Biologist, Life Scientist - GCP Audit, Clinical Studies (m/f/d)
- Recruiter
- Daiichi Sankyo Europe GmbH
- Location
- Bayern
- Salary
- Competitive salary
- Posted
- 19 Feb 2021
- Closes
- 03 Mar 2021
- Ref
- 146420_b3ff5ea
- Job role
- Audit
- Sector
- Accounting - Public practice
Passion for Innovation. Compassion for Patients.™
Daiichi Sankyo and its 15.000 employees in more than 20 countries are dedicated to the creation and supply of innovative pharmaceutical products. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology. Our European headquarters are in Munich, Germany and we have affiliates in 13 European countries including Denmark, where Copenhagen acts as the Nordic headquarter.
For our headquarter in Munich we are seeking highly qualified candidates to fill the position:
Senior Manager GCP Audit (m/f/x) The Senior Manager GCP Audit will provide assurance to the Global QA GxP Audits Team that the 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 the assurance to the Global Daiichi Sankyo Quality Management that all aspects of GCP regulatory inspections, vendor and clinical site by Competent Authorities / Health Authorities will be handled and managed adequately and appropriately.
Roles and responsibilities:
Manage assigned aspects of a fully functional QA GCP audit program as assigned by the Head Global GxP audits for Daiichi Sankyo Global phase I through IV studies of clinical development and supporting discovery phase QA activities 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 Daiichi Sankyo conducts clinical trials
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.
Collaborate and represent the Global QA group in conducting 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
Bachelors 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 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 globally
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.
Daiichi Sankyo and its 15.000 employees in more than 20 countries are dedicated to the creation and supply of innovative pharmaceutical products. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology. Our European headquarters are in Munich, Germany and we have affiliates in 13 European countries including Denmark, where Copenhagen acts as the Nordic headquarter.
For our headquarter in Munich we are seeking highly qualified candidates to fill the position:
Senior Manager GCP Audit (m/f/x) The Senior Manager GCP Audit will provide assurance to the Global QA GxP Audits Team that the 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 the assurance to the Global Daiichi Sankyo Quality Management that all aspects of GCP regulatory inspections, vendor and clinical site by Competent Authorities / Health Authorities will be handled and managed adequately and appropriately.
Roles and responsibilities:
Manage assigned aspects of a fully functional QA GCP audit program as assigned by the Head Global GxP audits for Daiichi Sankyo Global phase I through IV studies of clinical development and supporting discovery phase QA activities 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 Daiichi Sankyo conducts clinical trials
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.
Collaborate and represent the Global QA group in conducting 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
Bachelors 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 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 globally
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.