Senior GMP Supplier Quality & Compliance Lead

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

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.