Senior Quality Assurance Expert Compliance, Drug Product Services

Lonza; Stein; Hybrid; Vertraulich; Vollzeit

Benefits dieser Stelle

Agile career

Inclusive workplace

Compensation programs

Zusammenfassung

Lonza, based in Stein, AG, Switzerland, is seeking a Supplier Qualification Specialist to drive GMP-relevant supplier qualification activities for materials, services and equipment across Basel and Stein, coordinating with Supply Chain, Quality, Engineering and Manufacturing.

The role serves as the primary Quality contact for supplier qualification, reviews complex documentation, manages CAPAs and deviations, and supports customer audits and regulatory inspections with global teams.

Qualifikationen

• Academic degree or vocational training in chemistry, biology, pharmaceutical sciences or related field.
• At least three years in a GMP-regulated pharmaceutical environment with quality and compliance knowledge.
• Experience in QA or Supply Chain with supplier management and cross-functional collaboration.
• Experience in QA, supplier qualification, quality control, and sterile manufacturing environments is desirable.
• Exposure to customer and regulatory audits (Swissmedic, FDA) is a strong advantage.
• Fluency in English; business German is a plus.

Aufgaben

• Manage the qualification and lifecycle management of GMP-relevant suppliers for materials, services, and equipment, ensuring compliance with global quality standards, procedures, and regulatory requirements.
• Act as the primary Quality contact for supplier qualification at Drug Product Services in Basel and Stein, partnering closely with Supply Chain, Manufacturing, QC, Engineering, and other key stakeholders.
• Review, approve, and maintain supplier-related documentation, managing complex cases involving supplier qualifications, quality agreements, and compliance requirements.
• Drive the effective resolution of supplier-related CAPAs, deviations, quality escalations, and change requests while collaborating with global teams, including colleagues in Switzerland and India.
• Represent Supplier Quality as a Subject Matter Expert during customer audits and authority inspections, confidently presenting supplier management processes and elaborating on specific cases.

Kenntnisse

Quality Assurance

Supplier qualification

Cross-functional collab

GMP knowledge

Regulatory knowledge

Ausbildung

Chemistry/Pharma degree

Jobbeschreibung

Switzerland, Stein

The actual location of this job is in Stein, AG, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.

In this role, you d drive supplier qualification activities for GMP-relevant materials, services, and equipment across Basel and Stein, collaborating with diverse stakeholders from Supply Chain, Quality, Engineering, and Manufacturing. In this highly visible role, you will act as a key interface between teams in Switzerland and India, reviewing complex supplier documentation and representing supplier quality topics towards customers and authorities. Check out Your Career in Drug Product Services at Lonza !

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

• Manage the qualification and lifecycle management of GMP-relevant suppliers for materials, services, and equipment, ensuring compliance with global quality standards, procedures, and regulatory requirements.
• Act as the primary Quality contact for supplier qualification at Drug Product Services in Basel and Stein, partnering closely with Supply Chain, Manufacturing, QC, Engineering, and other key stakeholders.
• Review, approve, and maintain supplier-related documentation, managing complex cases involving supplier qualifications, quality agreements, and compliance requirements.
• Drive the effective resolution of supplier-related CAPAs, deviations, quality escalations, and change requests while collaborating with global teams, including colleagues in Switzerland and India.
• Represent Supplier Quality as a Subject Matter Expert during customer audits and authority inspections, confidently presenting supplier management processes and elaborating on specific cases.

What We Are Looking For

• Academic degree or vocational training in chemistry, biology, pharmaceutical sciences or related field
• At least three years of experience in a GMP-regulated pharmaceutical environment, with a strong understanding of quality and compliance requirements.
• Proven experience in either Quality Assurance or Supply Chain, preferably including supplier management and cross-functional collaboration within complex manufacturing environments.
• Experience in Quality Assurance, supplier qualification, quality control, and sterile manufacturing environments is highly desirable.
• Former exposure to customer and regulatory audits (e.g., Swissmedic, FDA) is a strong advantage.
• Fluency in English, with the ability to communicate effectively across global teams and stakeholders. Business level German is a plus.

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.

Reference: R78722