New Products – QA Manager (m/f/d) | GMP | Oncology

An international pharmaceutical company based in Berlin is currently seeking a QA Manager (m/f/d) to support its continued growth. This role focuses on highly specialized oncology new products, manufactured by only a limited number of companies in Germany and characterized by complex scientific and regulatory challenges.

Your Responsibilities

• Maintain, review and continuously improve the Quality Assurance system in compliance with GMP
• Create, review, approve and maintain GMP-related documentation
• Support Production and Quality Control on quality-related topics
• Manage deviations, OOS/OOT cases, change controls and CAPAs
• Prepare for, support and follow up on regulatory inspections
• Conduct self-inspections and perform audits of CMOs, suppliers and contract laboratories
• Train employees on QA and GMP-related topics

Your Profile

• University degree in Pharmacy, Chemistry, Biology or a comparable scientific discipline
• 2–5 years of experience in Quality Assurance within a GMP-regulated pharmaceutical environment
• Solid knowledge of GMP regulations
• Good command of German and English, written and spoken (German language niveau must be at least at C1 level)

What the Company Offers

• Exposure to scientifically challenging oncology niche products
• Flexible working hours and home office options after probation
• Strong and sustainable company growth: Revenue increased from EUR 246 million (2023) to EUR 296 million (2024), with a forecast of EUR 320 million for 2025
• Long-term career development opportunities in a stable, growing environment
• Relocation cost support

If this opportunity sounds interesting to you, I would be happy to connect confidentially

Due to high number of application, only suitable candidates will be given feedback.