Supplier Qualification Lead Auditor (GMP/GDP)

Job title: Supplier Qualification Lead Auditor (GMP/GDP)

About the Role We are seeking an experienced Supplier Qualification Lead Auditor (GMP/GDP) to manage the qualification of suppliers, service providers, and Contract Manufacturing Organizations (CMOs) within a GMP environment. Special expertise in IT supplier qualification is highly desirable.

What You'll Do

• Plan, perform, coordinate, and close external audits as a qualified Lead Auditor (GMP/GDP).
• Manage supplier documentation and qualification oversight, including maintaining supplier data in Veeva eQMS.
• Coordinate claims and communicate with suppliers and subject matter experts (SMEs).
• Process and assess supplier notifications regarding changes, deviations, and risk assessments.
• Support the annual audit plan, supplier evaluations, and maintain the Approved Supplier List (ASL).
• Drive continuous improvement in supplier qualification processes and compliance activities.

What We're Looking For

• A degree in life sciences, such as chemistry, biology, pharmacy, or an equivalent field.
• At least 3+ years of professional experience in a similar role, ideally within a GMP/GDP environment.
• Qualified Lead Auditor (GMP/GDP) with proven expertise and several years of experience in supplier qualification and auditing.
• Strong IT skills, including experience with electronic quality management systems (e.g., Veeva eQMS).
• Excellent communication skills and experience working with interdisciplinary teams.
• Fluent in English and German, both written and spoken.
• Willingness to travel approximately 30%.

Nice to Have

• Special expertise in IT supplier qualification is highly desirable.

Compensation & Benefits

• It’s our priority to support you: flexible hours, vacation account.
• Growth opportunities: Digital Learning, Performance & talent development, leadership development, Apprenticeships, LinkedIn Learning.
• Company culture: your voice at the table, culture on an equal footing, opportunities to shape & impact, support for your full potential.
• Health & lifestyle: Company bike.
• Mobility: Job ticket, Deutschlandticket.
• Life stage: Employer-funded pension, childcare.
• Note: By submitting your application, you acknowledge a background check will be conducted through HireRight.