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Regional Head of Commercial Quality

The Position

 

The Head of Commercial Quality is responsible for the implementation and maintenance of a regional Quality Management System (QMS) for GMP/GDP (Good Manufacturing Practices / Good Distribution Practices) and all health-regulated activities (Human Pharma & Animal Health), ensuring that all relevant external and internal requirements (e.g., Boehringer Ingelheim Policies and Procedures) are implemented, monitored for performance and adherence, and continuously improved. Compliance with all regulatory requirements is a critical success factor for the commercial supply of products to customers.

 

The Head of Commercial Quality will be responsible for setting and driving the Commercial Quality Strategy for the Region together with the respective management across different Subregions (Operating Units-OPUs). In addition, the role drives the implementation of the company Quality Management System (QMS) across different OPUs by providing continuous guidance to Commercial Quality Heads/Managers and ensuring oversight through self-inspections and risk assessments.

 

The role oversees high-level quality activities, including inspection management, vendor selection and qualification, training governance, quality KPIs, and risk management, ensuring effectiveness and continuous improvement.

 

Furthermore, The Head of Commercial Quality is responsible for setting and driving the process for proper implementation and follow-up of COIA (Corporate Division Internal Audits) across the region and for leading OPUs in the implementation of commercial quality processes, fostering strong cross-functional relationships, driving alignment and synergies across different countries, and ensuring appropriate oversight of local quality operations.

 

Tasks and Responsibilities

  • Manage the Commercial Quality unit in alignment with corporate strategy, based on the principles, targets, and strategies of the Business Centers and the approved budget.
  • Ensure effective interfaces with other functions (e.g., Regulatory Affairs, Medicine, IT, Compliance, Legal, Sales) are established and maintained.
  • Support the management of authority inspections.
  • Oversee the budget for quality cost centers.
  • Responsible for setting and shaping up the Commercial Quality Organization in Selection and hiring of the team members of the commercial quality organization.
  • Identify, develop, and manage talent within the team, including performance and development discussions.
  • Accountable for the implementation and development of the regional/local Quality Management System (QMS).
  • Ensure continuous improvement of processes and working steps along the responsible process chain and interfaces. 
  • Challenge the status quo, KPIs, and processes to optimize performance and daily operations.
  • Ensure that an effective Deviation and CAPA system is implemented and maintained.
  • Escalate quality issues related to products, outsourced services, or personnel, as appropriate.
  • Act as or serve as liaison with the Local Pharmaceutical Complaint Officer (LPCO).
  • Act as main contact partner for quality aspects regarding follow-up activities of confirmed counterfeits.
  • Evaluate product-related quality defects and act as regional MSO for Latin America (LAC), providing guidance and support for all cases.
  • Provide relevant information to local health authorities.
  • Ensure that the local QA for CSV & C (Computer Systems Validation & Compliance) during project and operational use of IT systems supporting GxP relevant processes within Operations is well established.
  • Review and approve validation documentation for local IT systems and client site systems, where applicable for global systems.
  • Ensure the setup and maintenance of a document management system for local/regional working instructions (archiving, distribution, access, revision).
  • Identify and address training needs.
  • Maintain a library of all relevant regulations and guidelines related to commercial product supply and distribution.
  • Manage corporate audits and inspections by local authorities.

 

 

Requirements

  • Demonstrated experience in team management.
  • Expertise in Quality system design and implementation in the pharmaceutical Industry.
  • Extensive experience in a GxP-regulated environment (minimum 10 years), with strong knowledge of GMP/GDP and regulatory compliance requirements.
  • Expertise in manufacturing and distribution processes.
  • Strong interpersonal and communication skills, with the ability to act as a trusted team player.
  • Proven ability to influence stakeholders across all levels of the organization.
  • Significant knowledge of risk management principles and tools.  
  • Advanced English.

 

 

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