Quality Expert, QA Qualification

Join our Global Quality Assurance team and play a key role in shaping quality strategy for qualification and validation activities across Lonza's global engineering network. This senior-level position offers the opportunity to influence major pharmaceutical manufacturing projects, provide expert regulatory guidance, and drive compliance excellence across equipment, facilities, utilities, and computerized systems.

About Lonza

• San Jose, Costa Rica Every day, our teams across the world work together to turn scientific breakthroughs into life-changing medicines that reach up to 100 million patients a year.
• Lonza is a place where people can make a unique impact, grow their careers and belong.
• We are a place of unique opportunity, where your ideas, expertise and ambition can make a real difference.
• Here, you will have the freedom to grow, the support to succeed and the chance to contribute to work that matters.
• We are the makers of the medicines of tomorrow.
• Join us.
• Be you.
• Apply now.

Responsibilities

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

Requirements

• Significant experience within Quality Assurance, qualification, validation, commissioning, or compliance functions in the pharmaceutical, biotechnology, or life sciences industry.
• Strong expertise in cGMP requirements and global regulatory expectations, including FDA, EU GMP, and other international health authority standards.
• Demonstrated experience supporting qualification and validation of equipment and computerized systems within regulated manufacturing environments.
• Ability to provide strategic quality guidance and influence decisions across cross-functional and global stakeholder groups.
• Strong knowledge of risk management, data integrity, validation lifecycle principles, and quality systems.
• Bachelor’s in engineering, Biological Sciences, Chemical Sciences, Biotechnology, or relevant experience.
• Business-fluent English with exceptional communication, collaboration, and problem-solving skills.
• You will feel at home at Lonza if you: Take ownership, step forward, and enjoy meaningful responsibility.
• Love solving problems and thrive in a complex, fast-moving environment.
• Are curious, always looking to learn and improve.
• Work collaboratively, contributing to something bigger than yourself.
• Are motivated to make a difference through work that impacts customers and their patients.

Benefits

• An agile career and dynamic working culture.
• An inclusive and ethical workplace.
• Compensation programs that recognize high performance.
• Opportunities to act as a subject matter expert on high-impact global projects.
• Exposure to cross-functional leadership and strategic decision-making across engineering and quality organizations.
• Continuous professional development within a global pharmaceutical manufacturing environment.
• A variety of benefits dependent on role and location.