Senior Manager, GE CQ

Senior Manager, GE CQ

Lonza

Visp, Switzerland

What you will do

• Responsible for managing and leading a team of engineers in charge to apply regulatory requirements and quality standards.
• Oversee the execution of qualification activities on several small projects.
• Represent the GE CQ department during internal Audit (GQC, GQE) or external Audit/Inspection (SwissMedic, FDA e.g.).
• Calculate resource allocation, cost estimation, and timeline projection for successful CQV execution in assigned portfolio of CAPEX projects, ensuring the completion of all tasks within schedule through daily meetings with team members and resources to highlight and communicate schedule targets, resolve issues, and escalate when necessary.
• Will be in charge of internal and External Audit/Inspection preparation and presentation.
• Manage staffing for projects, identify and lead internal or external resources for appropriate project execution.
• Act as subject matter expert (SME) in developing Project Execution Plan and Project Quality Plan and involved committees.
• Develop and implement commissioning, qualification (CQ) strategies aligned with global standards for CAPEX investments portfolio.
• Lead CQV activities to ensure compliance with regulatory requirements and industry standards.

What we are looking for

• Master Degree or equivalent experience in Pharma, Engineering, or Science.
• Proficient in English, German is an advantage.
• Proven experience in Pharma/Engineering (GEP/GMP) and CQV Project Management.
• Comprehensive understanding of Pharmaceutical/Bio Science "Contract Manufacturing" business and experienced in cGMP.
• Presentation skills during Audit/Inspection from internal QA department or from Authorities such as SwissMedic, FDA e.g.
• Strong leadership skills with a global interaction capability.
• Possess financial and commercial acumen, able to link understanding to project goals, costs & scheduling, and risk.
• Strong analytical skills for in-depth analysis of complex/large datasets, drawing conclusions and supporting decisions.