Head of Quality Assurance

vor 1 Woche


Planegg, Deutschland CatalYm GmbH Vollzeit

**Head of Quality Assurance (M/F/d)**
Festanstellung, Vollzeit - Planegg-Martinsried

**Your mission**

**Your tasks and responsibilities**
- Lead the further implementation activities towards a comprehensive quality management system (QMS) covering all GxP areas, including the transition to an electronic QMS solution
- Drive and lead inspection activities according to global regulatory requirements (e.g. FDA, EMA, etc.)
- Develop risk-based approaches to quality management in clinical development
- Collaborate with C-level to align quality initiatives with business objectives
- Provide strategic direction for Quality Assurance in clinical trials and pharmacovigilance activities
- Oversee the planning and execution of internal and external audits across all GxP areas
- Manage relationships with regulatory agencies and represent the company in quality-related matters
- Drive the initiatives of quality technology solutions to enhance efficiency and compliance

**Your profile**
- Advanced degree in life sciences or related field with 15+ years of experience in pharmaceutical/biotech quality assurance, including significant experience in GCP and GVP
- Several years of experience in clinical studies according to ICH-GCP
- Experience in preparing for and managing regulatory inspections
- Proven track record in quality leadership roles within clinical development
- Comprehensive knowledge of global GxP regulations, with main expertise in GCP and GVP
- Strong leadership skills with the ability to influence at all levels of the organization
- Excellent analytical and problem-solving skills
- Fluent in English with excellent oral and written skills; good level of German.

**Why us?**
- Working in an innovative and dynamic environment and being part of a thriving biotech company
- Great working atmosphere within a highly motivated and multicultural team
- Creative working in X-functional teams
- Short communication channels
- Flexible working hours, office and home office based, enable time management on your own terms
- permanent contract

Auf diese Stelle bewerben

**About us**

CatalYm is a biotech company based in Martinsried near Munich, developing innovative immunotherapies to transform cancer patients’ lives by effectively engaging their own immune systems to combat this malignant disease. We are now advancing to Phase 2b studies to confirm visugromab, our lead antibody, that has demonstrated durable anti-tumor efficacy with long-lasting objective responses in relapsed and refractory metastatic solid tumor patients in combination with anti-PD-1 treatment. Our mission is to rapidly bring our next-generation immuno-oncology products to patients in need. Are you ready to board the fast-accelerating visugromab train in Martinsried? Then join us



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