Quality Assurance Qualification Manager Ibex™ Solutions
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.
For Ibex™ Solutions, our recently launched unique biological manufacturing and development concept in Visp, Switzerland, we have multiple openings. Become part of this exciting opportunity and join our team by applying for the position as QA Manager Qualification. In this role, you will be part of the QA department being responsible for the quality oversight of Commissioning&Qualification startup and routine activities of a brand new biomanufacturing unit within our Ibex™ Solutions biopark. Thereby, you will ensure that all processes for facility, equipment, utilities and systems (incl. computerized systems) qualification/ validation comply with cGMP requirements and internal/ external quality standards over the entire life cycle. As a Quality and Compliance representative, you will be a key member of a dedicated cross-functional technical project team focusing on the startup of a new biomanufacturing unit.
- Own all quality related responsibilities for the commissioning and qualification activities of dedicated facilities, equipment, utilities and systems related to the GMP biomanufacturing
- Act as representative of QA Qualification in the project organization in terms of qualification/ validation of facilities, utilities, equipment and systems
- Identify new QA relevant topics e.g. as part of project of new technologies and work actively on their development into new or already established QA strategies or standards
- Support the transfer from the project into the production phase and support the handover of the facility to Operation/ QA Operation
- Review and release Qualification Documents (URS, Qualification Plan & Report, DQ/ IQ/ OQ/ PQ Reports, etc.)
- Act as representative of QA Qualification during FATs and participate in Supplier Qualification Audits as Subject Matter Expert (SME)
- Support and approve quality risk analysis
- Represent specific areas as SME and provides guidance and recommendations in these areas to internal or external customers
- Bachelor, Master degree or PhD in Biotechnology, Chemistry, Life Science or related field
- Significant experience in the GMP regulated pharmaceutical industry; preferably in a Qualification / Validation role within the Quality Unit
- Good understanding of the applicable cGMP regulations and Guidelines (e.g. ISPE) as well as general knowledge of engineering (cGEP) and manufacturing processes (cGMP)
- Experience in interacting with regulatory agencies (Swissmedic, FDA etc.)
- Willingness to interpret and maintain proficiency in regulations, standards, guidelines and trends in cGMP manufacturing is a must
- Strong problem-solving skills and high attention to quality
- Independent decision making regarding quality and compliance
- Ability to prioritize and manage work to critical project timelines in a fast-paced environment
- Excellent communication as well as organizational and interpersonal skills
- Fluency in English, German would be an advantage
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.