Finance controller manager állások, munkák minőségbiztosítás kategóriában

Global Market Access Manager The Global Market Access Manager will play a key role in enabling timely, sustainable patient access to mylife Diabetes care AID therapy across global markets. The mission of the role is to shape and execute the global market access strategy by anticipating payer,...

Develop, maintain, and continuously improve the quality assurance framework applicable to embedded labs, aligned with Nelson Labs global quality policies and Sterigenics QMS....

A cég által gyártott életmentő, illetve életminőséget javító orvosi berendezések, dialízisgépek fejlesztésében való részvétel Tesztstratégia kialakítása és folyamatos fejlesztése a termékvonal számára Tesztelési folyamatok, eszközök és módszertanok definiálás, a vonatkozó szabványok...

(Associate) Bioanalytical Principal Investigator LBS (100%) Celerion is one of the world's leading bioanalytical contract research companies and has been supporting pharmaceutical and biotech companies around the world for more than 40 years. Celerion offers services for the approval of new drugs -...

Lead Expert Quality Assurance, Deputy Responsible Person 40% Become part of a vital chain and contribute to our common goal of making people’s lives better. Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing...

• Planning and initiation of business cases, definition of the project scope, objectives and deliverables. This includes gathering requirements, assessing feasibility and developing a project plan that aligns with organizational goals
• Monitoring of timelines and budget

Management of safety operations incl. corresponding service providers, creation and maintenance of reporting rules (in collaboration with the department Global Safety Application Management) and license partner obligations with respective compliance outputs (e.g. KPIs, PSMF)...

• Cover the PRRC role when requested from the needs of the company (e.g. during the absence of the current PRRC)
• Develop and execute regulatory strategies for products and services
• Provide regulatory expertise for complex or unique issues and challenges regarding registration and compliance activities.

• Provide direct line management for >10 CP Delivery Managers embedded across drug programs and AI/ML model development initiatives
• Build delivery capability through coaching, role clarity, performance management, and career development

• Global pharmacovigilance product responsibility for the medicinal products
• Monitoring of the benefit-risk profile
• Signal management: signal detection, signal validation, signal evaluation
• Risk management: preparation of risk management plans, supervision of risk minimization measures

• Confirms, certifies, and releases batches of products manufactured, ensuring all manufacturing steps have been performed in compliance with GMP, the marketing authorization of the relevant product, defined procedures, and current regulations.
• Confirms batches of products intended for clinical trials.

Az intézmény minőségirányítási rendszerének működtetése és fejlesztése Minőségügyi indikátorok, betegbiztonsági események és kockázatok elemzése Belső auditok szervezése és lebonyolítása Hatósági ellenőrzésekre és auditokra történő felkészülés koordinálása Minőségfejlesztési projektek irányítása és...