Associate Director, GE Commissioning and Qualification (CQ) (80-100%) (m / w / d)

Lonza; Wittnau; Vor Ort; CHF 100’000 - 130’000; Vollzeit

Zusammenfassung

Lonza seeks a Global Engineering CQ Lead Shared Function to oversee compliance and quality assurance processes. The successful candidate will lead CQ activities, manage teams, and ensure regulatory adherence while collaborating with various departments. This role offers the opportunity to make a significant impact in the life sciences field through engineering excellence.

Qualifikationen

• Proven experience in Pharma / Engineering (GEP / GMP).
• Understanding of Fill and Finish Facility Building and processes.
• Experience in CQV and global interactions.

Aufgaben

• Lead a team of CQ experts overseeing project protocols.
• Ensure compliance with regulatory requirements and industry standards.
• Collaborate with global teams to improve efficiency and reduce costs.

Kenntnisse

Leadership

Project Management

Analytical Skills

Ausbildung

Master's Degree in Pharma, Engineering, or Science

Jobbeschreibung

Today, Lonza is a global leader in life sciences operating across five 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.

We are hiring for a driven Global Engineering CQ Lead Shared Function (Commissioning, Qualification). In this role, you will ensure that services and processes meet regulatory requirements and quality standards.

Join our ambitious team and help deliver world-class engineering projects. This is an outstanding opportunity to contribute to innovative CQ projects in Switzerland!

The role is based in Stein, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed. This role involves being onsite full time.

Key responsibilities :

• Responsible for handling and leading a team of CQ experts.
• Oversee the generation of all protocols for several projects such as lifecycle documents.
• Commissioning and qualification plan and report.
• Oversee the alignment and execution of IV / IQ static testing across all site projects.
• The GE CQ Lead shared function will mainly support all the CQ Portfolio leads but also collaborates with other departments, such as engineering, manufacturing, quality, procurement, and regulatory affairs, to improve efficiency regarding cost and timeline.
• Oversee several remote offices located in different strategic locations across the globe to increase efficiency and reduce costs.
• Assess the capability and capacity of all suppliers' quality departments to ensure proper documentation delivery in a timely manner.
• Collaborate with different CQ Portfolio leads to ensure documentation alignment across all VISP projects.
• 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.
• Provide technical leadership and guidance for CQV activities according to industry standards.
• Develop and maintain relationships with key stakeholders for successful project execution.

Key requirements :

• Master's Degree or equivalent experience in Pharma, Engineering, or Science.
• Proven experience in Pharma / Engineering (GEP / GMP) with an understanding of Fill and Finish Facility Building and processes.
• Proven experience in Project Management, CQV.
• Proficient in English, German is an advantage.
• Understanding of Pharmaceutical / Bio Science "Contract Manufacturing" business and experience in cGMP.
• Strong leadership skills with a capability for global interaction.
• Financial and commercial acumen, linking understanding to project goals, costs, scheduling, and risk.
• Strong analytical skills for analyzing complex datasets, drawing conclusions, and supporting decisions.
• Ability to develop and implement new and standard processes, tools, and methodologies in a global context, leading and supporting colleagues.

Every day, Lonza’s products and services positively impact millions of people. For us, this is both a privilege and a responsibility. We achieve our business results ethically, respecting and protecting our people and environment.

People choose Lonza for the challenge and creativity involved in solving complex problems and developing new ideas in life sciences. We offer the satisfaction of improving lives worldwide and making a meaningful difference.

Inclusion is one of Lonza’s four core values, alongside integrity, innovation, and initiative. We value our differences and the contributions of every individual, regardless of characteristics, preferences, and beliefs—including race, color, ethnicity, sexual orientation, gender identity, and religion.