Region CQV Lead, Europe/Asia

• Lead and coordinate CQV and Compliance Engineering activities across a defined region, ensuring compliant, efficient, and standardized execution across CAPEX projects and lifecycle phases, including support for inspection readiness and site preparedness. 

• Ensure execution of CQV activities (Commissioning, Qualification & Validation) across CAPEX projects and lifecycle in alignment with global strategies and standards. 

• Support and enable the use of paperless validation systems across sites. 

• Drive continuous improvement, innovation, and digitalization in CQV and Compliance Engineering, including AI- and data-driven approaches.

Strategy, Governance & Leadership 

• Actively lead and support CQV and Engineering Compliance strategy 

• Act as Single Point of Contact (SPoC) for sites for CQV and Compliance Engineering topics  

• Coordinate and oversee CQV and Compliance Engineering activities across assigned sites  

• Drive and implement global initiatives and ensure implementation at site level  

• Contribute to and actively participate in the Community of Excellence (CoE)  

• Lead Communities of Practice (CoPs) across sites 

• Partner with Global Quality, Eng, and site functions to ensure aligned and inspection ready. 

CQV Execution & Project Delivery 

• Ensure consistent and compliant execution of CQV activities across CAPEX projects: Support planning and coordination of CQV activities to meet timelines and regulatory expectations  

• Ensure alignment with global CQV standards and regulatory requirements 

• Collaborate with CSV / OT while maintaining clear accountability boundaries (no ownership of equipment qualification such as IQ/OQ/PQ). 

Validation Maintenance 

• Lead and ensure implementation of validation maintenance across sites  

• Ensure lifecycle validation activities (e.g., periodic review and requalification) are executed and maintained in a compliant state 

Compliance Engineering 

• Support implementation of Compliance Engineering frameworks, standards, and initiatives at site level, including support for inspection readiness and site preparedness 

• Act as site interface for Compliance Engineering topics, ensuring coordination and alignment between sites and global functions  

• Provide feedback, input, and lessons learned from sites to global Compliance Engineering 

Paperless Validation  

• Act as regional key contact for paperless validation systems 

• Support and enable effective use of digital validation tools across sites  

• Support system adoption, onboarding, and usage  

• Drive adoption and consistent use of digital and paperless validation solutions 

• Act as back-up for the Global Paperless Validation Lead to ensure continuity of operations and support 

Continuous Improvement & Innovation 

• Drive continuous improvement and standardization of CQV and Compliance Engineering activities across sites  

• Lead implementation of innovation and digitalization initiatives (e.g., AI-driven approaches) at site level  

• Promote best practice sharing and harmonization across sites and within Global Engineering 

Digital Validation, Innovation & Continuous Improvement 

• Drive adoption of digital and paperless validation solutions. 

• Lead global and site-level initiatives to enhance efficiency, quality, and standardization across CSV & OT compliance. 

Required 

• Degree in engineering or pharmaceutical science or equivalent  

• Experience managing CQV activities in major CAPEX projects 

• Languages: Business fluent proficiency in English  

• Experience: 5+ years in CQV, GMP-regulated project management, or operations in the pharmaceutical industry  

• Strong knowledge of GxP, CQV processes and validation lifecycle   

• High communication skills, analytical mindset, ability to work under pressure  

• Strong collaboration and stakeholder management skills 

Preferred 

• Experience in Manufacturing or operations  

• Experience with digital validation tools