Senior Manager/ Associate Director (gn) Quality Assurance GCP

Munich, Germany

About Us

At MorphoSys, we are motivated by our mission: More life for people with cancer. As a global, commercial-stage biopharmaceutical company, we are driven by the urgency to discover, develop, and deliver groundbreaking medicines, aspiring to redefine how cancer is treated.

Our success is created by our people, and we bring together exceptional talent from around the world, offering our colleagues a collaborative, flexible, and diverse work environment. We are looking for individuals who share our values and are motivated to improve the lives of people impacted by cancer.

Our headquarters are in Planegg, Germany and our U.S. operations are anchored in Boston, Massachusetts. To learn more, visit us at MorphoSys.com, and follow us on LinkedIn and Twitter.

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
  • Lead, plan and conduct audits in GCP/GVP areas
  • Working with contract personnel or consultants to prepare, conduct and report outsourced audits           
  • 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 quality and compliance risk management
  • Support Vendor Selection activities as assigned
  • Management of external GCP/GVP QA related service providers
  • 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

Your Skillset

  • 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

Our Culture & Benefits

  • Flexible working models
  • Attractive working in cross-functional teams
  • Open and appreciative culture
  • Multicultural environment with the brightest and most innovative people
  • Working in an attractive, high-quality building with a top notch restaurant
  • Attractive benefits for wellbeing  (financial and non-financial), recognition and development
  • International Development opportunities