Senior QA Manager (GCP) Business Process
Location: NetherlandsSIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science 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!
THE COMPANY
Our client is a professional Biotechnology and Pharmaceutical organization, based in Zuid-Holland Netherlands.
Driven by the commitment to patients, the client brings innovative products, services and solutions to people throughout the world.
ROLE DESCRIPTION
The QA Manager is accountable for a larger section of the procedural framework and is responsible for ensuring that GxP and similar requirements are adequately described. He/she will contribute to the development of a quality system that enables the Global Clinical Development Organization to conduct clinical trials in an efficient and compliant way, resulting in clinical programs that allow for seamless registration of the compounds.
RESPONSIBILITIES
Accountabilities
- He/she will Lead or participate in improvement projects to describe the new desired state of processes for compliance. Gather and analyze metrics, CAPA and other performance data of the existing process, describe requirements and develop with the partners to be processes.
- He/she is responsible for the implementation, improvement and design projects related to the procedural framework for GxP and business processes, either as leader or key team member and has to design and implement Role Risk based training plans. Moreover, he will contribute to the development of a quality system.
- He/she will contribute to the development of a quality system that enables the Global Clinical Development Organization (GCDO) to conduct clinical trials in an efficient and compliant way, resulting in clinical programs that allow for seamless registration of the compounds.
REQUIREMENTS
- Quality manager with a master's degree or BS/BA
- 8 years' experience in a medium to large scale matrix organization which includes applicable compliance related field and/or equivalent time and experience in a related R&D area is required
- Requires knowledge of the drug development process, good knowledge of worldwide GxP compliance regulations, GCP, company quality assurance procedures and policies
- Personal leadership skills
- Excellent knowledge of English is required
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Laura Hoekstra.
