Executive Director, Quality Site Head

About the role

Lonza is seeking an Executive Director, Quality Site Head to join the Stein site leadership team. The role provides strategic and operational quality leadership for a growing drug‑product manufacturing operation, ensuring the highest standards of product quality, patient safety, and regulatory compliance.

Key responsibilities

• Serve as the senior quality leader and trusted advisor to the Site Head and leadership team.
• Define and execute the site’s quality strategy aligned with global objectives.
• Lead all quality functions, including Quality Assurance, Quality Control, Compliance, Validation, and Quality Systems.
• Drive a proactive quality culture focused on accountability and continuous improvement.
• Oversee quality activities for drug‑product manufacturing, packaging, testing, release, and lifecycle management.
• Ensure compliance with GxP, FDA, EMA, Swissmedic, and other global regulatory standards.
• Provide expert guidance on aseptic processing, sterile manufacturing, biologics, and advanced drug‑product technologies.
• Collaborate with Manufacturing, Engineering, Supply Chain, and Technical Services to maintain robust quality oversight.
• Spend time on the shop floor (Gemba) acting as a coach.
• Develop the quality organization to support site growth from ~500 to 1,000 employees.

Required profile

• Proven senior leadership experience in quality management within drug‑product manufacturing.
• Deep knowledge of GxP requirements and regulatory expectations (FDA, EMA, Swissmedic).
• Track record of building high‑performing quality teams and driving cultural change.
• Ability to partner across manufacturing, engineering, and supply‑chain functions.

Required skills

• Aseptic processing
• Sterile manufacturing
• Biologics
• Advanced drug‑product technologies
• GxP compliance
• Quality Assurance
• Quality Control
• Validation
• Quality Systems