About the Role
Location: Mengeš #LI-Hybrid
Join highly connected team of excellent quality experts as Senior Quality Manager and collaborate with other teams in building and operationalizing the unique development GMP production and research center called Biocampus Mengeš within the Biological Drug Development Mengeš. From this new production location, we will supply patients with innovative drugs for early-phase clinical studies I and II.
Key Responsibilities:
• Support a discipline and/or provide a service individually or within a team of associates. May provide functional expertise to Line Unit and other QA Units in area of responsibility.
• Write, review, decide on approval and/or release of GMP-relevant deliverables and or/ related tools as per area of responsibility in order to ensure compliance with cGMP and project quality deliverables.
• Manage project related activities (e.g. TRD product portfolio, development of new tools, processes, Quality initiatives, Quality Manual implementation, Quality Plans, Quality Risk Assessments, training activities, qualification and facility upgrade activities, IT validation projects) as per area of responsibil-ity.
• Support Project management functions as a project team member.
• Provide support to TRD line functions in GMP related topics as per area of responsibility.
• Comply with internal and external guidelines regarding quality and safety (Quality Manual, regulatory cGMP guidelines, Health Authority guidance, SOPs etc.).
Diversity & Inclusion / EEO
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements
Essential Requirements:
• Masters degree in life sciences (Microbiology, Pharmacy, Biotechnology, Biochemistry or similar).
• Fluent English required (spoken & written). Good skills in local language desired.
• Minimum 4 years of experience in pharma quality or technical operations.
We offer permanent employment, with 6 months of probation period.
You are kindly invited to submit your application in English language, including CV by 9th of January 2024.
Why Novartis?
Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You'll receive:
Competitive salary, Annual bonus, Flexible working schedule, tailored to your needs, possibility to work from home, Pension scheme, Employee Recognition Scheme, Expanded program for the promotion of health in the field of physical, mental and social well-being (Energized for Life), employment at Top SI Employer, Unlimited learning and development opportunities.
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Division
Development
Business Unit
QA GDD
Location
Slovenia
Site
Menges
Company / Legal Entity
NVS Farmacevtska Proi. doo
Functional Area
Quality
Job Type
Full Time
Employment Type
Regular
Shift Work
No