Engineering Compliance Management Lead

• Define and drive the Engineering Compliance framework, standards, and approach across Global Engineering.  

• Act as central interface between Global Engineering and Global Quality, serving as the Engineering Compliance SME by translating enterprise compliance frameworks and standards defined by Global Quality into practical Engineering implementation and execution. 

• Ensure visibility, consistency, and structured handling of Engineering compliance topics (e.g., findings, KPIs, inspection readiness).  

• Drive continuous improvement, harmonization, and digitalization of Engineering Compliance, including data-driven approaches.

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Engineering Compliance Framework & Governance 

• Define, maintain, and continuously improve the Engineering Compliance framework, standards, and processes across Global Engineering. 

• Ensure alignment with GxP and regulatory expectations and translate them into Engineering-specific requirements and guidance. 

• Interpret and operationalize enterprise compliance frameworks and standards defined by Global Quality within Engineering. 

Compliance Oversight, Transparency & Risk Management 

• Ensure global visibility and transparency of Eng. compliance topics (KPIs, inspection findings).  

• Establish and maintain structured tracking and reporting of compliance topics across GE.  

• Identify trends, systemic gaps, risks, and proactively drive mitigation and improvement actions.  

• Support inspection readiness by ensuring Engineering-related compliance risks are identified and addressed. 

• Contribute to and actively participate in the Community of Excellence (CoE) for Global Engineering departments. 

Global Coordination & Site Interface 

• Act as central interface for Eng Compliance topics between GE, Quality, and sites.  

• Drive implementation of Eng Compliance initiatives and ensure consistent application.  

• Support site preparation for inspections and audits in collaboration with CQV Leads.  

• Provide guidance and direction to CQV Leads for implementation and execution at site level. 

Integration with CQV & Lifecycle Activities 

• Ensure and enable implementation of Eng Compliance initiatives across sites through CQV Leads. 

• Collaborate closely with CQV Leads and Global Quality to ensure consistent and compliant implementation.  

Continuous Improvement & Compliance Excellence 

• Provide technical SME input and feedback to Global Quality to support continuous improvement of enterprise compliance frameworks and standards. 

• Drive continuous improvement and harmonization of Engineering Compliance processes.  

• Lead global initiatives to improve consistency, efficiency, and compliance performance.  

• Analyse compliance data, trends, and inspection outcomes to derive improvement measures.  

• Promote best practices and ensure knowledge sharing across Engineering.  

• Quality, Eng, and site functions to ensure aligned and inspection-ready.

Required 

• Degree in engineering or pharmaceutical science or equivalent  

• Languages: Business fluent proficiency in English  

• Experience: 10+ years in a GMP-regulated environment (Engineering, CQV, or Quality)  

• Strong knowledge of GxP and Engineering Compliance topics  

• Strong analytical mindset and problem-solving skills  

• High communication skills, ability to influence across functions  

• Strong collaboration and stakeholder management skills  

Preferred 

• Experience in CQV or validation lifecycle  

• Experience in multi-site or global roles