Quality Manager Corporate Systems & Projects (Pharmaceuticals)

TL;DR

Quality Manager Corporate Systems & Projects (Pharmaceuticals): Continuous optimization of the Pharmaceutical Quality System (PQS) and regulatory compliance for finished dosage forms in EU and US markets with an accent on EMA, FDA, and EU-GMP requirements. Focus on managing quality agreements, supplier qualification, and overseeing GMP audits across international interdisciplinary teams.

Location: Hamburg, Germany

Company

hirify.global is a global family-owned business providing future-oriented pharmaceutical solutions through a vast international network.

What you will do

• Optimize the Global Pharmaceutical Quality System (PQS) and maintain regulatory compliance for wholesalers, importers, and releasers of medicinal products.
• Support finished dosage form programs throughout the entire lifecycle, from development to product launch.
• Provide quality oversight for clinical development activities, including GCP Quality Assurance.
• Advise project teams on regulatory developments and requirements from EMA, FDA, and EU-GMP.
• Manage Quality Agreements, supplier qualification, PQS documentation, and execute GMP audits.
• Provide expert technical troubleshooting on quality-related topics across the organization.

Requirements

• Master's degree in Pharmacy, Chemistry, Biology, or an equivalent scientific discipline.
• Several years of experience in pharmaceutical Quality Management, ideally within a generics environment.
• Solid knowledge of EU and US pharmaceutical regulations as well as German drug law.
• Experience in audits, clinical quality management, and pharmaceutical manufacturing processes.
• Proficiency in MS Office and quality IT systems such as eQMS and LIMS.
• English: Excellent communication skills required for effective work in international, cross-functional teams.

Culture & Benefits

• Opportunities for international career growth and professional development.
• Access to specialized seminars and further training.
• Benefits designed to ensure an optimal work-life balance.
• Collaborative environment within a unique, motivated family-owned business.