CSV / Quality Manager (Senior) (Ciudad de México)

CSV / Quality Manager (Senior) (Ciudad de México)

15 ago
|
Deloitte
|
Ciudad de México

15 ago

Deloitte

Ciudad de México

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 tran

📌 CSV / Quality Manager (Senior) (Ciudad de México)
🏢 Deloitte
📍 Ciudad de México

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