Regulatory Affairs Manager Bioprocess (m/w/d)

• Author, own and maintain internal guidance and training documentation

Collaborate with various functions within the global company, internal and external suppliers and with customers with the objective to share expertise and provide guidance

Review documents to ensure alignment regarding GMP customer expectations and suitability in the framework of GMP guidelines

Provide target group specific trainings and participate in global broadcast presentations

Close collaboration with the Quality team to align on concept and proper application of existing quality systems and support their development

Providing active support to colleagues in implementing requirements and translate them into solutions

• Degree (Bachelor, Master, PhD) in the field of natural science, biotechnology or comparable

Solid quality background, specifically with core GxP systems like Change Control, Deviation Management, CAPA

Professional experience in quality or regulatory in manufacturing pharma industry, CMO/CDO/CDMO companies or in industry developing, manufacturing, and marketing of equipment for use in pharmaceutical manufacturing

Professional experience with specific quality tools used in pharmaceutical industry like: Computer software validation (CSV) based on the principles of e.g. 21CFR11, Equipment qualification (IQ/OQ) Eurdalex Vol 4 Annex 15, Process Validation, Extractable / Leachable data generation and evaluation, Critical impurities and contact material compliance (e.g. TSE)

Excellent communication skills in German and English in spoken and writing

Accurate and detail-oriented mindset

Highly skilled in standard Microsoft Office applications

Passionate and motivating attitude

Your work is meaningful. Together we contribute to improve human living conditions.

• We offer you creative freedom with a strong, international premium brand in the life science industry.
• Thirty vacation days per year and company-regulated special leave days are a given with us.
• With our flexible flextime framework and a working time account, you can plan your working hours individually and independently create a balanced work-life balance.
• We also offer you the opportunity to work remotely across Germany for part of your working time, tailored to suit your life situation.
• We provide you with a variety of social benefits, such as additional employer-funded retirement plans, a job bike, public transport subsidies, corporate benefits, etc.
• To deepen your knowledge and continuously develop professionally and personally, we offer you a wide range of freely selectable training sessions, participation in conferences, and access to learning platforms.
• With us, you will find a diverse, open-minded, and appreciative work environment with the latest technologies, methods, and tools in a set