CQV Manager

Main 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, such as installation and operational qualification, ensuring that all documentation and reports are accurate and complete

·Collaborate with other departments, such as engineering, manufacturing, quality and regulatory affairs, to ensure that CQV activities are integrated into the project plan and completed on time and within budget

·Calculate resource allocation, cost estimation, and timeline projection for successful CQV execution in assigned portfolio of CAPEX projects, ensuring the completion of all tasks within schedule through 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

·Oversee several remote offices which will be located in different strategic location across the globe to increase efficiency and to reduce Cost

·Act as subject matter expert (SME) in developing Project Execution Plan and Project Quality Plan and involved committees

·Develop and implement commissioning, qualification, and validation (CQV) strategies aligned with global standards for CAPEX investments portfolio

·Lead CQV activities to ensure compliance with regulatory requirements and industry standards.

·Oversee project plans to ensure timely completion of CQV deliverable.

·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

·Conduct training sessions on CQV principles and best practices, identify opportunities for continuous improvement, and implement changes to optimize CQV processes

Qualifications and Experience:

·Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required

·Master Degree in Pharma/Engineering/Science

·5-10 years of experience with CQV & Project Management

·Comprehensive understanding of Pharmaceutical/Bio Science "Contract Manufacturing" business and experienced in cGMP.

·Comprehensive understanding of Fill and Finish Facility Building and processes.

·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 CQV-Lead and/or Project Manager

·CAPEX BioPharma experience is needed

·Mature collaboration and influencing skills, able to work efficiently in a highly matrix environment with teams and individuals.

·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.

·NEAT Required , Deltav advantage

·Fluent English while German is preferred