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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