QA Specialist V - Quality Risk Management (QRM)Location: Portsmouth, New Hampshire, USAAt 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.
What you will get- 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.
What you will do- 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.
What we are looking for- 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.
