Head of Computerized System Validation (CSV) (all genders)

Your Challenge

We are looking for a skilled and driven leader to join our global quality team. As the Head of Computerized System Validation (CSV), you will lead and harmonize global CSV processes, ensuring their effectiveness and compliance. Your role will focus on driving validation activities, optimizing processes, and fostering collaboration across the organization.

Your main responsibilities will include:

• Harmonize and optimize the global CSV process, ensuring compliance and effectiveness.
• Lead global CSV projects from a Quality Validation perspective.
• Train and upskill CSV team members to maintain and improve technical expertise.
• Manage cross-functional projects and collaborate with key stakeholders.
• Review and approve CSV documentation to ensure regulatory compliance.
• Drive risk analysis in CSV projects, ensuring proactive risk management.

Your profile

• Hold a Bachelor’s degree in a relevant life science or engineering discipline.
• Bring over 10 years of experience in international quality engineering with a focus on CSV.
• Have more than a decade of expertise in the medical device sector.
• Possess a deep understanding of leading QM processes and tools.
• Demonstrate proven leadership abilities in managing strategic quality initiatives.
• Showcase autonomy and a proactive approach to your work.
• Previous exposure to global companies and diverse cultures is advantageous.
• Be proficient in English; additional languages are considered a plus.
• Office location: Kremsmünster (AT), Frickenhausen (DE) or Monroe (USA).

Our Offer

We offer you a role in a global QM environment with the opportunity to further develop your existing qualifications. In addition to our many attractive social benefits, the minimum annual salary in Austria is based on employment group IV of the collective agreement for the chemical industry. In other countries, compensation may vary based on local market conditions and legal frameworks.