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Regional Head of Commercial Quality

Boehringer Ingelheim · Région métropolitaine de Buenos Aires

🇬🇧 English
GMP GDP Quality Management System (QMS) CAPA Risk assessment Internal audit

Job description

About the role

The Regional Head of Commercial Quality is responsible for implementing and maintaining a regional Quality Management System (QMS) for GMP/GDP activities in human pharma and animal health. The role ensures compliance with all external and internal regulatory requirements and drives continuous improvement across the region.

Key responsibilities

  • Define and execute the Commercial Quality strategy for the region in collaboration with sub‑regional management.
  • Oversee the implementation of the corporate QMS across operating units, providing guidance to Commercial Quality heads and managers.
  • Manage high‑level quality activities such as inspection management, vendor selection and qualification, training governance, quality KPIs and risk management.
  • Lead the process for Corporate Division Internal Audits (COIA) and ensure follow‑up actions are completed.
  • Maintain effective interfaces with Regulatory Affairs, Medicine, IT, Compliance, Legal and Sales.
  • Support authority inspections and oversee the quality budget.
  • Recruit, develop and retain talent within the Commercial Quality organization.
  • Ensure a robust Deviation and CAPA system, and escalate quality issues as needed.

Required profile

  • Proven experience leading a commercial quality function in a regulated pharmaceutical or animal health environment.
  • Strong track record of managing cross‑functional teams and driving strategic initiatives.
  • Experience with budget responsibility and talent management, including hiring and performance development.
  • Ability to challenge the status quo, optimise processes and ensure continuous improvement.
  • Excellent communication skills to liaise with internal stakeholders and external authorities.

Required skills

  • GMP (Good Manufacturing Practices)
  • GDP (Good Distribution Practices)
  • Quality Management System (QMS) implementation
  • CAPA (Corrective and Preventive Action) management
  • Risk assessment and mitigation
  • Internal audit procedures

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Published 4 months ago

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Boehringer Ingelheim

Région métropolitaine de Buenos Aires