QA Specialist V-Quality Risk Management

Location: Portsmouth, New Hampshire, USA

About the role

At Lonza, we are looking for a QA Specialist V - Quality Risk Management (QRM) to help strengthen our site-wide quality culture and support risk-based decision-making. In this highly visible role, you will lead cross-functional risk assessments, maintain the site's Quality Risk Management framework, and partner with teams across the business to drive continuous improvement and regulatory compliance. Working closely with Manufacturing, Quality Control, Engineering, and Technical Operations teams, you will play a key role in identifying, evaluating, and mitigating quality and operational risks that support the delivery of life-changing therapies.

Responsibilities

• Lead cross-functional quality risk assessments and facilitate risk-based decision making.
• Provide quality risk management expertise to support site projects and initiatives.
• Maintain and improve site risk registers and governance processes.
• Develop, deliver, and continuously improve QRM training programs.
• Support audits, inspections, and regulatory readiness activities.
• Review risk assessments and ensure compliance with site procedures.
• Drive continuous improvement of the site's Quality Risk Management program.

Requirements

• Bachelor's degree in Life Sciences or a related field.
• Experience working in a GMP-regulated environment.
• Knowledge of Quality Risk Management principles and risk assessment methodologies.
• Strong analytical, problem-solving, and decision-making skills.
• Excellent communication and facilitation skills.
• Ability to manage multiple priorities and deliver results independently.
• Strong collaboration and stakeholder management capabilities.

Benefits

• An agile career and dynamic working culture.
• The opportunity to influence site-wide quality and risk management strategies.
• Exposure to cross-functional teams and senior stakeholders.
• An inclusive and ethical workplace.
• Opportunities for professional growth and ongoing development.
• Compensation programs that recognize high performance.
• Medical, dental, and vision insurance.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone's ideas, big or small, have the potential to improve millions of lives, and that's the kind of work we want you to be part of.