CSV / CSA Manager

Are you currently considering your next opportunity? Would you be excited to join a new global team, based in Ireland, for a leading pharmaceutical company? Are you experienced in IT validation and CSA risk-based approaches? If the answers are yes, you could be the perfect candidate for this opportunity! Don't hesitate, apply today!

Job Description

Our client is seeking senior-level support to own validation strategy and portfolio planning in a core team responsible for validation activities in respect to CSV and CSA Risk Management for global projects. The successful candidate will have proven project management experience, CSV experience in IT environments, and program-level risk and issue management experience. Use of AI tools in a validation context is also advantageous.

Responsibilities

• Validation strategy across the program: risk-based approaches, test design methodology, traceability discipline, evolution of practice
• Quality oversight of validation deliverables before client SQA review
• Portfolio planning: project intake, prioritization, sequencing, capacity allocation
• Validation planning oversight: validation plan timelines, dependency tracking, milestone integrity
• Program-level risk and issue management
• Reporting: portfolio dashboard, monthly status pack, QBR materials.

Requirements

• Experience in validation of enterprise IT systems
• Strong knowledge of CSV and CSA methodologies
• Experience with risk-based testing and validation of enterprise systems
• Understanding of validation frameworks for complex IT systems is advantageous
• Flexibility to work within 10:00 - 20:00 GMT.

Benefits

• Competitive and attractive employee compensation package
• Pension contributions
• Health insurance
• Paid public holidays.

Location: Cork, Ireland | remote

Desired Skills and Experience Responsibilities

Validation strategy across the program: risk-based approaches, test design methodology, traceability discipline, evolution of practice

Quality oversight of validation deliverables before client SQA review

Portfolio planning: project intake, prioritization, sequencing, capacity allocation

Validation planning oversight: validation plan timelines, dependency tracking, milestone integrity

Program-level risk and issue management

Reporting: portfolio dashboard, monthly status pack, QBR materials.

Requirements

Experience in validation of enterprise IT systems

Strong knowledge of CSV and CSA methodologies

Experience with risk-based testing and validation of enterprise systems

Understanding of validation frameworks for complex IT systems is advantageous

Flexibility to work within 10:00 - 20:00 GMT.