Associate Department Manager, Systems QC

at  Lonza

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.
Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network.
Lead all aspects of our Quality Control (QC) team as an expert and motivated Associate Department Manager. In this pivotal role, you will coordinate core activities, including material and product testing nd the successful execution of customer projects. Your leadership will ensure operational excellence, regulatory compliance, and a high-performing team environment.

QUALIFICATIONS:

• Bachelor’s degree in a relevant scientific field or equivalent professional experience.
• A minimum of 10 years of GMP-Quality experience, with a preference for laboratory experience in the biotech or medical field.
• Proven leadership skills and a demonstrated ability to manage teams and complex projects effectively.
• Strong expertise in regulatory compliance and quality management systems.
  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

• Support and administration of all QC computerized system (system back-up, audit trail review and user access administration).
• Maintenance of LIMS static data (Sample Manager LIMS, MODA LIMS and STATISTICA systems).
• Generation and execution of computer validation documentation (protocols and reports).
• Maintenance of software-related changes to computerized instruments.
• Server and database maintenance and administration related to laboratory systems oversight and to ensure that the computer system policies and procedures are aligned with current regulatory expectations.
• Knowledge of new technologies, strong ability to balance multiple priorities, provide training for the roll-out of new computerized systems.
• Identify computer-related issues; troubleshoot and complete or coordinate deviation, change control and/ or corrective action records.
• Customer and regulatory agency interaction as the need arises.
• System/ equipment manufacturer and or vendor interaction as required in order to troubleshoot system issues.
• Available to troubleshoot and resolve critical system issues as they occur.
• Develop the growth of QC personnel by providing coaching, mentoring, and tailored training to improve technical, GMP (Good Manufacturing Practice), and leadership capabilities.
• Drive team performance by supporting the personal and professional development of direct and indirect reports.
• Ensure full GMP compliance, adherence to safety protocols, and maintain outstanding housekeeping standards within the laboratory.
• Establish, revise, and maintain QC policies and procedures to meet both regulatory and operational requirements.
• Lead inspection readiness efforts and represent the QC function during regulatory and customer audits.
• Provide ongoing mentoring and development for team members, encouraging a motivated, cohesive, and high-performing team.
• Coordinate the installation, qualification, and validation of software aspects for computerized instrumentation, including the creation and execution of validation documentation (protocols and reports).