CSV / Quality Manager (Senior)

Contract Duration

18 Months | Full-Time Contract

Language Requirement

Fluent Spanish (Written and Spoken)

Role Overview

Our client seeking an experienced Senior CSV / Quality Manager to lead quality assurance and computer system validation activities within a large-scale transformation programme. The successful candidate will be responsible for ensuring that all regulated systems, processes, and project deliverables comply with applicable pharmaceutical quality standards, regulatory requirements, and internal quality frameworks.

This role requires a senior professional with extensive experience in Computer System Validation (CSV), Quality Management Systems (QMS), GxP compliance, and regulated pharmaceutical environments . The individual will provide strategic oversight of validation activities, quality governance, risk management, and compliance throughout the programme lifecycle.

Key Responsibilities

Quality Management & Governance

• Lead and oversee quality management activities across programme workstreams.
• Ensure compliance with GxP, GMP, GDP, and applicable regulatory requirements.
• Establish and maintain quality governance frameworks for programme execution.
• Drive quality risk management processes and ensure appropriate mitigation strategies are implemented.
• Support internal and external audits, inspections, and compliance reviews.

Computer System Validation (CSV)

• Lead CSV strategy, planning, and execution for regulated systems.
• Ensure validation activities adhere to industry standards and regulatory requirements.
• Review and approve validation documentation, including:
• Validation Plans
• User Requirements Specifications (URS)
• Functional Specifications
• Risk Assessments
• IQ/OQ/PQ Protocols
• Traceability Matrices
• Validation Reports
• Oversee testing activities and ensure validation evidence is complete and inspection-ready.
• Drive adoption of risk-based validation methodologies.

Transformation Programme Support

• Provide quality and validation leadership across large transformation initiatives.
• Collaborate with business, IT, quality, and vendor teams to ensure programme compliance.
• Assess project deliverables for quality and regulatory impact.
• Identify risks related to quality, compliance, and system validation and implement corrective actions.

Stakeholder Management

• Engage with senior business leaders, quality teams, project managers, and external vendors.
• Act as the key point of contact for quality and validation matters.
• Provide guidance and mentoring to validation and quality team members.
• Facilitate workshops and governance forums related to quality and compliance.

Documentation & Compliance

• Ensure all validation and quality documentation is maintained in accordance with company standards.
• Support deviation management, CAPA processes, and change control activities.
• Ensure audit readiness across all programme workstreams.
• Maintain accurate records and evidence to support regulatory inspections.

Required Qualifications & Experience

Essential

• Extensive experience in Computer System Validation (CSV) within regulated pharmaceutical or life sciences environments.
• Strong background in Quality Management Systems (QMS) and regulatory compliance.
• Proven experience overseeing validation activities within large-scale transformation programmes.
• Experience working within GxP-regulated environments.
• Strong understanding of:
• GMP
• GAMP 5
• FDA 21 CFR Part 11
• Annex 11
• Data Integrity requirements
• Experience managing quality and compliance risks across complex projects.
• Excellent stakeholder management and communication skills.
• Fluent Spanish (written and spoken).

Preferred

• Experience within global pharmaceutical manufacturing environments.
• Experience implementing or validating ERP, Manufacturing, Quality, Laboratory, or Supply Chain systems.
• Certification in Quality Management, CSV, Validation, or Project Management.
• Knowledge of digital transformation and enterprise system implementations.