At Lonza, we invest in great people. We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success.
Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia.
Our vision :
We strive to be the leading supplier using science and technology to improve the quality of life.
Our mission :
We work with passion, using advanced technologies, to transform life science into new possibilities for our customers.
Do you want to help us as we shape the future of this great organization?
Job Description Summary
For Ibex® Solutions (www.ibex.lonza.com), 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 Group Leader Drug Product Ibex®.
The QA Group Leader Drug Product Ibex® will form a team of QA managers / specialists. He / she implements Quality Assurance capabilities that positively impact the quality strategy of the company.
He / she will be accountable for the performance and results of the assigned area. As a QA Group Leader, he / she will be a member of the Ibex® QA Leadership Team.
Key accountabilities and duties
Manage all Quality and Compliance drug product related activities of the Ibex® site covering different technologies.
Responsible that all manufacturing processes are executed on qualified equipment and validated processes.
Setting up / managing a team of QA managers / specialists. Provides leadership to the team with responsibility for all aspects of human resource management such as qualification, development, coaching and hiring,
Act as deputy of the Responsible Person (FvP : Fachtechnisch verantwortliche Person).
Support the development of the overall quality strategy for Ibex®.
Partner with Operations Ibex to ensure alignment of Manufacturing and Support Functions in executing the strategy.
Act as SME for Quality / GMP compliance at the site.
Trains and supervises staff and works cooperatively with Ibex leadership to achieve quality and compliance goals.
He / she supports continuous improvements programs to establish an effective Quality Management System.
Ensure that primary responsibilities of QA are executed in line with corporate requirements, industry best practices and current regulatory requirements (cGMPs).
Responsible for resource planning of the assigned team members with regard to the fulfillment of all production orders.
Implements the Lonza culture via openness for change and new ideas, cooperative teamwork and continuous improvement even outside his / her own area of responsibility.
Implements a vision as important contributor to the organizations success.
Ensures a thorough information exchange from other management levels to his / her team and the other way around through regularly team meetings and escalation of production issues.
Ensures and manages the respective interfaces to the Manufacturing teams, QC, Support Functions, Project- and Site Engineering.
Qualification and Skills required
Master degree or PhD in pharmacy, biotechnology, life science or related field.
More than 7 years of experience in the cGMP regulated pharmaceutical industry, preferably in a quality and compliance role in aseptic filling / sterile production.
Strong background in cGMPs is an asset.
Strong leadership skills; very good communication skills and interaction with all kind of interfaces within the organization, customers and with health authorities (Swissmedic, FDA etc.).
Strong team orientation.
Structured, focused and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive.
Sound experience in representing Quality and Compliance in the operational manufacturing environment.