Supplier Quality Lead (Contingent Worker - 12 months)
Today, Lonza is a global leader in life sciences operating across three continents. 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.
Lonza has an opening for a Supplier Quality Lead (Contingent Worker) to join the team on a 12 month assignment in Kingston, ON. The Supplier Quality Lead (SQL) is responsible for establishing processes and developing relationships with suppliers to ensure that received products are free of defects. The SQL troubleshoots quality issues, assesses supplier risks, analyzes defect trends, and leads continuous improvement projects to increase the supplier capability of consistently meeting Lonza requirements.
In addition, the SQL acts as an independent Internal Auditor Leader for Personalized Medicine (PerMed) Lonza Quality System and liaises with conformity assessment bodies and regulatory bodies on maintenance of EMC/Safety certifications.
- Lead investigation of supplier-related issues, and ensure that nonconforming materials and root causes are addressed.
- Oversee the qualification of processes performed by the supplier; troubleshoot and lead corrective actions relating to supplier processes.
- Assess supplier quality risk assessment and support/conduct supplier audit.
Internal Auditor Leader
- Host customer’s audit.
- Direct involvement and interface with internal and external auditors, including clients/notified bodies, relating to all activities, reports, and files associated with Quality System.
- Lead the internal audit process as an independent auditor to the QMS.
- Liaise with conformity assessment bodies and regulatory bodies on maintenance of EMC/Safety certifications.
- Maintain regulatory files, drug master files, technical files, conformity assessment files, and country-specific files.
- Demonstrate knowledge of and supports the Company’s mission, vision, value statements, standards, policies and procedures, operating instructions, confidentiality standards, and the code of ethical behavior.
- Inform the Head of Quality and Executive Management of progress and issues.
- Develop and maintains Quality System procedures compliant with FDA 21 CFR 820, ISO 13485, ISO 9001, and other regulatory /client requirements.
- Train and development of employees on quality topics.
- Work with other departments to establish and maintain appropriate standards, guidelines, and quality criteria.
- University degree or College Diploma in Engineering, Science or Quality Management
- Lead Auditor, Project Management or Lean Six Sigma (ASQ Certification)
- Certified Quality Engineer (CQE) (ASQ Certification) a plus
- Significant quality experience in a regulated industry
- Ability to problem solve and troubleshoot.
- Strong computer skills and proficiency in written and verbal communication.
- Thorough knowledge of cGMP/GLP /ISO 13485/ US FDA 21 CFR 820/ EU Directives/ ICH 9/ ICH 10.
- Must be able to work in a team environment and have good interpersonal skills.
- Experience in working on the shop floor as well as in the office.
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
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.