Director of Quality Assurance (Pharmaceutical, Valby)

Job summary

The role involves leading global quality oversight for Contract Manufacturing Organizations (CMOs) within the pharmaceutical sector. The Director of QA External Manufacturing will enhance governance, develop scalable quality processes, and ensure compliance to support business growth.

Qualifications

• Extensive leadership experience with a strong execution mindset in complex environments.
• Significant experience with CMOs and external manufacturing.
• Deep knowledge of GMP and pharmaceutical manufacturing throughout the product lifecycle.
• Proven track record in building governance models and Quality Systems in External Manufacturing.
• Experience in developing high-performing teams and managing stakeholder relationships.
• Strong business acumen balancing compliance, patient safety, and operational performance.

Responsibilities

• Lead and develop the QA External Manufacturing team.
• Strengthen the QA governance model for CMOs with clear accountability and oversight.
• Develop efficient processes to support a growing global CMO network.
• Manage day-to-day QA operations, ensuring timely batch release and effective handling of deviations.
• Drive continuous improvement of Quality Systems and risk management across external manufacturing.
• Build strategic partnerships with CMOs focused on collaboration and accountability.
• Support new product introductions and technology transfers.
• Manage quality risks and critical quality issues effectively.
• Ensure compliance with global GMP requirements and regulatory expectations.

Skills

• Leadership and team development.
• Strategic thinking and operational management.
• Strong communication and relationship-building skills.

Education

• Relevant degree in a scientific or engineering discipline preferred.

Tools

• Familiarity with quality management systems and regulatory compliance tools.