(Senior) Manager Quality Management (m/f/x)
Location
Gräfelfing | Germany
Job description
Your mission
The Senior Manager of Quality Management will be instrumental in maintaining and enhancing our quality management systems. You will collaborate with cross-functional teams to ensure compliance with GxP and other regulatory standards, contributing to our mission of delivering safe and effective products. Key Responsibilities:
- Quality System Oversight: Implement and manage quality/compliance systems and processes in line with ISO 9001, 21 CFR Part 11, ICH GCP, and other relevant standards.
- Regulatory Expertise: Maintain strong knowledge of EU/US pharmaceutical regulations, ensuring inspection readiness and successful management of regulatory inspections.
- Audit Management: Lead audit planning, conduct, reporting, and follow-up on CAPA for both internal and external audits.
- Collaboration: Support the Head of QM in inspection readiness strategies, and coordinate inspections and partner audits. Work closely with Clinical, Regulatory Affairs, CMC, and Preclinical teams.
- Quality Improvement: Support optimization of Immunic’s Quality Management System (QMS) for enhanced quality and efficiency.
- Team Development: Assist in the professional development of junior Quality Management colleagues.
Your profile
- A scientific background in pharmacy, biology, chemistry, or a related discipline.
- Proven experience in the pharmaceutical industry with a strong focus on Quality Management.
- Expertise in GxP and detailed knowledge of quality standards relevant to the pharmaceutical industry.
- Demonstrated experience in leading regulatory inspections and managing quality systems for biotech or pharmaceutical companies.
- Excellent communication skills and a very good cultural fit with Immunic's values and team.
- Fluent in German and English.
Why us?
- A permanent full-time position with attractive pay in an international, highly motivated and collegial team.
- Full office or hybrid is being considered.
- A dynamic, flexible, open and multi-cultural working environment.
- Participation in our company’s success through our stock option program.
- An innovative, fast growing company.
About us
Immunic Therapeutics is a dynamic biotechnology company with a pipeline of selective, orally available immunology therapies for the treatment of chronic inflammatory and autoimmune diseases. Currently, three small molecule product candidates are in various stages of clinical development. For more information, please visit: .
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