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Title:
Quality Manager
Company:
Ipsen Manufacturing Ireland Ltd
Job Description:
Are you looking for an opportunity to contribute to Drug Substance (API) development actively, ensure the Operational Quality Assurance of both internal and subcontracted activities, and develop a Quality Management System dedicated to GMP activities supporting drug substance development in an international setting?
If so, we have an exciting new opportunity for a Quality Manager to join our Global Pharmaceutical Development and Non-Clinical Quality organisation. This is a permanent position located at our Dublin site and reports into the VP, Pharmaceutical Development and Non-Clinical Quality.
The successful applicant will have in-depth knowledge of Drug Substance and Quality systems and their maintenance/implementation in API sites as well as operational Quality related to drug substance. Thorough understanding of drug substance pharmaceutical manufacturing (cGMP) and laboratory work. Previous exposure to pharmaceutical development is mandatory. They will embrace cross -team collaboration and be comfortable with a significant degree of autonomy.
Ipsen is a fast-growing biopharmaceutical group specialising in the development of innovative medicines in oncology, neuroscience and rare diseases. Our goal is to improve the quality of life of patients through the search for new solutions to targeted disabling diseases. We can offer you a wealth of fulfilling challenges & growth opportunities, and the chance to learn new technologies for small molecules and biologics thanks to a highly diversified product portfolio, and to contribute within a fast-moving organisation, an organisation that is genuinely game-changing!
If successful, you will be joining a welcoming, passionate, highly engaged and competent Quality team dedicated to Development activities, considered as a valuable partner by Development teams.
As Quality Manager, you will actively contribute to the strategy of becoming a Center of Excellence in the development of biologics, small molecules and strategical partner in the life cycle management of the established products. You will work transversally with the API Development in global locations, the global Pharmaceutical Development Quality and Dublin technical operations teams to ensure the identification and effective realisation of Quality activities required for the development of Drug Substances managed externally or internally. You will ensure the local deployment and sustainability of the global pharmaceutical Development Quality Management System.
Your role will also include:
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Ensure quality checking or approval of documents needed to manufacture and release batches such as the master batch records, related documents (instructions, forms, development protocol/report, etc.) clinical batches
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Manage quality events (such as deviations, out of specification results, change controls) ensuring the appropriate investigation and root cause analysis. Review and approve associated CAPA plan. Ensure an effective implementation of corrective and preventive actions in timely manner
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As Drug Substance Quality representative in development projects CMC cross functional workstream, ensure Quality support in projects with a high level of autonomy and expertise
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Team reinforcement through effective people management if appropriate
Knowledge and Experience
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Bachelor’s degree or equivalent in a scientific or technical discipline of relevance
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Direct experience in the regulated pharmaceutical industry, specifically including Quality Assurance, Quality Control, and Manufacturing Operations for Drug substance and/or Drug product
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Demonstrated experience working with third party manufacturing contractors
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People management experience
If you feel that this could be the right next step for you and can point to appropriate experience in the pharmaceutical industry, we would be delighted to engage with your application.
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IPSEN is committed to equality of opportunity for all staff and applications, individuals are encouraged to apply regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.
