Quality Expert, QA Qualification

About the role

Lonza's Global Quality Assurance team is hiring a Quality Expert for QA qualification in San Jose, Costa Rica. The senior-level position shapes quality strategy for qualification and validation activities across Lonza's global engineering network, influencing major pharmaceutical manufacturing projects and providing expert regulatory guidance on equipment, facilities, utilities and computerized systems.

Key responsibilities

• Provide Quality Assurance leadership for qualification and validation of equipment, facilities, utilities and computerized systems in cGMP environments.
• Serve as the Global QA representative on cross-functional engineering and project teams, integrating quality and compliance expectations throughout project lifecycles.
• Review and approve commissioning, qualification and validation documentation, technical assessments, risk evaluations and compliance strategies.
• Guide functional teams on commissioning, computer system validation (CSV) and enabling qualification activities.
• Translate regulatory trends, inspection observations and industry expectations into quality improvements and compliance strategies.
• Partner with Global Engineering, C&Q, CSV and Quality teams to harmonize and continuously improve global qualification standards.
• Support regulatory inspections, customer audits and process qualification while championing data integrity and GMP compliance.

Required profile

• Significant experience in QA, qualification, validation, commissioning or compliance in the pharmaceutical, biotechnology or life sciences industry.
• Bachelor's degree in engineering, biological, chemical or biotechnological sciences, or relevant experience.
• Business-fluent English with strong communication, collaboration and problem-solving skills.

Required skills

• Strong expertise in cGMP and global regulatory expectations (FDA, EU GMP and other health authorities).
• Demonstrated experience qualifying equipment and computerized systems in regulated manufacturing.
• Strategic quality guidance and influence across global stakeholders.
• Risk management, data integrity, validation lifecycle principles and quality systems.

What we offer

• An agile career and dynamic, inclusive and ethical workplace.
• Compensation programs recognizing high performance and benefits depending on role and location.
• Opportunities as a subject matter expert on global projects and exposure to cross-functional leadership.
• Continuous professional development in a global pharmaceutical manufacturing environment.