Quality Supply Chain Lead
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 Kingston is hiring a Quality Supply Chain Lead. This individual will be 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.
- Oversees the supplier qualification and re-evaluation for PerMed suppliers;
- Follow up on Supplier Corrective Action responses and supplier change notification.
- Trend supplier related KPI’s
- Assess supplier quality risk assessment and support/conduct supplier audit.
- Co-ordinate with Global Supplier Quality Team for audits/ qualifications
- Review supplier quality agreements
- Product Safety:
- Ensure compliance with national and international regulations and chemicals legislation;
- Chemical regulatory monitoring for early detection of risks and deriving Lonza-specific strategies and actions.
- Creation of product specific information and documents.
Internal Auditor Leader
- Lead the internal audit process as independent auditor to the QMS.
- Host customer/client audit and trainings.
- Direct involvement and interface with internal and external auditors, including clients/notified bodies, relating to all activities, reports and files associated with Quality System.
- Liaise with conformity assessment bodies on maintenance of EMC/Safety certifications.
- Supports maintenance of regulatory files, drug master files, technical files, conformity assessment files, and country specific files.
- Demonstrates 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.
- Informs the Head of Quality and Executive Management of progress and issues.
- Develops and maintains Quality System procedures that are compliant with FDA 21 CFR 820, ISO 13485, ISO 9001 and other regulatory /client requirements.
- Train and develop of employees on quality topics.
- Works with other departments to establish and maintain appropriate standards, guidelines and quality criteria.
- Minimum 5-year management experience in a regulated industry
- University Degree or College Diploma
- 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
- Will be 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.
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.