Quality Assurance Manager
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.
We have recently been confirmed as the global manufacturing partner for Moderna’s vaccine against the novel coronavirus, providing a tenfold manufacturing capacity increase. As other businesses face increasing economic uncertainty, we are fortunate to have opportunities for expansion. Through this new collaboration, our work will have a significant, direct and long-term impact on the management of this global pandemic.
Become part of this exciting opportunity and join our team by applying for the position as Quality Assurance Manager Ibex™. The QA Manager specifies quality requirements for manufacturing processes and ensures that manufactured products comply with national and international requirements and cGMP standards over their entire life cycle. As a Quality and Compliance representative, you will be a key member in cross-functional project teams ensuring measures for product safety, product quality & cGMP compliance are implemented.
- Own all quality related responsibilities for the manufacturing processes of biopharmaceutical products for clinical and commercial supply
- Represent QA in project/ tech transfer organizations for new biotech manufacturing processes
- Coordinate QA interests during the different project phases
- Make quality decisions for the respective projects in internal and external meetings
- Responsible for review and final release of records like Standard Operating Procedures (SOPs), Master Manufacturing Batch Records, Material Specifications, Deviations, Change Requests, Effectiveness Checks, Testing Protocols & Reports etc.
- Perform assessments for all product-related changes, assesses relevance to regulatory filings, decides to implement and provide change controls for approval to customers where required
- Support and approve project/ product specific risk assessments
- Perform internal and external audits
- Support and participate in customer audits and health authority inspections
- Ensure all deviations are appropriately investigated and recorded
- Direct the investigations of customer product complaints and assure the completion of the appropriate documentation
- Responsible to drive CAPA (Corrective and Preventive Actions) and effectiveness check items to completion and timely closing
- Ensure an efficient cGMP compliant life cycle management of all products manufactured
- Identify emerging QA relevant topics, communicates to the Ibex QA organization and work actively on their development into new or already established Quality and Compliance strategies and/ or standards
- Bachelor, Master degree or PhD in chemistry, biotechnology, life science or related field
- Significant experience in the GMP regulated pharmaceutical industry; preferable in a QA role
- Strong background in cGMP regulations
- General knowledge of manufacturing processes and analytical methods
- Auditing experience
- Experienced in the interaction with health authorities (Swissmedic, FDA etc.)
- Strong team- and solution-orientation
- Ability to oversee project execution to identify non-compliance from quality standards
- Ability to prioritize and manage work to critical project timelines in a fast-paced environment
- Structured, focused and well-organized working attitude
- Open-minded for new ideas and suggestions
- Agile, highly motivated and dynamic drive
- Excellent verbal, written and interpersonal communication skills
- Fluency in English, German would be advantageous
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.