Global ESO Analytical Science & Technology (AS&T) Lead (m/f/d)

Novartis Technical Operations
Division Novartis Technical Operations
Geschäftseinheit NTO QUALITY
Standort Holzkirchen (near Munich)
Funktionsbereich Quality
Art der Stelle Vollzeit
Anstellungsverhältnis Regular
StellenID 264697BR


Stellenbeschreibung

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

Optional locations: Holzkirchen (Germany), Kundl (Austria) or Ljubljana (Slovenia)



Quality


Mindestanforderungen

• 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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