Director Global Clinical Quality

SIRE Life Sciences® - More jobs by this advertiser
SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical organisation, based in Nordrhein-Westfalen Germany.

The Company

Our client is a company in the field of biopharmaceutics with a global outlook

Role Description

Our client is looking for a Director Global Clinical QA

Responsibilities

- Outlining a program for clinical quality risk management that decreases risks connected with the safety of patients, integrity of data, and compliance to regulations and putting it into action
- Supporting activities linked to the international development of new drugs and / or indications and those regulated by Good Clinical Practice by providing investigative support

- Identification of eventual critical quality risk factors as well as their probable impact
- Correction of possibly complex situations through the clinical governance model while working and collaborating with business partners and stakeholders
- Engaging in the planning process, coordination and execution of Clinical Quality Assurance activities determined in risk mitigation programs for the validation of systems and processes in order to provide for subject safety and protection as well as data reliability and validity
- Supervision of risk mitigation activities as part of the clinical program as well as the coordination and inspection of the output of trends from the risk mitigation program
- Taking the lead or helping as well as hosting activities and coordinating prompt responses in the course of regulatory inspections and investigations handled by regulatory authorities
- Arranging CQA GCP support in course of the development and implementation of E-systems as well as new technologies and clinical trials

Requirements

- Bachelor's degree
- Experience in auditing (e.g. investigator site, vendor, system, database, device, IT)
- Established knowledge of global regulations, quality principles, techniques and trends in the area of biopharmaceutics
- Good understanding and knowledge of Good Clinical Practice, relevant regulations, and best practices in the area of development of pharmaceutical products, devices, combination products as well as mobile medical applications
- C1 or higher level in English, a second language is a plus
- High quality standards, honesty and reliability as personal assets

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Kimberly Schaperklaus.


SIRE Life Sciences®


Amsterdam, (Netherlands)

Phone: +31 (0)20 658 9800
Web: http://sire-search.com

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Company Profile

7 March 2019
Location: Germany Germany
Salary: Competitive Salary
Work type:
Full time
Sector:
Life Sciences
Profession:
Testing and Quality Assurance

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