Senior QA Expert, Manufacturing 80-100%

Lonza; Stein; Hybrid; Vertraulich; Vollzeit

Benefits dieser Stelle

Lifestyle benefits

Competitive salary

Inclusive workplace

Career development

Zusammenfassung

Lonza is seeking a Quality Assurance specialist to provide robust QA oversight on shopfloor manufacturing activities, ensuring GMP compliance and readiness for sterile drug product operations.

You will review SOPs, support aseptic readiness, and lead deviation/ CAPA investigations while collaborating with Manufacturing teams and regulatory bodies.

Qualifikationen

• 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 for collaboration with shopfloor operators and regulators.
• Willingness to spend significant time on the manufacturing shopfloor, including full aseptic gowning.
• Bachelor's, Master's, or PhD in Life Sciences or related field, with a pragmatic mindset and strong stakeholder management.
• Experience supporting regulatory and customer audits and inspections is an advantage.

Aufgaben

• Provide QA oversight for shopfloor manufacturing activities within an exciting growth project, ensuring GMP compliance and operational readiness.
• Review and approve SOPs, work instructions, and GMP documentation to support start-up and sustained 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 deviations, CAPAs, investigations, and related quality records to ensure timely resolution.
• Act as the Quality representative during project discussions, audits, and inspections, communicating the quality oversight strategy clearly.

Kenntnisse

GMP expertise

Deviations management

CAPA investigations

Aseptic manufacturing

Quality oversight

Regulatory audits

German language

English language

Ausbildung

Bachelor's degree in Life Sciences or related field

Master's or PhD preferred

Tools

Regulatory documentation tools

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.

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. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.