QA Project Manager - Drug Product 80 - 100% (m/f/d)

Today, Lonza is a global leader in life sciences operating across five 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.

• An agile career and dynamic working culture

• An inclusive and ethical workplace

• Compensation programs that recognize high performance

• A variety of benefits dependent on role and location

• Establish Quality Agreements (QAA) in close collaboration with Drug Product Services DPS in Basel / Stein and LONZA Drug Substance (DS) sites (e.g. Slough / Visp).

• Act as QA representative in Project teams and represent QA in customer meetings during Technical Transfer.

• Act as QA contact for specific projects and realize the interface for DRs and CRs with the customer (routine follow-up’s).

• Act as point of contact for Drug Product QA related questions, topics and complaints from customers related to the manufacturing operations.

• Organize customer audits together with the Visp Compliance team and DPS Basel functions.

• Support and approve project / product specific risk assessments or regulatory specific risk or gap assessments.

• Review and release product specific documentation such as process descriptions and workflows, recipes, manufacturing protocols, transfer documents, test plans, parameter lists, etc.

• Work closely with QC-Project Leader (QC-PL) and MSAT for New-Product-Introductions (NPI).

• Support general organization of inspections (front / back office).

• Represent Drug Product QA topics during regulatory inspections.

• Support continuous improvement programs to establish an effective Quality Management System for Visp DPS.

• Represent Quality Assurance in cross-functional teams, establish and maintain interfaces with the Manufacturing teams, QC, Support Functions, Project- and Site Engineering project / technology transfer to effectively execute tasks related to Drug Product processes.

• Assess, review and approve quality records and release files/dossiers e.g. deviations, change control, CAPAs, investigations, effectiveness checks, extensions, complaints, APR/PQRs, in line with current local SOPs.

What we’re looking for:

• University degree or equivalent in Chemistry / Biology / Biotechnology or a related field

• Long-term experience working in the GMP environment of the pharmaceutical industry

• Experience working in a QA department would be an advantage

• Business fluent English is required, German language skills are 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.