Global Quality Manager
Location: NetherlandsSIRE® 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 Utrecht Netherlands.
- Coordinate Global audits (internal/external) with several vendors and suppliers
- Asses timeliness of proposed CAPA's
- Read and extract developing regulatory and quality issues, integrated them into audits/assesments
- You are responsible for communication and managing of compliance related information (guidelines, global quality projects, compliance iniatives)
- Develop a new training program on areas of expertise
- Responsible for a new continuous improvement program
- 8 years of experience in Quality related environment (GxP)
- Experience in managing and improving QMS
- Strong knowledge of regulations for Quality Systems and Data Integrity
- Capable of analyzing data to provide support of developing strategies for resolving compliance issues
- Willing to travel (10%)
- You have at least a Green Belt Six Sigma
- Fluent in English (written/spoken)
Heb je interesse en wil je meer weten over deze functie, reageer dan door op solliciteer te klikken en contact op te nemen met Seppe Verhoeven
The Company
For a multinational in the pharmaceutical industry, specialised in rare disease, we are looking for a Global QM. The company is based in region Utrecht.Role Description
As Global Qualty Manager you are in charge for continuous improvement projects for the Global Quality Department. You responsibilities are performing risk assesments, compliance initiatives and QMS/GMP audits.Responsibilities
- Provide support to the 3 global manufacturing sites trough identification of compliance gaps and participation in remediations processes- Coordinate Global audits (internal/external) with several vendors and suppliers
- Asses timeliness of proposed CAPA's
- Read and extract developing regulatory and quality issues, integrated them into audits/assesments
- You are responsible for communication and managing of compliance related information (guidelines, global quality projects, compliance iniatives)
- Develop a new training program on areas of expertise
- Responsible for a new continuous improvement program
Requirements
- You posess a Master in Life Sciences- 8 years of experience in Quality related environment (GxP)
- Experience in managing and improving QMS
- Strong knowledge of regulations for Quality Systems and Data Integrity
- Capable of analyzing data to provide support of developing strategies for resolving compliance issues
- Willing to travel (10%)
- You have at least a Green Belt Six Sigma
- Fluent in English (written/spoken)
Heb je interesse en wil je meer weten over deze functie, reageer dan door op solliciteer te klikken en contact op te nemen met Seppe Verhoeven
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