Jobbeschreibung
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: www.imux.com .Join Immunic, a leader in pharmaceutical innovation, as our Senior Manager of Quality Management. This pivotal role focuses on maintaining and enhancing our quality management systems, ensuring the delivery of safe and effective products in compliance with GxP and other regulatory standards. You'll collaborate with cross-functional teams to uphold the highest standards of quality and regulatory compliance.
- Quality System Oversight: Implement, manage, and enhance quality and compliance systems aligning with 21 CFR Part 11, ICH GCP, and other applicable standards.
- Regulatory Expertise: Maintain expert knowledge of EU/US pharmaceutical regulations, lead regulatory inspections, and ensure continuous inspection readiness.
- Audit Management: Oversee the planning, execution, and reporting of internal and external audits, and manage corrective and preventive actions (CAPA).
- Collaborative Leadership: Partner with the Head of Quality Management in developing inspection readiness strategies. Coordinate with Clinical, Regulatory Affairs, CMC, and Preclinical teams to ensure unified compliance and quality standards.
- Quality Improvement: Actively contribute to the optimization of Immunic's Quality Management System (QMS) for increased quality and operational efficiency.
- Team Development: Mentor and support the professional growth of junior Quality Management colleagues. Train and provide GCP advice to the crossfunctional stakeholders.
- A Bachelor's or Master's degree in Pharmacy, Biology, Chemistry, or a related scientific discipline.
- A minimum of 5 years of professional experience in Quality Management and Quality Assurance within the biotech or pharmaceutical industry.
- Deep understanding of GxP regulations and proficiency in quality standards critical to the pharmaceutical sector.
- Proven track record in leading regulatory inspections and excellence in managing complex quality systems.
- Outstanding communication skills and a strong alignment with Immunic's values and team culture.
- Proactive approach in all Quality matters
- Fluency in English is mandatory. German is a plus.
Join us and be part of a company where your work directly contributes to our mission of improving patient care through groundbreaking research. Immunic AG offers a stimulating work environment where innovation and collaboration are valued. We provide competitive compensation, comprehensive benefits, and opportunities for professional growth.
View More