Quality Expert - QA Qualification

Quality Expert, QA Qualification

Location: 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.

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.

What you will get:

• 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.

What you will do:

• 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.

What we are looking for:

• 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.

Why Lonza:

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.