QA Program Manager GCP
Worldwide responsibility quality and compliance of clinical programs
Weesp - The Netherlands
Offer
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A globally active, well-established and quality-based organization;
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International project management;
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Working with experts within a matrix organization.
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Continuous personal development;
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An excellent remunerations package.
Company
Abbott has a special mission: to improve people's lives. All over the world, millions of people rely on medicines and medical treatments from Abbott. Each of the company's 93,000 employees is dedicated to continuous improvement and innovation. In the Netherlands Abbott employs approximately 2,000 people in production, logistics, marketing and sales.
The imposing Abbott Healthcare Products B.V. premises in Weesp contain three plants of which two for chemical APIs (Abbott Healthcare Products B.V.) and the other for influenza vaccine (Abbot Biologicals B.V.) in bulk. Within the new Established Products Division (EPD) the QA EPD Development group is responsible for the quality and compliance of all EPD products. Within this group there is a vacancy for a QA Program Manager to operate in an international setting.
Position
As the QA Program Manager you will work in a newly established matrix team focused on GCP. You are responsible for the quality and compliance for the assigned program of which a lot will be executed in Russia, India or China. The manager acts as QA interface to the stakeholders in the clinical functions and for partnership and vendor management and represents EPD Clinical QA as a subject matter expert.
You will obtain and secure the ‘inspection readiness’ state for the product, projects and trials during the whole development phase. To obtain this level, you will assess external partners and organize QA oversight. You represent QA GCP in EPD development teams and advice and decide on QA and compliance related topics. With your thorough knowledge of regulations, you ensure that the experiments are performed in a compliant and practical way, whilst keeping in mind the business relations. You will drive towards quality improvement and risk management. You develop and maximize people (QA GCP Project Managers) and business potential in your team. Also you are responsible to give direction and guidance to the team You report to the Head EPD QA Development. In short: the perfect role for a driven and hands on QA expert with broad QA knowledge of GCP.
Profile
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Academic degree in pharmacy or related life science discipline;
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Minimum of 5 years QA experience in GCP (GMP experience is an advantage) in pharmaceutical area;
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Good knowledge of international regulations (WMO, ICH, GCP, GMP);
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Good communication and consultancy skills, decisive, hands-on mentality, strong interpersonal skills;
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Good command of the English language, both spoken and written.
Response
Interested? Send your curriculum vitae and letter of motivation to Mr. P. van Gelderen at Derks & Derks B.V., stating reference number WS/11-057-DD, e-mail: info@derksenderks.nl. For more details please contact Mr. Van Gelderen at +31 (0)33 - 4728087. A personal assessment may be required as part of the selection procedure.
Our client has deliberately selected Derks & Derks B.V. to handle the selection procedure. We therefore explicitly ask you to address your response to Derks & Derks.