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 Quality Compliance Manager will be leading a small team for planning, organizing, controlling, evaluating and coordinating the implementation of Quality Compliance & Customer Management, Quality System Management, Quality Validation Management, and Quality Supplier Management as per regulations and policies in GMP standard and ISO management system, with the aim of optimizing product quality in line with company objectives.Key responsibilities:
- Manage the activities performance of compliance customer management function in order to ensure all customer & consumer issues/complaint being handled according to corporate standard
- Manage and lead customers audits, regulatory audits, religious audits (MUI, Kosher) and internal audit as GMP, ISO requirement as well as from Global Quality Lonza
- Supervise implementation of quality system within plant operation & product distribution including ISO, GMP, HALAL, BPOM according to corporate standard quality & procedure.
- Manage Quality Management System (GMP, ISO 9001:2015) and regulatory & certification for National and International standard
- Manage deviation and ensure that root cause is identified and proper actions are taken
- Control and ensure implementation on CAPAs and evaluate its effectiveness.
- Monitor validation initiatives to ensure compliance, standard quality system and support production process.
- Control and ensure all equipment, computerized systems, utilities are qualified before used and properly maintained qualification and validation status as per Validation Life Cycle.
- Control and ensure the production process, cleaning process, analytical methods in the production area are validated and properly maintained qualification and validation status as per the Validation Life Cycle.
- Evaluate and organize protocols (IQ, OQ, PQ) regarding equipment, computerized systems, and utilities, as well as production process, cleaning process and analysis method as per compliance requirements before validation process.
- Evaluate reports related validation and qualifications timely and ensure that non-conformities that occur against the stipulated requirements are investigated and justified.
- Develop budget in Quality Compliance and manage its realization properly in order to ensure internal budget control.
- Bachelor degree in Pharmacy or Engineering studies (Industrial Engineering, Chemical Engineering, or Management)
- Experience in site based GMP manufacturing or quality operations roles
- Significant line management or supervisory experience
- Action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, and analytical thinking
- Fluent in English
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.