Senior Manager/Associate Director Quality Assurance GCP
Senior Manager/Associate Director Quality Assurance GCP
MorphoSys
Planegg, Germany
Mission of Quality Assurance is to achieve excellence in auditing, quality management, quality risk assessment and enhance quality mindset for the benefit of our patients.
The job holder for this role is responsible for managing business relationships with defined stakeholder groups and senior leaders in Development / Clinical Functions for the strategic development and delivery of a GXP risk based robust quality assurance program and quality management activities for these stakeholders. Additionally, the job holder is responsible for delivery of proactive end‐to‐end GXP inspection support and management as well as managing and improving effective audit programs and perform audits.
Your Responsibilities:
- Leading and/or providing oversight to major regulatory inspections and provision of expert advice to Senior Managers on emerging regulatory issues
- Actively leading or contributing to the strategic direction for a risk-based assurance program
- Leading, planning and conducting audits in GCP/GVP areas
- Working with contract personnel or consultants to prepare, conduct and report outsourced audits within GCP / GVP
- Managing business relationships with stakeholder groups and senior leaders
- Leading or participating in the investigation of critical quality issues and ensure timely reporting of issues to relevant authorities
- Oversight of significant CAPAs for clinical activities
- Support and continuous improvement of the QM system related to GCP / GVP
- Accountable for providing expertise / consultations on GXP related issues to internal company Stakeholders / Departments as well as representing QA in interactions with Vendors
- Support Vendor Selection activities as assigned
- Primary contact partner for advice to GCP relevant departments for creation of SOPs
- Conduct of internal trainings related to GCP as required
- Contributing to functional budget management
Job Qualifications:
- University degree in biology, chemistry, medicine or related discipline or degree in area related to clinical development
- Ideally 8+ years professional experience in the area of clinical quality assurance/quality management including system and study audits at e.g. CROs, clinical trial sites
- Fluent in English
- Expert knowledge in the area of GCP and GVP preferably in national and international regulations
- Excellent Team Player and strong personality
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