Director, CQV Project Delivery - US02 Lonza Biologics Inc.

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

The Director, CQ (Commissioning and Qualification) Project Delivery ensures that new equipment, facilities, and processes meet the regulatory requirements and quality standards.

The CQ Lead is responsible for managing and leading a team of engineers and technicians to develop and execute CQ protocols for new equipment, facilities, and processes in compliance with regulatory requirements and quality standards. They oversee the execution of commissioning and qualification activities, such as installation and operational qualification, and ensure that all documentation and reports are accurate and complete.

The CQ Lead collaborates with other departments, such as engineering, manufacturing, quality, and regulatory affairs, to ensure that CQ activities are integrated into the project plan and completed on time and within budget

Key Responsibilities:

• Calculate resource allocation, cost estimation, and timeline projection for successful CQ 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.
• 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 and qualification (CQ) strategies aligned with global standards for CAPEX investments portfolio.
• Lead CQ activities to ensure compliance with regulatory requirements and industry standards.
• Oversee project plans to ensure timely completion of CQ deliverables.
• Collaborate with cross-functional teams to identify and mitigate risks associated with CAPEX investments.
• Provide technical leadership and guidance for CQ activities according to industry standards.
• Develop and maintain relationships with key stakeholders for successful project execution.
• Conduct training sessions on CQ principles and best practices, identify opportunities for continuous improvement, and implement changes to optimize CQ processes.

Key Requirements:

• Bachelor’s Degree in Life Science or Engineering required. Master’s Degree preferred.
• 10+ years of relevant experience in increasing responsibility as it aligns with the scope of responsibilities above.
• Comprehensive understanding of Pharmaceutical/Bio Science "Contract Manufacturing" business and experienced in cGMP.
• Strong leadership skills with a global interaction capability.
• Possess financial and commercial acumen, able to link understanding to project goals, costs & scheduling, and risk.
• Experienced in calculating project-related resource needs, time, and costs.
• Experienced as CQ-Lead and/or Project Manager.
• Mature collaboration and influencing skills, able to work efficiently in a highly matrix environment with teams and individuals.
• Excellent command of English with desirable knowledge of German.
• Strong analytical skills for in-depth analysis of complex/large datasets, drawing conclusions and supporting decisions.
• Ability to work independently and as part of a team-oriented environment.
• Able to deal with ambiguity, conforming to shifting priorities and demands, prioritize and execute tasks in a fast-paced environment.
• Possess strong written and oral communication skills.
• Can develop and implement new and standard processes, tools/methodologies in a global context, lead and train/support colleagues.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.