About this role
Location: the actual location of this job is in Visp, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.
The Senior QA Manager (f/m/d) is a member of the QA Operations Unit and responsible for overseeing QA Documentation Team and QA Shop Floor team ensuring the QA oversight and shop floor presence over the Drug Product area in all matters of cGMP in compliance with national/international requirements and standards.
What you will get:
An agile career and a dynamic work culture.
An inclusive and ethical workplace.
Compensation programs that recognize high performance.
In addition to a competitive salary, you can expect numerous lifestyle, family, and leisure benefits. Our full list of tailored local benefits can be found below.
Benefits in Visp: https://bit.ly/3wjkoFi
What you will do:
Plan, lead and coordinate:
QA Oversight activities, including implementation of the QA Oversight program and execution of QA Oversight during APS and during routine Manufacturing and testing activities per QA Oversight plan.
QA review and approval of Aseptic Processing Simulations (APS) process, including implementation of APS strategy, set-up of APS annual plan, APS protocols and APS reports
Batch Record Review (paper documentation and Manufacturing Execution Systems (MES))
MES implementation (QA representative in the project)
Archiving of documents (e.g. paper copies or scans for true copy)
Lead Deviation Review Board (s) meetings
Provide GXP-related trainings to Module D Operations personnel
Author, review and approve GMP-relevant documents and SOPs.
Support continuous improvement programs to establish an effective Quality Management System for DPS Visp
Prepare batch release documentation package for the responsible person (FvP), including completion of release related items (DRs, CRs, INV, CAPAs etc) and recommendation on disposition status, to ensure timely release activities.
Support QA PL for Customer management in regards to QA Operations topics (change controls, deviations, technical complaints, out of specification results, quality agreements)
What we are looking for:
University degree or equivalent in Chemistry / Biology / Biotechnology or a related field
Experienced in People Leading and Strategic role
Experience in a QA department specifically Drug Product is valuable
Fluent English language skills are required, German language is an advantage
About Lonza
At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.
Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.
Ready to shape the future of life sciences? Apply now.
Other facts
About Lonza
Lonza is a pioneer and world leader in the CDMO industry, setting the pace with cutting-edge science, smart technology, and lean manufacturing. United by a common purpose, we turn our customers’ breakthrough innovations into viable therapies and manufacture the medicines of tomorrow.
Founded in Switzerland in 1897, our company is the first and original CDMO, and today we are more dynamic, agile and forward-focused than ever before. As one of the largest Western CDMOs, we bring together a global team of around 18,500 colleagues across five continents to deliver comprehensive, integrated solutions for our customers' complex needs.
For our customers and their patients, we bring quality, safety and reliability to bring life-enhancing and life-saving treatments to market at speed and at scale. For our colleagues, we strive to create a sense of belonging and inclusion where every person can thrive and bring their best.
What you'll do
- Oversee QA Documentation Team and QA Shop Floor team, ensuring compliance with cGMP standards. Plan and coordinate QA oversight activities, including batch record reviews and training.
Ready to join Lonza?
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