NVision Imaging Technologies · 2 months ago
Validation Manager (Pharmatech Industry) (m/f/d)
United States
Full-time
Remote
Senior Level
5+ years expNVision Imaging Technologies is a quantum biotech startup focused on innovative drug development. The Validation Manager will oversee all validation activities, ensuring products meet quality and regulatory standards while collaborating with multidisciplinary teams and external partners.
BiopharmaBiotechnologyHealth DiagnosticsMedical DevicePharmaceutical
Responsibilities
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
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
Qualification
Required
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
Benefits
Competitive compensation, based on base salary and stock options
Hybrid working model
Indefinite employment contract, providing stability
Long-term career growth opportunities
30 vacation days
Relocation support
Company
NVision Imaging Technologies
NVision Imaging Technologies develops Quantum MRI agents for assessing early patient response to treatment at the metabolic level.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$100.24MKey Investors
StealthPlayground Global
2025-01-01Grant· $1.53M
2024-12-20Series B· $26.08M
2024-11-01Grant· $1.7M
Leadership Team
Sella Brosh
Chief Executive Officer
Recent News
2025-12-09
2025-04-02
2025-04-02
Company data provided by crunchbase