Global Head of Distribution & In-Market Quality

Organon LLC; Luzern; On-site; CHF 180,000 - 250,000; Full time

Job summary

Organon seeks a Distribution & In-Market Quality Lead to manage a global team of quality professionals across ~45 countries, ensuring cGDP and cGMP compliance for pharmaceutical products and medical devices. The role ensures quality systems are established and maintained, with effective oversight of local regulatory requirements and global standards.

Reporting to the Head of Quality, you will shape strategy, lead budget processes, drive performance management, and collaborate across functions to

Qualifications

• Bachelor or Master degree in Chemistry, Pharmacy, Biology, Microbiology, Chemical Engineering (or equivalent).
• Solid knowledge of global cGDPs/GMPs relevant to Marketing Authorization Holders and countries in scope.
• Strong compliance mindset, excellent project management and organizational skills.
• Excellent problem solving skills, based on science, facts, data and understanding of regulatory requirements in complex and evolving environments; must be able to apply sound risk management principles.
• Ability to be decisive and influence management with demonstrated leadership skills to drive change.
• Ability to work collaboratively in team settings, across functions, and within matrix organisations to achieve objectives.
• Strong commitment to diversity and employee development.
• Strong demonstrated interpersonal, communication, collaborative and leadership skills in dealing with a broad variety of cultures.
• Demonstrated ability to create simplicity out of complex environments and challenges.
• Minimum of 15 year's experience in the pharmaceutical industry, with solid compliance experience.
• Must have expertise and broad experience in Quality Systems, Quality Assurance and Quality Control including solid knowledge of global cGDP, cGMP and regulatory requirements.

Responsibilities

• Leads the Distribution & In-Market Qualtiy organization globally.
• Oversees strategy, leadership, and budget controls for a multi-cultural quality team.
• Executes Employee Development Plan discussions and performance management.
• Contributes to DIMQ budget development and expense tracking.
• Demonstrates Organon Leadership Behaviors and leads by example.
• Collaborates with other functions to improve quality management and systems.
• Ensures alignment with global GDP/GMP/MD regulations and agency expectations.
• Establishes partnerships with global colleagues impacting Quality and Compliance.
• Implements new/revised QMS policies, standards and SOPs.
• Monitors compliance and supports continuous quality improvements.
• Communicates issues impacting Quality and Compliance.
• Provides leadership for significant investigations, fact findings, HA notifications, and market actions.

Skills

Leadership

Project management

Regulatory knowledge

Problem solving

Communication

Teamwork

Decision making

Diversity & development

Education

Bachelor or Master degree in a relevant field

Job description

Organon seeks a Distribution & In-Market Quality Lead to manage a global team of quality professionals across ~45 countries, ensuring cGDP and cGMP compliance for pharmaceutical products and medical devices. The role ensures quality systems are established and maintained, with effective oversight of local regulatory requirements and global standards.

Reporting to the Head of Quality, you will shape strategy, lead budget processes, drive performance management, and collaborate across functions to