Chief Quality Officer

Role Overview

The Quality Director reports to the Chief Quality Officer, with a dotted line to the Head of CDMO, US, and provides strategic leadership for end-to-end Quality across the site. The role is accountable for ensuring GMP manufacturing and GLP laboratory operations remain compliant with FDA, EU GMP, GLP and applicable global regulatory requirements, while enabling disciplined, efficient and commercially aligned business performance.

This role calls for a strategic, growth-minded Quality executive who can strengthen site performance, develop enterprise capability, build succession depth and deliver measurable continuous improvement. The successful candidate will demonstrate the leadership maturity, business judgement and organisational influence required for broader corporate Quality leadership and potential Chief Quality Officer succession.

Key Responsibilities

Quality Leadership & Compliance

• Establish and mature the corporate Quality function by standardising global processes, strengthening governance and simplifying Quality Systems across the organisation.
• Maintain an effective global Pharmaceutical Quality System aligned with ICH Q10 and applicable FDA, EU GMP, GLP and internal standards.
• Ensure the site operates in a sustained state of compliance with regulatory, client and internal Quality expectations.
• Act as primary Quality representative during regulatory inspections and client audits.
• Provide executive oversight of batch certification, deviations, CAPA, change control, complaints and recalls, validation and qualification activities.
• Set the expectation for a proactive Quality culture grounded in Right-First-Time performance, data integrity, accountability and risk-based decision-making.

Strategic Quality & Business Integration

• Translate corporate strategy into global and site-level Quality objectives, KPIs and continuous improvement priorities that deliver measurable business, compliance and operational outcomes.
• Serve as a strategic business partner to site leadership, operations, commercial and global Quality stakeholders.
• Drive compliance while balancing phase-appropriate requirements alongside cost and process improvements.
• Enable business growth through reliable product release, inspection readiness and regulatory approval support.
• Support client interactions and proposals by positioning the organisation's Quality capabilities as credible, competitive and inspection-ready.

Continuous Improvement & Operational Excellence

• Champion continuous improvement using Lean, Six Sigma, digital tools and data-driven Quality insights.
• Deliver measurable improvements in batch release cycle time, deviation closure, Right-First-Time performance and Cost of Poor Quality while maintaining compliance.
• Simplify Quality processes and strengthen KPI management, governance and decision-making discipline.

People & Organisational Leadership

• Build, coach and develop a high-performing corporate and site Quality organisation with clear development pathways and leadership depth.
• Foster a culture of accountability, ownership, risk-based thinking and cross-functional collaboration.
• Develop succession plans and capability-building roadmaps that strengthen corporate Quality leadership depth and support long-term Chief Quality Officer succession readiness.
• Model pragmatic GMP leadership and coach teams to apply Quality standards in a scalable, business-aligned manner.
• Implement robust Quality risk management practices aligned with ICH Q9.
• Provide executive leadership for regulatory inspection readiness, client audit preparedness and timely resolution of critical Quality risks.
• Anticipate regulatory trends and proactively address compliance risks.
• Lead executive escalation, decision-making and stakeholder communication for critical Quality issues, ensuring timely risk mitigation and organisational alignment.
• Innovation: advances scalable Quality systems, digital tools and continuous improvement practices that strengthen compliance and operational performance.
• Patient focus: maintains an uncompromising focus on product quality, patient safety and reliable delivery of client commitments.
• Communication: engages transparently with site, corporate, regulatory, client and cross-functional stakeholders, ensuring timely escalation and clear decision-making.
• Accountability: owns Quality outcomes, inspection readiness, risk management and measurable performance improvement.
• Reliability: builds disciplined governance, sustainable processes, succession depth and trusted partnerships across the organisation.
• Excellence: sets high standards for Quality leadership, talent development, operational execution and continuous improvement delivery.

Key Qualifications & Experience

The ideal candidate is a strategic, growth-oriented Quality executive with the judgement, influence and operational discipline required to elevate site performance while building enterprise capability. This leader develops high-performing teams,…