Supplier Quality Manager (Biotech)
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of.
The Supplier Quality Manager will ensure the uninterrupted supply of materials and services to Lonza by assessing the quality of the Suppliers and their ability to meet defined requirements utilizing tools such as Quality Risk Management (QRM), supplier assessment/audit, change management, and complaint/deviation trend management.
Key Responsibilities:
- Assure new regional supplier site introductions/deactivations, site transfers and new technology introductions are performed with integrity and in full compliance to regulatory guidelines, corporate policies and procedures.
- Execute an annual auditing/assessment program to schedule, participate in and/or lead audits, manage action plans and follow up on agreed upon CAPAs.
- Assure issues are timely classified, communicated to the supplier and to Lonza Sites.
- Notify and escalate to Regional Head Global Supplier Quality any potential quality or regulatory issues that may affect product quality or regulatory compliance.
- Ensure troubleshooting and resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.
- Provide solutions to complex manufacturing, quality and negotiation problems.
- Personally lead quality audits at key supplier sites to review entire production processes related to manufacturing or testing to identify improvement opportunities.
- Provide training and leadership to members of the team.
- Participate in the Reporting on QA Supplier performance - this is to include Risk Assessment ranking and managing of defined KPI's. Monitor Key Performance Indicators and ensure work is performed in a consistent manner against harmonized expectations.
- Initiate corrective actions when necessary and perform follow-up on resulting measures.
- Support Lonza QMS and SOPs for Global Supplier Quality as assigned.
- Responsible for mitigating quality trends and driving continuous improvement for processes and product quality performance for assigned suppliers.
- Support Regional Head to find solutions to complex manufacturing, quality and negotiation problems.
Key Requirements:
- University/academy degree in Life Sciences
- Substantial experience in the pharmaceutical, biopharmaceutical or related industry
- Extensive auditing experience, including preferably auditor certification by an industry recognized body e.g. ASQ
- Profound knowledge in cGMPs requirements and understanding of regulatory requirements
- Proven track record with FDA, EMEA and other Health Authorities
- Extensive auditing experience
- Experience in Supplier Qualification and Supplier Monitoring
- Strong understanding of risk assessment and risk management fundamentals/tools
- Ability to interpret and relate Quality standards to make sound quality decisions.
- Demonstrated coaching and mentoring skills.
- Definitive and authoritative decision making ability.
- Excellent interpersonal, negotiation and communication skills in English.
- Ability to travel, up to 50%
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
