Senior QA Expert, Manufacturing 80-100%

Job-Room; Stein; Hybrid; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Lonza in Stein, AG, Switzerland is seeking a QA professional to drive operational readiness from a Quality perspective on a growth project. You will oversee shopfloor manufacturing activities, ensure GMP compliance, and review SOPs to support start-up and sustainable operations; a hands-on role requiring aseptic gowning.

You will lead deviations, CAPAs, investigations, and quality records, act as Quality representative in audits and inspections, and collaborate with Manufacturing teams to ensure

Qualifikationen

• Experience in GMP-regulated pharma industry.
• Sterile/drug product manufacturing expertise.
• Fluent German and English communication.
• Willingness to work on the shopfloor and aseptic gowning.
• Advanced degree in life sciences or related field; strong stakeholder management.

Aufgaben

• Provide QA oversight for shopfloor manufacturing activities within a GMP growth project and ensure compliance and readiness.
• Review and approve SOPs, work instructions and GMP documentation to support start-up and sustainable operations.
• Coordinate aseptic process readiness with Manufacturing, including training support and execution readiness for APS and future media fill activities.
• Lead and coordinate quality events by reviewing deviations, CAPAs, investigations and related quality records; ensure timely resolution.
• Serve as Quality representative during project discussions, audits and inspections, communicating the oversight strategy and supporting inspection readiness.

Kenntnisse

GMP experience

Sterile manufacturing

Quality oversight

CAPA investigations

Regulatory audits

German & English

Ausbildung

Life sciences degree (BSc/MSc/PhD)

Jobbeschreibung

The actual location of this job is in Stein, AG, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed. Be part of an exciting project-phase team driving operational readiness from a Quality perspective, ensuring robust documentation, SOP compliance, aseptic process preparedness, and effective deviation and CAPA oversight. This role offers the chance to influence how future manufacturing operations are established, making it an ideal step for professionals looking to transition from production into Quality Assurance. This role is primarily based on site. Working together in person supports close, real-time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards. We offer flexibility to work remotely for no more than 20% of your time. Requests are considered on a case-by-case basis, in line with business needs.

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.

The full list of our global benefits can be found here: https://www.lonza.com/careers/benefits

Our local benefits: 3cf206339e0e4e41a77e8c806138c2b5

What you will do:

• Provide QA oversight for shopfloor manufacturing activities within an exciting growth project, ensuring compliance with GMP requirements and operational readiness.
• Review and approve SOPs, work instructions, and other GMP documentation to support successful start-up and sustainable manufacturing operations.
• Partner with Manufacturing teams to drive aseptic process readiness, including preparation, training support, and execution readiness for APS and future media fill activities.
• Lead and coordinate quality events by reviewing and approving deviations, CAPAs, investigations, and related quality records, ensuring timely and effective resolution.
• Act as the Quality representative during project discussions, audits, and inspections, clearly communicating the quality oversight strategy and supporting inspection readiness.

What we are looking for:

• Proven experience in the pharmaceutical industry within a GMP-regulated environment, with expertise in sterile and/or drug product manufacturing is a must
• Experience in quality oversight, management of deviations, CAPAs, and investigations.
• Fluent German and fluent English communication skills are essential, enabling effective collaboration with shopfloor operators, cross-functional teams, customers, and regulatory authorities.
• Willingness to spend significant time on the manufacturing shopfloor, including working in full aseptic gowning, and a hands-on approach to supporting operations and driving quality excellence is a must
• Bachelor's, Master's, or PhD degree in Life Sciences, Pharmacy, Chemistry, Biology, Biotechnology, or a related field, combined with a pragmatic, solution-oriented mindset, strong stakeholder management skills, and the agility to thrive in a dynamic greenfield project environment.
• Experience supporting regulatory and customer audits and inspections 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.