Global Quality Product Manager

4 semanas atrás

Lisboa, Lisboa, Portugal Grünenthal Tempo inteiro

Job Overview

Grünenthal 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 regulatory CMC quality section for the supervised product portfolio worldwide.
  • Providing critical assessment and strategic input, flagging risks, proposing mitigations as well as highlighting opportunities for Grünenthal for the quality part of dossiers to maximize chances of success for approval.
  • Proactively developing, in cooperation with internal and external stakeholders, the global regulatory CMC strategies for active substances and finished products.
  • Ensuring Regulatory Compliance of the supervised product portfolio including but not limited to management of Product Change Control and review of GMP Master documentation.
  • Providing advice to Grünenthal manufacturing sites, suppliers, and customers/partners regarding CMC regulatory requirements considering national and international regulatory standards.
  • Support in transfers and in preparation of Technical Agreements with manufacturing site, affiliates, and suppliers in order to assure regulatory compliance.
  • Compilation of Product Quality Review Annex 5B.
  • Supporting due diligence and partnering activities as assigned.
  • Take-over of project-oriented special tasks.

Requirements

  • Degree as a Pharmacist or as another natural scientist.
  • Profound experience in regulatory CMC for NCEs, knowledge of 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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