Director GCP Quality Assurance (gn)

Responsible for working on our Phase III Myelofibrosis program, Pelabresib; managing inspection preparationreadiness and hosting inspections; conducting and reporting audits (either directly or using consultants / CRO);...

Director GCP Quality Assurance (gn)

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.

Position Summary

• Responsible for working on our Phase III Myelofibrosis program, Pelabresib
• Managing inspection preparationreadiness and hosting inspections
• Conducting and reporting audits (either directly or using consultants / CRO) and further development of the QMS (Quality Management System), GCP quality advising and risk identification and CAPA management
• Experience with Good Pharmacovigilance Practice (GVP) is desirable

Your Responsibilities

• Provide support and guidance during and following internal and external audits, and for regulatory inspections
• Lead and plan / strategies inspection readiness activities for a program and project; support inspection preparation on site at sponsor / vendor / site level. Perform / coordinate mock inspection activities
• Provide leadership and direction for ongoing projects, cross-functional teams, and at management review meetings on GCP related activities / issues and act as GCP expert for Constellation / MorphoSys
• Contribute and implement GCP / GVP / GLP compliance risk-based audit strategy and master audit plan. Being part of management, planning, conduct, approval, and close-out of audits (e.g. for a specific clinical development drug program(s) or subtype of audit)
• Provide subject matter expertise and participate in the development and review of Governing Documents (Policies, SOPs etc.)
• Liaise with respective internal functions to assess job role training requirements and participate in the development and execution of GCP / GVP governing documents and related training
• Maintain an in-depth understanding of business principles, industry trends, and the regulatory environment related to GXP activities
• Drive process improvement, provide expertise and consultative guidance on GXP business initiatives involving systems, processes, procedures, regulations, and tools intended for use in clinical trial conduct and/or regulated drug development activities
• Represent QA function as assigned in the CTT:
  • Participate in the Protocol Deviations (PD) review meetings to identify the trend analysis and recommendations
  • Participate in Risk Review meetings to identify the trend analysis and recommendations
  • Participate in the vendor management (e.g. qualification, requalification and implementing quality agreements)
• Contribute to the PRC meeting for protocol review
• Liaise with respective internal functions to assess job role training requirements and participate in the development and execution of GCP / GVP governing documents and related training, conduct of internal trainings related to GCP as required
• Lead / mentor membersof GCP / GVP QA

Your Skillset

• Ideally experience of ten or more years within a pharmaceutical drug development GCP- / GVP-related discipline (clinical site and CRO auditing, inspection hosting and management, CAPA and quality management, training, and records management, governing document development and implementation)
• Bachelor’s degree, Masters / Ph.D. optional, in a scientific, health sciences, or quality-related field
• Knowledge of ICH GCP / GVP / GLP, FDA, EMA, other related ICH, FDA and general compliance and audit concepts
• Experience at CRO and Sponsor environments would be a great asset
• Excellent communication skills, both verbal and written
• Good project management and leadership skills
• Able to work independently as well as in a cross-functional, multi-cultural team
• Pro-active, solution-oriented mindset and sound judgment for evaluation of risks, guidance and escalations

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

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