Oorspronkelijke vacature omschrijving:

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.

The QA Asset Head (m/f/d) leads a team of quality assurance professionals to carry out variety of quality assurance tasks related to project start up, technology transfer, clinical and commercial manufacturing which enables compliant release of product as an end result.

This role represents the Quality Organization end to end as a QA partner within an asset organization, by partnering, connecting and including other QA functions at site internal meetings, as well as client meetings, serving as the primary QA counterpart for the Manufacturing Asset Head.

The QA Asset Head (m/f/d) is instrumental in achieving this goal through team development, development of the team goals, their training, daily and strategical management of team assignments. He/ She defines and sets the model for superior customer service and ensures tactical and strategical end to end planning, through visualization and execution of QA Asset deliverables, as well as resolution of quality issues in a compliant manner.

Key responsibilities:

• Provides general leadership, guidance and support to the Quality Assurance team, as well as indirectly for quality assurance topics to the site, including to internal and external customers during project start up, technical transfer, clinical manufacture, PPQ and commercial phase of projects
• Ensures staff is meeting QA objectives and deliverables on time and in-full
• Conducts objective setting and regularly scheduled sessions with individuals of the team to review objectives, provide feedback and provide guidance for personnel advancement
• Enables training of the team for their development, and leads them in the identification and resolution of Quality issues, ensuring the necessary supporting documentation is generated
• Leads the process for risk assessment of any unplanned events and searches for effective, efficient, and cGMP compliant solutions
• Manages Operational tasks which includes but are not limited to documentation approval, alignment of QA agreements, review and approval of master batch records (blank & executed), lot disposition/ product release, production /QC operational SOP approvals, active contribution for routine production/QC issues, QA on the shop floor, deviations, change controls, CAPAs, regulatory compliance issues, batch issuance, inspection readiness, risk assessments

Key requirements:

• Bachelor or Master degree in Science, Biotechnology or related discipline
• Sound experience in the GMP regulated pharmaceutical industry in QA or Operations role as well as strong experience in the area of process improvement
• Experience of line managing a team, able to take ownership of team performance and ensure that work is allocated and scheduled appropriately, planning and prioritising effectively and problem-solving obstacles to enable the whole team to consistently delivery
• Demonstrated leadership experience and the ability to act effectively as coach and mentor in motivating your team to deliver exceptional performance
• Fluency in English

Structured, focused and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive

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.