**Job Title:** Computer System Validation & Data Integrity Lead
We are seeking an experienced professional to lead our Computer System Validation (CSV) and Data Integrity (DI) efforts in a pharmaceutical manufacturing environment.
The successful candidate will provide direction on CSV & DI best practices, applying science-based risk management approaches. They will oversee multiple ongoing projects, manage internal and external resources, ensure quality and regulatory compliance of project deliverables, drive change management initiatives, and mentor and coach Local Process Owners to elevate knowledge and adherence to industry standards.
Responsibilities:
* Provide expertise in CSV and data integrity
* Manage ongoing projects and resources
* Ensure quality and regulatory compliance
* Drive change management initiatives
* Mentor and coach Local Process Owners
Requirements:
* Strong expertise in CSV and data integrity in a pharmaceutical manufacturing environment
* Experience with API settings, DeltaV, PI, PCS7, and alarm management best practices
* In-depth knowledge of FDA and EMA expectations on CSV and DI, including risk-based validation approaches and documentation
* Excellent project management skills, including planning, organizing, and coordinating
* Demonstrated ability to lead teams in complex and fast-paced environments
* Skilled in coaching, change management, and training
* Able to navigate across multiple organizational levels and influence without direct authority
* Language requirements: English (required), Dutch (preferred)
What We Offer:
* A strategic and high-impact role within a global pharmaceutical environment
* Dynamic and multidisciplinary project work
* Competitive compensation package
* Opportunity to make a lasting contribution to compliance, quality, and innovation