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 Quality Systems Group Leader Ibex™.
The Quality Systems Group Leader Ibex™ will establish and lead a team of specialists. He / she implements Quality Systems capabilities that translate the quality strategy of the company and support the success of the assigned investment projects.
As a Quality Systems representative, he / she will be a member of the Ibex™ Quality Assurance Leadership Team.
Key accountabilities and duties
Establishes a team of Quality Systems managers / specialists. Gives leadership to the team with full responsibility for all aspects of human resource management such as qualification, development, coaching, hiring, pay decisions and discipline issues.
Manages all Quality Systems activities in multiple plants of the Ibex™ biopark covering different technologies, based on the global quality strategy.
Support the development of the overall quality strategy for Ibex™.
Partner with Operations to ensure alignment of Manufacturing and Support Functions in executing the strategy.
Maintains and monitors the processes for Document Management, Change Control, Deviation and CAPA Management.
Act as the lead SME for Quality / GMP compliance issues.
Manages the establishment of the APQRs.
Trains and supervises staff and works cooperatively with Ibex™ leadership to achieve quality and compliance goals.
Ensures that regular assessments of the compliance and effectiveness of the Quality System requirements are performed and the results are reported to the Ibex™ leadership team.
He / she champions continuous improvements efforts to establish an effective and efficient Quality Management System in compliance with cGMP guidelines and corporate requirements.
Coordinates and manages customer audits and health authority inspections (e.g. Swissmedic, FDA, etc.).
Ensure that primary responsibilities of Quality & Compliance are executed in line with corporate requirements, industry best practices and current regulatory requirements (cGMPs).
Implements the Lonza culture via openness for innovations and change, cooperative teamwork and continuous improvement even outside his / her own area of responsibility.
Supports and implements a vision as important contributor to the organizations success.
Ensures a thorough information exchange from the other management levels to his / her team and vice versa and escalation of GMP compliance issues.
Ensures and manages the interfaces to the Manufacturing teams, QC, Support Functions, Project- and Site Engineering.
Qualification and Skills required
Master or PhD (preferred) in Natural Sciences.
More than 7 years of experience in the area of biopharmaceutical manufacturing, preferably in a quality & compliance function.
Strong background in cGMPs and Quality Management Systems is an asset.
Strong leadership skills; very good communication skills and interaction with all kind of interfaces within the organization and with regulatory agencies (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 large investment projects, from planning to successful health authority inspections.
Languages : English and German