Senior Manager GCP Audit (m/f/x)

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Date: 24-Nov-2021

Location: Munich, Germany, 81379

Company: Daiichi Sankyo Europe

 

Passion for Innovation. Compassion for Patients.

 


Daiichi Sankyo and its 16,000 employees in more than 20 countries are dedicated to the creation and supply of innovative pharmaceutical products. In Europe, we focus on two areas: In the cardiovascular space, our strong portfolio of medicines reflects our long-standing commitment and shows that we care for every heartbeat; in oncology our goal is to become a global pharma innovator until 2025 by providing novel therapies to patients across the world. Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries. For more information: www.daiichi-sankyo.eu.

 

 

For our headquarter in Munich we are seeking highly qualified candidates to fill the position

 

Senior Manager GCP Audit (m/f/x)

 

Purpose of the function:


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

 

 

Personal skills and professional experience:

 

  • 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 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 

 

 

What we offer


Working at Daiichi Sankyo

At Daiichi Sankyo in Europe, we offer a workplace where your voice is heard. Everything we do, we do with a high level of commitment and a clear focus on patients’ needs. We know that our bold ambition to change patients’ lives for the better can only be achieved through the power of collaboration and the exploration of new approaches. Thus, we encourage our colleagues across Europe to be courageous, to bring their ideas to the table and to embrace opportunities to grow. When you join our European family, you will be a part of a dynamic company where everyone, no matter their role, rolls up their sleeves and gets things done.