Director Quality Assurance / Pharma and Biotech / Perm / GMP / FDA / CMC

Bedrijfsnaam: -
Plaatsingsdatum: 05/03/2019
Standplaats: -


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 and Biotechnology organisation, based in Zuid-Holland Netherlands.The CompanyOur client combines ‘single point of contact’ project management. From pre-clinical through commercialization, they provide high quality and flexible CDMO services to biopharmaceutical partners. This way our client enable their partners to harvest on their research activities and to enter and supply their markets with the most efficient use of resources.

Our client is a good known company with international aspects!

Role DescriptionOur client is searching for a Quality Assurance Director that will lead the quality operations to ensure compliance with EU and FDA directives.

'Big responsibilities requires great skills, knowledge and experience'. Are you ready?

As a Quality Assurance Director you will be responsible for the release of clinical trial materials or commercial batches. Also will you represent and communicate the quality policies and performance to authority bodies, customers and business partners. This way you ensure corresponding alignment in the company.

ResponsibilitiesYou will be responsible for a few important aspects.You will be responsible for the...

-...performance of the quality operations;
-...implementation of quality policies;
-...relationship and communication with Dutch inspectorate IGJ/Farmatec;
-...periodic reporting of the quality performance using key performance parameters;
-...external auditing;
-...service complaints or product quality complaints.
-...audit readiness and manage GMP inspections performed by Dutch inspectorate or FDA authorities;
-...good relationship and communication with customers;

RequirementsThe job can be the next step in your career. But every job has his requirements.

For this job you need to have an academic degree in life sciences, this can be an degree in pharmacy, immunology or virology. You also need to have experience with biotechnological production on clinical and industrial scale. Also do you need to have broad knowledge and experience with EU/FDA GMP guidelines and inspections.

It is not an easy job, but definitely worth!

You need to have 6-10 years of experience with biotechnology and CMC manufacturing. More is always better!

They are not searching for a boss, but for a leader with natural authority. Someone who is able to apply situational leadership. They are searching for a director with good communication skills on all levels including with officials and Sr. management. A director who is decisive, analytical and accurate. Someone who is able to be creative and who has a good knowledge of English, a good knowledge of Dutch is a plus!

Other informationOur client offers you a highly dynamic job in an interesting environment with great benefits including a competitive salary and contribution to pension and health insurance.

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




Plaatsingsdatum :
Referentienummer :
Standplaats :
Adres :
Postcode :
9723 HK
Opleidingsniveau :
Uren :
Nader te bepalen
Dienstverband :
Werkervaring :
5 - 10 jaar
Contactgegevens :