Director Gcp Quality Assurance
vor 3 Wochen
**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.
**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) & 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/ strategise 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
- Contributes 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)
- 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
- To 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 functionsto assess job role training requirementsand 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 10+ 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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