Overview
The Global Quality Lead is responsible for providing strategic direction, governance, and leadership across all global Quality operations. This role ensures consistent implementation of the Global Quality Management System (QMS), drives compliance with all applicable GDP/GMP/GxP regulations, and partners with regional and functional teams to elevate Quality standards globally. The position requires strong cross-functional influence, exceptional communication skills, and the ability to lead quality initiatives across multiple regions, cultures, and business units.
The Role (full-time, permanent) — CityWest: The Global Quality Lead provides strategic direction, governance, and leadership across all global Quality operations, ensuring consistent implementation of the Global Quality Management System (QMS) and compliance with GDP/GMP/GxP regulations. The role involves partnering with regional and functional teams to elevate Quality standards globally.
Responsibilities
Global Audit Strategy & Governance
Define and maintain the global audit strategy covering GxP and related quality systems.
Establish global audit policies, procedures, and methodologies aligned to EMA, ICH, FDA, MHRA, and other regulatory requirements.
Ensure alignment of audit activities with enterprise risk management and quality management systems (QMS).
Oversee global risk-based audit planning across all GxP activities.
Identify cost savings, operational and business process improvements.
Support with maintaining global quality procedures and policies.
Support audit findings relating to global quality procedures and policies.
Regulatory & Standards Oversight
Ensure audit frameworks reflect applicable GxP requirements and ISO standards.
Monitor regulatory trends and emerging compliance risks.
Monitor regulatory changes and guide regions on the implementation of new or updated requirements.
Provide expert oversight of compliance issues and regulatory inspection readiness.
Leadership & Functional Oversight
Lead and develop the global audit function, including direct management of the Internal and External Audit Leads.
Provide direction, challenge, and support to audit teams across regions and functions.
Foster a strong culture of quality, compliance, and continuous improvement.
Assurance & Risk Management
Provide independent assurance on the effectiveness of quality systems, internal controls, and regulatory compliance.
Identify systemic issues and cross-functional risks across global operations.
Drive continuous improvement initiatives in governance, quality, and control frameworks.
Reporting & Stakeholder Engagement
Report global audit outcomes, trends, and key risks to executive leadership and the Audit Committee.
Act as a senior partner to the leadership team and foster a culture of Continuous Improvement.
Oversee remediation of global audit findings and management action plans.
Provide Strategic Leadership for the Global Audit Program.
Recruit, mentor, and develop auditors across multiple regions.
Promote cross-regional collaboration and knowledge-sharing.
Ensure regional and site leaders understand and accept responsibility for remediation.
Maintain Uniphi communication and presence.
Essential – Key Skills and Experience
Extensive experience in regulated pharmaceutical or life sciences environments.
Deep expertise in GxP regulations (GMP, GDP, GCP) and global regulatory frameworks.
Strong knowledge of ISO standards and quality management systems.
Proven leadership of global audit or quality assurance functions.
Ability to engage credibly with regulators, senior leadership, and audit committees.
International travel will be required to support global audits, site visits, training, supplier oversight, and cross-regional collaboration.
Desirable
Quality or regulatory qualifications (e.g. QP, RQAP, ISO Lead Auditor).
Experience managing regulatory inspections or major compliance programmes.
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