QA Specialist V-Quality Risk Management
About The Position
QA Specialist V - Quality Risk Management (QRM) at Lonza helps strengthen the site-wide quality culture and supports risk-based decision-making. In this highly visible role, the specialist leads cross-functional risk assessments, maintains the site's Quality Risk Management framework, and partners with teams across the business to drive continuous improvement and regulatory compliance. Working closely with Manufacturing, Quality Control, Engineering, and Technical Operations teams, this role plays a key part in identifying, evaluating, and mitigating quality and operational risks that support the delivery of life-changing therapies.
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.
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.
Benefits
- Medical, dental, and vision insurance.
- Compensation programs that recognize high performance.
- Opportunities for professional growth and ongoing development.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
