Global Quality Product Manager
4 semanas atrás
Gr?Nenthal Gmbh is seeking a highly skilled Global Quality Product Manager to join our team. As a key member of our Global Operations & Production department, you will be responsible for ensuring the highest standards of quality in our products.
Key Responsibilities:- Planning, defining, and maintaining the regulatory CMC quality section for our product portfolio worldwide.
- Providing critical assessment and strategic input on quality-related matters, flagging risks, and proposing mitigations to maximize chances of success for approval.
- Developing global regulatory CMC strategies for active substances and finished products in collaboration with internal and external stakeholders.
- Ensuring Regulatory Compliance of our product portfolio, including management of Product Change Control and review of GMP Master documentation.
- Providing advice to Gr?Nenthal manufacturing sites, suppliers, and customers/partners on CMC regulatory requirements, considering national and international regulatory standards.
- Supporting transfers and preparation of Technical Agreements with manufacturing sites, affiliates, and suppliers to ensure regulatory compliance.
- Compilation of Product Quality Review Annex 5B.
- Supporting due diligence and partnering activities as assigned.
- Take-over of project-oriented special tasks.
- Degree as a Pharmacist or another natural scientist.
- Profound experience in regulatory CMC for NCEs, knowledge on Medical devices (Drug product combinations) is beneficial.
- Proven track record in QA and/or GMP environment and in-depth knowledge of relevant national and international guidelines and regulatory requirements for e.g. US, EU, Japan, and rest of the world (RoW).
- Experience in critically reviewing detailed scientific information to ensure information is thoroughly assessed, presented clearly, and supported by data.
- Demonstrate ability to build and maintain influential relationships with internal and external stakeholders to convey and exchange information.
- Decision making also in challenging situations.
- Strong oral and written communication skills, especially in English; another language would be a plus, preferably German.
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Global Quality Product Manager
4 semanas atrás
Lisboa, Lisboa, Portugal Gr?Nenthal Gmbh Tempo inteiroGlobal Quality Product ManagerGr?Nenthal Gmbh is seeking a highly skilled Global Quality Product Manager to join our team. As a key member of our Global Operations & Production department, you will be responsible for ensuring the highest standards of quality in our products.Key Responsibilities:Develop and implement global regulatory CMC strategies for...
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Global Quality Product Manager
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Global Quality Product Manager
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Lisboa, Lisboa, Portugal Grünenthal Tempo inteiroGlobal Quality Product ManagerGrüenthal is seeking a highly skilled Global Quality Product Manager to join our team. As a key member of our Global Operations & Production department, you will be responsible for ensuring the highest standards of quality in our products.Key Responsibilities:Planning, defining, compiling, revising, and maintaining the...
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Global Quality Product Manager
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Lisboa, Lisboa, Portugal Gr?Nenthal Gmbh Tempo inteiroGlobal Quality Product ManagerGr?Nenthal Gmbh is seeking a highly skilled Global Quality Product Manager to join our team. As a key member of our Global Operations & Production department, you will be responsible for ensuring the highest standards of quality in our products.Key Responsibilities:Plan, define, compile, revise, and maintain the regulatory CMC...
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Lisboa, Lisboa, Portugal Gr?Nenthal Gmbh Tempo inteiroGlobal Quality Product ManagerGr?Nenthal Gmbh is seeking a highly skilled Global Quality Product Manager to join our team. As a key member of our Global Operations & Production department, you will be responsible for ensuring the highest standards of quality in our products.Key Responsibilities:Plan, define, compile, revise, and maintain the regulatory CMC...
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