Overview
Associate Director, GE Commissioning and Qualification (CQ) (80-100%) (m/w/d) at Lonza. The role is based in Stein, Switzerland. Relocation assistance is available for eligible candidates. This role involves leading a Global Engineering CQ Lead Shared Function (Commissioning, Qualification) to ensure services and processes meet regulatory requirements and quality standards. This role is onsite full-time.
What You’ll Do
* Lead and manage a team of CQ experts.
* Oversee the generation of protocols for several projects, including lifecycle documents.
* Develop commissioning and qualification plans and reports.
* Oversee the alignment and execution of IV/IQ static testing across site projects.
* Collaborate with the CQ Portfolio Lead and other departments (engineering, manufacturing, quality, procurement, regulatory affairs) to improve CQ efficiency in terms of cost and schedule.
* Oversee several remote offices located in strategic locations worldwide to increase efficiency and reduce costs.
* Assess capability and capacity of supplier quality departments to ensure timely delivery of proper documentation.
* Lead CQV activities to ensure compliance with regulatory requirements and industry standards.
* Collaborate with cross-functional teams to identify and mitigate risks associated with CAPEX investments.
What We're Looking For
* Master's degree or equivalent in Pharma, Engineering, or Science
* Proven experience in Pharma/Engineering (GEP/GMP) with understanding of Fill and Finish facility building and processes
* Proven experience in Project Management, CQV, governance
* People management experience preferred
* Proficient in English; German is an advantage
* Understanding of Pharmaceutical/Biotech Contract Manufacturing business and experience with cGM
* Strong leadership skills with global interaction capability
* 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
Why Lonza?
Lonza is a global leader in life sciences, operating across five continents. We value ethical conduct, inclusion, and innovation. We offer a dynamic work culture, competitive salary, and a range of lifestyle, family, and leisure benefits. Relocation assistance is available for eligible candidates.
Reference: R68574
Seniority level
Not Applicable
Employment type
Contract
Job function
Business Development and Sales
Industries
Pharmaceutical Manufacturing
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