This position has responsibility for Quality Assurance, and support of Quality Control, for external Oncology and Small Molecule Contract Manufacturing Organisations (CMOs), Suppliers, and Contract Testing Laboratories (CTLs) located within the European region, inclusive of Drug Product, QC testing, packaging, and labelling activities.
The External Supply Quality Manager is responsible for the Quality oversight of a portfolio of Contract Manufactures and associated products. The position requires interaction with numerous functions within the Oncology & External Supply Small Molecule (OncESSM).
Responsible for the product quality performance at designated CMOs/ Suppliers, to ensure compliance and quality risks are identified, communicated and mitigated, and are an integral part of business decisions consistent with relevant standards/ cGMP and Global Quality Standards.
Responsible for the preparation, approval and maintenance of Quality Agreements with relevant CMOs/ Suppliers.
Responsible for product quality performance through product and supplier Quality Risk Management, deviation/investigation review, change management, APQR evaluation, Key Performance Indicators (KPI) and other Quality processes and tools as required.
Support and champion the implementation of compliance strategies, quality plans and Quality Assurance programmes for the management outsourced product manufacturing/ packaging operations to assure the quality.
Responsible for complying with the requirements of the Quality Incident Management process for relevant CMO.
Assist with audits and inspections of Oncology & External Supply Small Molecule.
Minimum of Bachelor’s Degree in Pharmacy, Chemistry, Biology or related discipline and profoundf QA/QC experience in the pharmaceutical industry and/or QA/QC laboratory environment.
Experience of cGMPs, ICH and other pertinent regulations.
Project Management expertise desired.
Familiar with Common Technical Documents (registration files).
Communication – ability to communicate ideas and data both verbally and written in a persuasive and appropriate manner.
Analytical Skills – ability to thoughtfully analyse a wide variety of information and data to make key decisions regarding potential risks associated with product quality or regulatory violations.
Teamwork – ability to establish professional relationships and rapport with internal and external peers and higher-level management.
Proactiveness – ability to anticipate potential problems and risks related to commercial product operations, investigate solutions, and implement preventive actions.
Regulatory understanding – broad based knowledge of domestic, and general knowledge of international regulations associated with manufacturing and packaging.
Fluent in written and spoken English.
Good communication skills engaging stakeholders: site, business, network, company, regulators, etc.
Enterprise thinking - finding innovative ways to serve patients build reputation and trust.
Elevate capabilities for now and the future.
A very renowned pharmaceutical company
Pleasant working atmosphere
Über Hays: With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
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