Executive Director, Quality Site Head Stein

Lonza seeks an Executive Director and Quality Site Head in Stein, Switzerland, to lead site-wide quality operations, ensure regulatory compliance, and drive continuous improvement across Drug Product manufacturing.

This senior leadership position serves as the primary quality authority for the Stein facility, reporting directly to the site leadership team. The role is tasked with establishing strategic quality direction, overseeing all quality functions, and ensuring strict adherence to global regulatory standards while supporting significant site expansion and operational growth.

Responsibilities

• Act as the top quality authority and trusted advisor to the site leadership team.
• Develop and implement a quality strategy aligned with global objectives and business goals.
• Oversee all quality departments, including Assurance, Control, Compliance, Validation, and Systems.
• Cultivate a proactive quality mindset focused on accountability, patient safety, and ongoing improvement.
• Build a capable quality team to support site growth from roughly 500 to 1,000 staff.
• Direct quality activities for Drug Product manufacturing, packaging, testing, release, and lifecycle management.
• Ensure strict compliance with GxP, FDA, EMA, Swissmedic, and other global regulations.
• Provide expert guidance on aseptic processing, sterile manufacturing, biologics, and advanced Drug Product technologies.
• Collaborate with Manufacturing, MSAT, Engineering, Supply Chain, and Technical Services for robust quality oversight.
• Engage on the shopfloor as a coach to foster quality culture.
• Assess organizational capabilities and address competency gaps.
• Implement talent development, succession planning, and training programs.
• Attract, retain, and develop top quality talent.
• Ensure inspection readiness and maintain a robust quality management system.
• Lead regulatory inspections, customer audits, and corporate quality assessments.
• Serve as the primary quality representative during interactions with regulatory authorities and key customers.
• Oversee timely investigation, root cause analysis, and implementation of CAPAs.
• Drive continuous improvement initiatives across all quality processes.
• Promote modern quality methodologies and digital tools, including Six Sigma, Lean, FMEA, SPC, and advanced analytics.
• Manage deviations, change controls, complaints, CAPAs, risk assessments, and product quality reviews.
• Establish and monitor quality performance indicators.
• Apply science- and risk-based approaches to quality oversight.
• Anticipate and mitigate quality and compliance risks associated with site growth and new technologies.
• Ensure effective escalation and resolution of critical quality issues.
• Build strong partnerships with customers as a key quality representative.
• Collaborate with other site quality leaders and global quality teams to harmonize standards.
• Support business development, customer visits, due diligence, and new product introductions.
• Represent the site within global quality networks and industry forums.
• Monitor emerging regulatory requirements and industry trends.
• Translate industry developments into practical quality strategies.
• Champion innovation and modernization initiatives.
• Act as a visible leader internally and externally.

Requirements

• Master's degree in Pharmaceutical Sciences, Quality Management, Life Sciences, Engineering, or a related discipline.
• Several years of progressive leadership experience within pharmaceutical quality organizations.
• Many years in a senior quality leadership role with direct responsibility for site-wide quality operations.
• Demonstrated expertise in Drug Product manufacturing within a pharmaceutical, biotechnology, or CDMO environment.
• Proven track record of successfully leading regulatory inspections by FDA, EMA, Swissmedic, and other global health authorities.
• Strong understanding of biologics, sterile manufacturing, aseptic processing, and modern pharmaceutical quality systems.

Nice to have

• Advanced qualifications in quality, regulatory affairs, or business leadership.
• Experience supporting large-scale site expansions, organizational transformation, or significant operational growth.

About the company

Lonza is a global life sciences leader operating across five continents, dedicated to improving lives worldwide. The company values talented individuals who collaborate to devise innovative ideas that help businesses and positively impact millions of people. Lonza fosters an environment where employees own their careers, contribute their ideas, and work ethically to protect people and the environment. Joining Lonza offers the satisfaction of solving complex problems, developing new ideas, and making a meaningful difference in the world.

• Global leader in life sciences operating across five continents.
• Values talented people working together to devise ideas that help businesses to help people.
• Lets people own their careers and values their ideas to genuinely improve the world.
• Products and services have a positive impact on millions of people.
• Respects and protects people and the environment, achieving success ethically.
• Offers the challenge and creativity of solving complex problems and developing new ideas in life sciences.
• Provides the satisfaction of improving lives all around the world and making a meaningful difference.