CQV Manager – CAPEX (7135)

Lead CQV Strategy for Global Pharmaceutical Innovation

Join a global market leader in the production and process support of active pharmaceutical ingredients across chemical and biotechnology sectors. Based in Visp, Switzerland, this role offers a 12-month contract with high potential for extension. As a key member of the team, you will ensure that new equipment, facilities, and processes meet rigorous regulatory requirements and quality standards.

Key Responsibilities

• Manage and lead a team of engineers and technicians to develop and execute CQV protocols for new equipment, facilities, and processes in compliance with regulatory requirements and corporate quality standards.
• Oversee the execution of qualification and validation activities, including installation and operational qualification, ensuring all documentation and reports are accurate and complete.
• Collaborate with engineering, manufacturing, quality, and regulatory affairs departments to integrate CQV activities into project plans, ensuring timely completion within budget.
• Calculate resource allocation, cost estimation, and timeline projections for CAPEX projects, facilitating meetings to highlight schedule targets, resolve issues, and escalate when necessary.
• Manage project staffing by identifying and leading internal or external resources for appropriate execution.
• Oversee remote offices located in strategic locations globally to increase efficiency and reduce costs.
• Act as a subject matter expert in developing Project Execution Plans and Project Quality Plans, participating in relevant committees.
• Develop and implement CQV strategies aligned with global standards for the CAPEX investment portfolio.
• Lead CQV activities to ensure compliance with regulatory requirements and industry standards.
• Oversee project plans to ensure the timely completion of CQV deliverables.
• 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 to support successful project execution.
• Conduct training sessions on CQV principles and best practices, identifying opportunities for continuous improvement and implementing changes to optimize processes.

Qualifications and Experience

• Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required.
• Master’s Degree in Pharma, Engineering, or Science.
• 5-10 years of experience with CQV and Project Management.
• Comprehensive understanding of Pharmaceutical/Bio Science "Contract Manufacturing" business and experience in cGMP.
• Comprehensive understanding of Fill and Finish Facility Building and processes.
• Strong leadership skills with global interaction capability.
• Financial and commercial acumen, with the ability to link understanding to project goals, costs, scheduling, and risk.
• Experience in calculating project-related resource needs, time, and costs.
• Experience as a CQV Lead and/or Project Manager.
• Required CAPEX BioPharma experience.
• Mature collaboration and influencing skills, with the ability to work efficiently in a highly matrix environment.
• Strong analytical skills for in-depth analysis of complex or large datasets, drawing conclusions and supporting decisions.
• Ability to work independently and as part of a team-oriented environment.
• Ability to deal with ambiguity, conforming to shifting priorities and demands, prioritizing and executing tasks in a fast-paced environment.
• Strong written and oral communication skills.
• NEAT required; Deltav is an advantage.
• Fluent English, with German preferred.