Quality Manager

Ipsen Pharma

Dublin, Ireland

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.

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:

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
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
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
Team reinforcement through effective people management if appropriate

Knowledge and Experience

Bachelor’s degree or equivalent in a scientific or technical discipline of relevance
Direct experience in the regulated pharmaceutical industry, specifically including Quality Assurance, Quality Control, and Manufacturing Operations for Drug substance and/or Drug product
Demonstrated experience working with third party manufacturing contractors
People management experience

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