Head of Quality Control, MM
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 is 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 Head of Quality Control (QC) is responsible for Quality Control activities which may include biochemistry, microbiology, environmental monitoring, raw materials, stability, method transfer, instrument and software qualification, data integrity, sample management, and QC document management.
The Head of QC will provide a safe, controlled work environment in all areas of responsibility while being aware of the site safety objectives and making sure these are communicated and understood by all staff. Provides guidance to supervisors and other frontline leads to achieve goals in accordance with established policies. Establishes and recommends changes to policies which affect subordinate organizations. Develops and administers budgets, schedules and performance requirements.
Role will be responsible for operational excellence and innovation as well QC financial targets, to ensure stable planning of QC activities as per site needs. Responsible for people development and growth.
- Lead the Quality Control Department for the Mammalian Business Unit at Lonza Tuas with responsibility for the following groups within the department: Raw Material, Analytical, Biochemistry, Microbiology, Environmental Monitoring, Assay validation/transfer, laboratory information and sample logistics.
- Responsible for providing support to the QC Department of the Cell & Gene Therapies Business Unit for certain shared services including Raw Materials, QC Systems, Sample Logistics etc.
- Responsible for the development and implementation of a Quality Control strategy to meet business goals.
- Responsible to ensure the QC operations comply to cGMP and safety regulations.
- Responsible to ensure QC participation in the multidisciplinary customer teams (IPT, JPT) and the global QC work teams.
- To evaluate and prioritize QC projects in the medium and long term, ensuring that the human, technical and financial resources are focused on the achievement of strategic objectives.
- To lead the development and implementation of improvement systems in the area in line with the Operational Excellence strategy.
- Plan resources for QC to support projects and testing in alignment with production activities.
- To lead the method transfer activities for customer projects in Quality Control.
- To lead from a QC standpoint audits/inspections by customers and/or regulatory agencies.
- To ensure the development and coaching of QC staff in order to improve their performance, abilities and competences.
- Drive the timely release of test results and approval of certificate of Analysis to support batch release.
- Ensure collaboration between QC and all other functions.
- Any other duties as assigned by your Supervisor/ Manager.
- Masters/Bachelor Degree in a Science related discipline.
- Significant years of relevant work experience in a highly regulated operational environment with at least 5 years in a managerial capacity within pharmaceutical operations.
- Practical experience of cGMP operations; FDA/EMEA exposure is a must.
- Excellent leadership skills in team based management.
- Strong communication and interpersonal skills.
- Significant experience in financial control in a production environment.
- Strong understanding of continuous improvement strategies and tools, including Lean Laboratories.
- Skillful knowledge of Microsoft Windows and Microsoft Office (Excel, Word, Project, PowerPoint).
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 achieve 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.