Senior Operational Excellence Manager (gn)

scheme imagescheme imagescheme image

MorphoSys’s mission is to make exceptional, innovative biopharmaceuticals to improve the lives of patients suffering from serious diseases. Innovative technologies and smart development strategies are central to our approach. Success is created by our people, who focus on excellence in all they do, collaborating closely across disciplines. We all are driven by a desire to make the medicines of tomorrow a reality. Guided by mutual respect and trust, each member of the MorphoSys team is given the opportunity to develop and flourish within this exciting and inspiring environment. Join us in Planegg near Munich!

Your Responsibilities:

  • Leads and/or contributes to cross-functional process improvement projects to drive efficiency and quality in Clinical Research activities (program and trial level) from solution development till training and implementation
  • Oversees the maintenance and updating of Standard Operating Procedures (SOPs) and business guidelines owned by Clinical Research functions
  • Interacts and educates Clinical Research teams and external Business Partners (i.e. Contract Research Organizations and Service Providers) on various aspects of quality and compliance
  • Develops and implements training programs to address training needs (competencies and skillsets) of the Clinical Research teams
  • Coordinates and guides Clinical Research teams in audit / inspection activities and in the development of corrective / preventive actions (CAPA), monitors the CAPA progress to ensure timely completion and close-out of CAPAs
  • Performs trending of audit / inspection findings and identifies areas which warrant an improvement of functional processes, and supports the development and implementation of the agreed solutions
  • Prepares the facilities and organizes all preparation activities for the sponsor Good Clinical Practice (GCP) / Pharmacovigilance (PV) inspection in collaboration with Quality Assurance

Requirements:

  • Thorough knowledge of Good Clinical Practice, regulatory guidelines (FDA / EMA / ICH), and clinical development process
  • Experienced in designing or re-designing functional processes to drive efficiency, quality and compliance improvement
  • Good understanding of business improvement methodologies, consulting techniques, innovation and learning solutions
  • Excellent communication, presentation and interpersonal skills
  • Quality focused and attention to details
  • Fluent English (oral and written)

We offer:

  • Creative working in X-functional teams
  • Open and appreciative corporate culture
  • Multicultural environment
  • Working in an attractive, high-quality equipped building with restaurant
  • Free sports and language courses

Thank you for your interest! We are looking forward to receiving your pertinent application documents. For your application please use exclusively our career portal. We offer not only excellent career prospects, but also support you from the very beginning – even helping you move if necessary.

MorphoSys AG, Semmelweisstraße 7, 82152 Planegg