Manager, Computer System Validation (CSV)

As Manager / Senior Manager Computerized System Validation you will lead the transformation of CSV practices within a dynamic contract research organization. Leveraging deep expertise in global regulatory requirements including FDA EMA GCP and ICH guidelines you will ensure validation processes are risk-based efficient and compliant. You will be responsible for interpreting and applying these regulations pragmatically to both off-the-shelf and custom-developed software solutions enabling agile software delivery while maintaining the highest standards of quality and compliance. This role requires a collaborative leader who partners effectively with Technology Product Quality and operational teams advocates for practical and common-sense solutions and drives continuous improvement in technology and clinical research operations.

Responsibilities

• The Manager / Senior Manager CSV will be responsible for the following :

Computerized System Validation Leadership

Regulatory Compliance and Quality Assurance

Cross Functional Collaboration and Stakeholder Engagement

Team Management & Development

Audit & Inspection Support

Qualifications

$89000 - $148000 a year

bonus

We may use artificial intelligence (AI) tools to support parts of the hiring process such as reviewing applications analyzing resumes or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed please contact us.

Required Experience :

Manager

Key Skills

Python,SOC,Debugging,C / C++,FDA Regulations,Minitab,Technical Writing,GAMP,OS Kernels,Perl,cGMP,Manufacturing

Employment Type : Full-Time

Experience : years

Vacancy : 1