Global ESO Analytical Science & Technology (AS&T) Lead (m/f/d
Novartis AG
Holzkirchen (near Munich), Germany
vor 17 Tg.

Job Description

The Global ESO AS&T Lead is accountable for implementing and maintaining the ESO AS&T quality system incl. tools & processes.

He / she leads the Global ESO AS&T network and represents ESO within cross-divisional QC and AS&T working groups and project teams of broader scope.

He / she acts as SPOC for NTO AS&T to delegate and coordinate to the network located AS&T Experts.

Main tasks :

  • Defines and implements processes and SOPs to maintain a robust QC, stability and AS&T Quality System within ESO
  • Leads the ESO AS&T Network (dotted line accountability)
  • Represents ESO within cross-divisional QC and AS&T working groups and project teams of broader scope. Leads and manages major and complex platform-
  • wide AS&T programs and projects

  • Supports the network located AS&T Experts in identifying, qualifying and managing Con-tracted Laboratories to assure compliance with cGMP
  • SPOC for the Contract Lab ESO QAA template. Supports the negotiations to establish a QAA with contract labs, in case required
  • Coordinates the Testing Monographs Assessment program with PLS and the network based AS&T Experts. Accountable for the TM Assessment process at PLS
  • Ensure that Stability Programs are state-of-the-art with respect to HA requirements and in line with global guideline. Is owner of the ESO Stability Process and represents ESO in the NTO Stability Network
  • Provide training on process and tools, as required
  • Author SOPs defining the quality processes for managing External Suppliers. Monitoring per-formance against Novartis Quality Standards
  • Support site readiness for self-inspections, internal audits, GCA and HA audits
  • Participate in audits of Contract labs on request
  • Act as deputy for the Global Head ESO QA Operations
  • Minimum requirements

  • Higher university degree (e.g. Ph.D.) in Biochemistry, Chemistry or another related science
  • 5 10 years working experiences in a cGMP environment
  • Minimum 5 years experiences in Pharmaceutical Quality Control or analytical method development
  • Thorough knowledge of regulatory requirements & risk management
  • Thorough technical knowhow of DS and / or DP release and stability testing
  • Fluent in speaking and writing in English
  • Good leadership skills and experiences in leading teams in a challenging environment
  • Strong track record in project management
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