Ipsen
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Quality Assurance Manager
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Ipsen Ipsen is looking for a Quality Assurance Manager to play a pivotal role in driving the development and optimization of biologics, neurotoxins, small molecules, and medical devices within the Global Pharmaceutical Development organization, which includes three European sites and one US site. Your contributions will support Ipsen's strategy to become a center of excellence in pharmaceutical development and will directly influence our ability to deliver high-quality, effective treatments to patients worldwide. Responsibilities
Manage from a Quality point of view on assigned projects, the production, documentation and review of formal stability batches, and batches of drug substance and investigational medicinal products intended for internal or subcontracted clinical trials to guarantee the conformity of the products with the appropriate reference documents Approve the documents necessary for the manufacture and release of batches such as Product Specification Files, Master Batch Records, Supply Chain flow diagram, associated documents (instructions, forms, development protocol/report, etc.), formal stability batches and clinical batches for drug substance and drug product Ensure the management of changes for assigned projects according to the procedures in place Manage from a Quality point of view the release of assigned products intended for clinical GMP trials and non-clinical GLP trials Handle Quality events (deviations, OOS, change control, complaints, CAPA), associated with development studies and products for non-clinical GLP and clinical trials i.e. conduct and/or evaluate investigations related to Quality events and ensure the implementation of corrective and preventive measures Anticipate and alert on any Quality issue that may impact on the Quality of products, the availability of products for clinical trials or the progress of projects Check that the transport conditions (temperature excursions) of products intended for clinical trials guarantee their proper conservation Ensure that assigned complaints are handled in accordance with procedures and within the required timeframe Inform in a timely manner the escalation of any deviation or major or critical complaints to the direct manager or the VP Quality Pharmaceutical Development Support the Quality decisions by providing the necessary information and recommendations. Contribute to the preparation and conduct of QSEBs Assist with mock recalls, contribute to batch recalls Ensure the implementation and compliance with procedures and instructions related to activities in his/her area of responsibility Manage Quality activities and relationships with CDMOs and service providers for assigned projects. Manage their upgrading on operational quality aspects (e.g., COAs, analytical validations/transfers, process validations, master & executed batch records, label proofs, specifications, executed batch record review and batch disposition of Drug Substance, Drug Product and Finished Products (oral solid dosage forms, parenteral, radio labeled materials)) Quality Support for Projects Development
As Quality representative in development projects CMC cross functional workstream, act as key partner and ensure Quality support in assigned projects with a high level of autonomy and expertise Ensure definition and compliance of the quality requirements Ensure the follow-up of the projects for which he/she is responsible with his/her manager and ensure alignment with Pharm Dev Quality Department managers Communicate appropriately within Pharm Dev team (e.g. clinical supply chain, analytical) and CMC project leaders Quality System
Contribute to identify quality processes and related documentation needs for his/her scope ensuring the appropriate interface within global Pharm Dev QMS Ensure appropriate change management internally or externally (analytical and/or chemical): monitoring, follow-up, records in Quality system, impact evaluation on the drug substance and drug product teams Monitor Quality performance of local organization: Quality metrics data collection, targets definition, best practices promotion, improvement initiatives support, and appropriate reporting to Global Pharm Dev Quality Support the coordination of the local and Global Pharm Dev quality management review in conjunction with global Pharm dev Quality Management System Develop & provide cGMP & GDP SOP training in interface within global Pharm Dev QMS to support particularly clinical supply chain teams Management
Direct consultants on complex projects Act as a subject matter expert and company representative during partner due diligence activities and regulatory inspections Perform regulatory compliance of regulatory filings (IND, IMPD) Oversee generation and review of documents used in cGMP & GDP activities such as Quality Agreements Audits
Contribute to regulatory authority inspections, partner audits or Ipsen Corporate audits as quality experts Knowledge & Experience
Bachelor’s Degree or equivalent in a scientific or technical discipline of relevance Proven direct experience in the regulated pharmaceutical industry, specifically including Quality Assurance, Quality Control, CMC development and/or Manufacturing Operations for Biological products Solid working knowledge of regulatory requirements (FDA, ICH, EMA) including GxP principles Knowledge & Experience (preferred)
Knowledge and experience of monoclonal antibody and/or antibody drug conjugate CMC development is desirable Demonstrated experience working with third party manufacturing contractors is desirable Language(s) (essential)
Fluent written and spoken English This job is eligible to participate in our short-term incentives program. Ipsen provides a comprehensive employee benefits package including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, and other well-being benefits. Seniority level
Not Applicable Employment type
Full-time Job function
Quality Assurance Industries
Pharmaceutical Manufacturing We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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Quality Assurance Manager
role at
Ipsen Ipsen is looking for a Quality Assurance Manager to play a pivotal role in driving the development and optimization of biologics, neurotoxins, small molecules, and medical devices within the Global Pharmaceutical Development organization, which includes three European sites and one US site. Your contributions will support Ipsen's strategy to become a center of excellence in pharmaceutical development and will directly influence our ability to deliver high-quality, effective treatments to patients worldwide. Responsibilities
Manage from a Quality point of view on assigned projects, the production, documentation and review of formal stability batches, and batches of drug substance and investigational medicinal products intended for internal or subcontracted clinical trials to guarantee the conformity of the products with the appropriate reference documents Approve the documents necessary for the manufacture and release of batches such as Product Specification Files, Master Batch Records, Supply Chain flow diagram, associated documents (instructions, forms, development protocol/report, etc.), formal stability batches and clinical batches for drug substance and drug product Ensure the management of changes for assigned projects according to the procedures in place Manage from a Quality point of view the release of assigned products intended for clinical GMP trials and non-clinical GLP trials Handle Quality events (deviations, OOS, change control, complaints, CAPA), associated with development studies and products for non-clinical GLP and clinical trials i.e. conduct and/or evaluate investigations related to Quality events and ensure the implementation of corrective and preventive measures Anticipate and alert on any Quality issue that may impact on the Quality of products, the availability of products for clinical trials or the progress of projects Check that the transport conditions (temperature excursions) of products intended for clinical trials guarantee their proper conservation Ensure that assigned complaints are handled in accordance with procedures and within the required timeframe Inform in a timely manner the escalation of any deviation or major or critical complaints to the direct manager or the VP Quality Pharmaceutical Development Support the Quality decisions by providing the necessary information and recommendations. Contribute to the preparation and conduct of QSEBs Assist with mock recalls, contribute to batch recalls Ensure the implementation and compliance with procedures and instructions related to activities in his/her area of responsibility Manage Quality activities and relationships with CDMOs and service providers for assigned projects. Manage their upgrading on operational quality aspects (e.g., COAs, analytical validations/transfers, process validations, master & executed batch records, label proofs, specifications, executed batch record review and batch disposition of Drug Substance, Drug Product and Finished Products (oral solid dosage forms, parenteral, radio labeled materials)) Quality Support for Projects Development
As Quality representative in development projects CMC cross functional workstream, act as key partner and ensure Quality support in assigned projects with a high level of autonomy and expertise Ensure definition and compliance of the quality requirements Ensure the follow-up of the projects for which he/she is responsible with his/her manager and ensure alignment with Pharm Dev Quality Department managers Communicate appropriately within Pharm Dev team (e.g. clinical supply chain, analytical) and CMC project leaders Quality System
Contribute to identify quality processes and related documentation needs for his/her scope ensuring the appropriate interface within global Pharm Dev QMS Ensure appropriate change management internally or externally (analytical and/or chemical): monitoring, follow-up, records in Quality system, impact evaluation on the drug substance and drug product teams Monitor Quality performance of local organization: Quality metrics data collection, targets definition, best practices promotion, improvement initiatives support, and appropriate reporting to Global Pharm Dev Quality Support the coordination of the local and Global Pharm Dev quality management review in conjunction with global Pharm dev Quality Management System Develop & provide cGMP & GDP SOP training in interface within global Pharm Dev QMS to support particularly clinical supply chain teams Management
Direct consultants on complex projects Act as a subject matter expert and company representative during partner due diligence activities and regulatory inspections Perform regulatory compliance of regulatory filings (IND, IMPD) Oversee generation and review of documents used in cGMP & GDP activities such as Quality Agreements Audits
Contribute to regulatory authority inspections, partner audits or Ipsen Corporate audits as quality experts Knowledge & Experience
Bachelor’s Degree or equivalent in a scientific or technical discipline of relevance Proven direct experience in the regulated pharmaceutical industry, specifically including Quality Assurance, Quality Control, CMC development and/or Manufacturing Operations for Biological products Solid working knowledge of regulatory requirements (FDA, ICH, EMA) including GxP principles Knowledge & Experience (preferred)
Knowledge and experience of monoclonal antibody and/or antibody drug conjugate CMC development is desirable Demonstrated experience working with third party manufacturing contractors is desirable Language(s) (essential)
Fluent written and spoken English This job is eligible to participate in our short-term incentives program. Ipsen provides a comprehensive employee benefits package including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, and other well-being benefits. Seniority level
Not Applicable Employment type
Full-time Job function
Quality Assurance Industries
Pharmaceutical Manufacturing We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr