Your Tasks in Detail:

Supplier Quality & Material Qualification

• Responsibility for the qualification, evaluation, and monitoring of suppliers as well as the qualification of quality-relevant materials.
• Management of supplier complaints, including root cause analysis, CAPA measures, and effectiveness checks.
• Creation and maintenance of Quality Agreements as well as conducting quality-related supplier evaluations.
• Planning, execution, and follow-up of supplier audits.

Quality Systems & Compliance

Maintenance and further development of central GMP quality systems, taking regulatory requirements into account.
Ensuring compliance with GMP requirements, international guidelines, and legal regulations.
Evaluation of risk analyses and support in inspection readiness activities.
Planning, execution, and follow-up of internal audits.
Support during regulatory inspections and customer audits.
Follow-up of audit findings and implementation of corresponding CAPA measures.
Deputy team leadership for Quality Systems.

Regulatory Affairs CMC Interface

• Assessment of quality-relevant changes with regard to their regulatory impact on approved products.
• Support in providing quality-relevant documentation for regulatory submissions.

Continuous Improvement

• Taking on additional professional responsibility in the area of Quality Systems as well as active participation in the strategic further development of processes and quality systems.

Your Qualifications:

• Completed degree in Pharmacy, Chemistry, Biotechnology, Life Sciences, or comparable education.
• Several years of experience in Quality Assurance, Quality Systems, or Supplier Quality within a GMP-regulated pharmaceutical environment.
• Good knowledge of regulatory requirements as well as GMP, GDP, and ICH guidelines.
• Experience in supplier management, material qualifications, and handling change control processes.
• Knowledge of the interfaces between Quality Assurance and Regulatory Affairs CMC is an advantage.
• Auditor qualification or audit experience is desirable.
• Structured, independent, and solution-oriented working style with strong communication skills.
• Excellent German and English language skills.

What Our Client Offers:

• Interesting and challenging work with plenty of variety in your daily routine.
• Individual development opportunities and the chance to take on more responsibility.
• A motivated, interdisciplinary team and an open corporate culture.
• Subsidized lunch options and regular company events.
• An annual gross salary starting from €75,000, with various fringe benefits. Overpayment is possible depending on qualifications and professional experience.

If you are interested in this challenging position, we look forward to receiving your detailed application under reference number 112 014 via our ISG career portal or by email.