Validation Manager (Pharmatech Industry) (m/f/d)
NVision Imaging Technologies
Validation Manager (Pharmatech Industry) (m/f/d)
Your mission
Key responsibilities:
Reporting to the Senior Director of Quality, the Validation Manager will have responsibility to develop and manage all validation activities under the Quality Management System:
- Provide expert advice on the validation strategy for development programs.
- Develop and maintain the Validation Master Plan (VMP).
- Develop systems, processes, tools and templates for the conduct of qualification and validation activities.
- Work cross functionally to develop qualification and validation protocols in accordance with the requirements of the VMP.
- Review and approve qualification and validation reports.
- Project Management of validation activities.
- Initiate and manage deviations, changes and risk assessments in the conduct of validation activities.
- Quality oversight of the stability program.
- Quality oversight and support for technical transfer activities.
- Support the ongoing continuous improvement of the company’s QMS in compliance with applicable GxP requirements and regulatory guidelines.
- Leading Quality Excellence:
- Lead by example in promoting and facilitating a quality culture.
- Work cross functionally to provide quality oversight, support and expertise in the conduct of quality related activities across development projects, employing Quality by Design (QbD) principles.
- Provide training to staff on quality topics.
- Support the conduct of quality investigations and initiatives.
- Prepare, manage and present materials for Quality Management Review.
Your profile
- At least 5 years of hands-on experience of validation in a GMP sterile manufacturing environment, ideally in a development setting.
- Strong understanding of and experience of GMP requirements in the EU and US and sound knowledge of applicable ICH guidelines.
- Demonstrated expertise in the management of validation activities.
- Experience of method validation, process validation and equipment qualification.
- Experience of Computer System validation is an advantage.
- Excellent problem-solving, analytical, and communication skills.
- Familiarity with electronic Quality Management Systems (eQMS).
- Fluent in English.
Why us?
- Attractive compensation package, including a competitive base salary and stock options
- Key role in a highly advanced and fast-growing startup company
- Impactful product promoting better understanding and treatment of cancer
- International team, from over 30 different nationalities
- Positive work environment with open communication and a collaborative mindset
- Onsite work at state-of-the-art facilities with home-office opportunities I Hybrid model
- Indefinite employment contract
- 30 vacation days
- Flexible working hours
- Annual health budget (Allianz bKV)
- EGYM Wellpass
- Relocation support
Contact information
Join us in making a difference! Submit your application to be considered for this exciting opportunity.
Any questions? Please contact:
Sandra Schärli
Senior Talent Acquisition Manager
mail: careers@nvision-imaging.com
About us
NVision is innovating quantum technology with a unique approach - leveraging organic molecules to change lives for the better. Our platform spans from quantum signal enhancement that enables metabolic imaging today to quantum computing that could transform drug discovery tomorrow. Headquartered in Ulm, Germany, and backed by leading investors from the United States and Europe, we are now entering a phase of global commercialization and expansion.
With our POLARIS product line, we are extending the capabilities of standard MRIs to enable real-time metabolic imaging, transforming how diseases are detected, understood, and treated. Our work sits at the intersection of physics, engineering, chemistry, and medicine - translating cutting-edge science into clinical reality. We collaborate with leading academic and clinical partners worldwide, including Memorial Sloan Kettering Cancer Center, MD Anderson Cancer Center, Technical University of Munich, and the University of Cambridge.
At NVision, we believe transformative innovation happens when talented people from different disciplines work together toward a shared, meaningful goal. We are a global, multidisciplinary team of nearly 150 employees from more than 30 nationalities, driven by curiosity, rigor, and a commitment to solving complex challenges. Here, ideas are valued, ownership is real, and collaboration spans functions, disciplines, and borders.
If you are motivated by impact, thrive in dynamic environments, and want to contribute to something fundamentally new, NVision offers the opportunity to grow while building technology that changes lives.
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