Senior Validation Lead

We are seeking an experienced Computer Systems Validation (CSV) Specialist with 7+ years of hands-on CSV experience in the biopharmaceutical industry. The ideal candidate will provide technical leadership across the computer system lifecycle, including validation, maintenance, data migration, and decommissioning, while ensuring compliance with GMP, data integrity, and regulatory requirements.

Required Qualifications

• 7+ years of hands-on Computer Systems Validation (CSV) experience.
• Strong technical leadership and project execution skills.
• Recent experience in the biopharmaceutical industry.
• Proven experience supporting FDA and EMA regulatory inspections and maintaining inspection readiness.
• Hands-on experience with data migration planning, testing, execution, and reporting.
• Strong knowledge of data integrity requirements, controls, documentation, evidence, and reporting.
• Experience with infrastructure qualification and risk-based validation approaches.
• Ability to lead technical discussions on CSV strategies, methodologies, and validation deliverables.
• Experience mentoring and educating IT staff with limited GxP knowledge.
• Willingness to travel frequently to site locations as required.

Key Responsibilities

• Lead CSV strategies and execution across ERP, data warehousing, laboratory, manufacturing, and other GxP software systems.
• Establish and maintain the CSV Center of Excellence (CoE) and Community of Practice (CoP).
• Develop and maintain CSV and Data Integrity policies, standards, SOPs, templates, and risk-based validation approaches, including Computer Software Assurance (CSA).
• Provide CSV subject matter expertise and technical leadership to project implementation teams and IT personnel supporting GxP applications.
• Build and maintain a strong network of subject matter experts across IT, laboratory, and manufacturing functions.
• Develop and implement compliance frameworks and dashboards to proactively monitor compliance and address potential risks.
• Support inspection readiness and ensure ongoing adherence to applicable regulatory requirements and quality standards.
• Drive continuous improvement in CSV practices, compliance processes, and team capabilities.