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 supportCQV 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 activelyparticipatein the Community of Excellence (CoE) 

• Lead Communities of Practice (CoPs) across sites

• Partner with Global Quality,Eng, and site functions to ensurealignedandinspection 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 whilemaintainingclear 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 andmaintainedin a compliant state

Compliance Engineering

• Support implementationof Compliance Engineering frameworks, standards, andinitiativesatsitelevel,including support for inspection readiness and site preparedness

• Actassiteinterfacefor Compliance Engineeringtopics,ensuringcoordinationandalignmentbetweensitesand globalfunctions

• Provide feedback, input, andlessonslearnedfromsitesto global ComplianceEngineering

PaperlessValidation 

• 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 ValidationLeadto 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 sitesand within Global Engineering

Digital Validation, Innovation & Continuous Improvement

• Drive adoption of digital and paperlessvalidationsolutions.

• Lead global and site-levelinitiativestoenhanceefficiency,quality, andstandardizationacrossCSV & OT compliance.

Required

• Degree in engineeringorpharmaceuticalscienceorequivalent

• ExperiencemanagingCQVactivitiesinmajorCAPEXprojects

• Languages: Businessfluentproficiencyin English 

• Experience:5+yearsin CQV, GMP-regulatedprojectmanagement,oroperations inthepharmaceuticalindustry

• StrongknowledgeofGxP,CQVprocessesandvalidationlifecycle

• High communicationskills,analyticalmindset,abilitytoworkunderpressure

• Strongcollaborationandstakeholdermanagementskills

Preferred

• Experience in Manufacturingoroperations 

• Experiencewithdigitalvalidationtools