Quality Specialist - QA Qualification

Quality Specialist, QA Qualification

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 Quality Assurance team and play a critical role in ensuring the compliance, qualification, and validation of equipment and computerized systems used in pharmaceutical manufacturing. This is an exciting opportunity to influence global engineering projects, uphold regulatory excellence, and help deliver medicines that improve lives around the world.

What you will get:

• An agile career and dynamic working culture.
• An inclusive and ethical workplace.
• Compensation programs that recognize high performance.
• Opportunities to contribute to global projects and cross-functional initiatives.
• Career development through exposure to engineering, quality, validation, and regulatory disciplines.
• A variety of benefits dependent on role and location.

What you will do:

• Provide Quality Assurance oversight for qualification and validation activities associated with equipment and computerized systems used in cGMP manufacturing environments.
• Act as the QA representative on cross-functional project teams, ensuring GMP compliance throughout all project phases.
• Review and approve commissioning, qualification, validation protocols, reports, risk assessments, and technical documentation.
• Partner closely with Global Engineering, Commissioning & Qualification (C&Q), Computer System Validation (CSV), and Quality teams to align quality standards and best practices.
• Assess new and evolving regulatory requirements and translate them into practical quality and compliance improvements.
• Support regulatory inspections, customer audits, process qualification activities, and responses to regulatory inquiries.
• Drive data integrity and continuous improvement initiatives in line with Lonza policies, industry standards, and global GMP regulations.

What we are looking for:

• Experience within Quality Assurance, qualification, commissioning, validation, or compliance activities in a GMP-regulated pharmaceutical, biotechnology, or life sciences environment.
• Understanding of qualification and validation processes for equipment and computerized systems.
• Knowledge of cGMP principles and applicable regulatory requirements, including FDA, EU GMP, and other global regulatory expectations.
• Ability to review technical documentation, assess risks, and provide quality guidance to cross-functional stakeholders.
• Strong communication and collaboration skills, with the ability to influence and build relationships across global teams.
• Bachelor's degree (Biological, Chemical, Bioprocess, or related discipline) or a comparable scientific field preferred.
• Business-fluent English and a continuous improvement mindset with a commitment to quality, compliance, and patient safety.

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.