Company
GlobalLeadAuditor
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Global Lead Auditor. Skills: Global Audit Strategy & Governance, Regulatory & Standards Oversight, Leadership & Functional Oversight, Assurance & Risk Management, Reporting & Stakeholder Engagement. Providing strategic direction, governance, and leadership across all global Quality operations. Ensuring consistent implementation of the Global Quality Management System (QMS)”
What You'll Achieve.
Ensure consistent implementation of the Global Quality Management System (QMS); Drive compliance with all applicable GDP/GMP/GxP regulations; Elevate Quality standards globally; Provide independent assurance on compliance, quality systems, and risk management; Ensure audit frameworks reflect applicable GxP requirements and ISO standards; Provide expert oversight of compliance issues and regulatory inspection readiness; Provide independent assurance on the effectiveness of quality systems, internal controls, and regulatory compliance
Industry & Context.
Identifying systemic issues and cross-functional risks across global operations
International travel will be required to support global audits, site visits, training, supplier oversight, and cross‑regional collaboration
What They're Looking For.
Must Have
Extensive experience in regulated pharmaceutical or life sciences environments, Deep expertise in GxP regulations (GMP, GDP, GCP) and global regulatory frameworks, 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
Nice to Have
Quality or regulatory qualifications (e. g. QP, RQAP, ISO Lead Auditor), Experience managing regulatory inspections or major compliance programmes
What You'll Do.
Providing strategic direction
and leadership across all global Quality operations
Ensuring consistent implementation of the Global Quality Management System (QMS)
Driving compliance with all applicable GDP/GMP/GxP regulations
Partnering with regional and functional teams to elevate Quality standards globally
Leading both the internal and external audit function
Defining and maintaining the global audit strategy covering GxP and related quality systems
Establishing global audit policies
and methodologies aligned to EMA
and other regulatory requirements
Ensuring alignment of audit activities with enterprise risk management and quality management systems (QMS)
Overseeing global risk-based audit planning across all GxP activities
Identifying cost savings
operational & business process improvements
Supporting with maintaining global quality procedures and policies
Implementing global quality agreement templates to support vendor management process
Supporting audit findings relating to global quality procedures and policies
Ensuring audit frameworks reflect applicable GxP requirements and ISO standards
Monitoring regulatory trends and emerging compliance risks
Monitoring regulatory changes and guiding regions on the implementation of new or updated requirements
Providing expert oversight of compliance issues and regulatory inspection readiness
Leading and developing the global audit function
including direct management of the Internal and External Audit Leads
Coordinating the review and management of audit findings across global QA functions
facilitating cross‑functional input to determine acceptance or rejection of findings and driving updates to global SOPs and quality systems as required
and support to audit teams across regions and functions
Fostering a culture of quality
and continuous improvement
Providing independent assurance on the effectiveness of quality systems
and regulatory compliance
Identifying systemic issues and cross-functional risks across global operations
Driving continuous improvement initiatives in governance
and control frameworks
Reporting global audit outcomes
and key risks to executive leadership and the Audit Committee
Overseeing remediation of global audit findings and management action plans
and developing auditors across multiple regions
Promoting cross‑regional collaboration and knowledge-sharing
Ensuring regional and site leaders understand and accept responsibility for remediation
How You'll Work.
Team & Collaboration
Partnering with regional and functional teams to elevate Quality standards globally; Cross functional influence; Coordinating the review and management of audit findings across global QA functions, facilitating cross‑functional input; Providing direction, challenge, and support to audit teams across regions and functions; Promoting cross‑regional collaboration and knowledge-sharing
Communication Scope
Exceptional communication skills; Ability to engage credibly with regulators, senior leadership, and audit committees; Reporting global audit outcomes, trends, and key risks to executive leadership and the Audit Committee
Process & Methodology
Global audit planning, Management of audit findings, Remediation of global audit findings, Management action plans
Full Job Description
**Global Lead Auditor** **Full Time Permanent** **CityWest** **The Role** 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 Global Audit Lead provides independent assurance on compliance, quality systems, and risk management, and leads both the internal and external audit function. The role is a key advisor to senior leadership and the Audit Committee on regulatory, quality, and operational risk. **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 & business process improvements. * Support with maintaining global quality procedures and policies. * Implement global quality agreement templates to support vendor management process * 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 complianc
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