Senior Manager GCP Audit (m/f/x)

For our European headquarters in Munich we are seeking highly qualified candidates to fill the position:

Senior Manager GCP Audit (m/f/x)

The position:

The Senior Manager GCP Audit will provide assurance to the Global QA GxP Audit Team with regards to the fact that QA GCP audits and due diligence efforts are fully functional and compliant with ICH GCP, the applicable national and international laws and guidelines and global Daiichi Sankyo written procedures. This role is responsible for assuring to Global Daiichi Sankyo Quality Management that all aspects of GCP regulatory inspections at DSE Munich, vendor and clinical sites by Competent Authorities / Health Authorities are handled and managed adequately and appropriately.

Key responsibilities:

• Manage assigned aspects of a fully functional QA GCP audit program for DSE phase I through IV studies of clinical development, and supporting discovery phase QA activity where necessary. 
• Manage and execute the investigator site, service provider and internal systems and process audit program to assure an all acceptable state of compliance.
• Support all aspects of GCP regulatory inspections at investigator sites, CROs, vendors and sponsor facility during preparation, conduct, coordinating responses to inspections, and to ensure supporting documentation, tracking and verification of CAPA implementation.  
• Assure that all studies managed by DSE or are performed under DSE legal responsibility are in compliance with GCP requirements and can withstand scrutiny from regulators in all countries where we study and register our products.
• Manage metrics and the implementation tracking of corrective and preventive actions as follow-up to audits and inspections.
• Work with Daiichi Sankyo Japan, Daiichi Sankyo USA and other Daiichi Sankyo QA groups in developing and implementing QA GCP objectives and audit schedules with regards to development related audits of CROs, investigator sites, bioanalytical labs, etc.
• Work with and represent the Global QA group by e.g. leading joint audits and global SOP development.
• Liaise and consult with Early and Late Strategy, Development Teams, Pharmacovigilance, Operational and Technical Services and others to ensure local and global compliance with regulatory requirements, good clinical practice, internal standards, and to provide pro-active integration of quality and process improvement.

Professional experience and personal skills:

• Bachelor's degree required - life sciences degree preferred, e.g. Biology
• Demonstrated expertise and specific technical knowledge of the GCP (and PV) areas subject to audit, as evidenced by at least 7 years in the pharmaceutical industry and / or biotech industry
• Minimum 5 years of GCP auditing experience; additional PV auditing experience preferred
• Experience in preparing, hosting and following-up of regulatory authority inspections
• Profound knowledge of international GCP regulations and guidelines
• Excellent understanding of the drug development process and end to end quality process
• Excellent oral and written communication skills in English, German and ideally one other European Language
• User knowledge in MS Office 365, Trackwise, Veeva or similar software
• Team player who can work interculturally and is willing to travel 30% across Europe and sometimes globally

What we offer:

We offer an interesting, diversified and challenging position, good contractual conditions, flexible working models, all the social benefits of a modern company and a professional environment where you will have the opportunity for personal growth.