Das ist der Job
Responsibilities include conducting on-site audits, follow-up actions, and documentation.
Darum lohnt es sich
A Good Match
• 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%.
Your Benefits
It's our priority to support you:
• Your flexibility: flexible hours | vacation account
• Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
• Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
• Your health and lifestyle: Company bike
• Your mobility: Job ticket | Deutschlandticket
• Your life phases: Employer-funded pension | Childcare Mainz, Germany | full time | Job ID: 11519
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.
• 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.
