391528BR
May 10, 2024
Slovenia
About the Role
We are seeking a Site Quality Head who will inspire and empower the team to reach new heights of success, by recruiting and developing a complete quality organization to support the ramp up, and Health Authority approval of a state of the art Aseptic Filling manufacturing facility. By nurturing talent and fostering a positive work environment, you can unlock your team's full potential.
To ensure the delivery of top-notch products and services, the development and implementation of robust quality assurance processes and quality control systems are paramount. By adhering to legislation, internal regulations, and industry best practices, you can instill trust in your customers and stakeholders. These processes act as a safety net, guaranteeing that every release activity meets the highest standards of quality and reliability.
You can drive success while staying true to legislation, internal regulations, good practices and business objectives. Embrace these pillars and watch as your organization thrives in an increasingly competitive landscape.
This role will work directly with the Global Quality Platform team and will report to the Global Quality Platform Head.
Key Responsibilities:
• Leadership of Site Quality organization and Quality oversight of GxP site functions.
• Acts as site Technical Responsible Person (Qualified Person), as appropriate.
• Established an organization that can develop site quality risk assessments and ensure DI, eCompliance and compliance with all cGxP and all regulatory requirements for manufacturing, control and distribution operations.
• Drives the talent agenda: leads people processes through recruitment, training, coaching and performance to meet all operation requirements sustaining both site and quality unit competitiveness and diversity. Supports a robust career path deployment and succession plan for the unit and site.
• Ensure that associates are qualified for a GMP task prior to independent performance.
• Role model the culture aspiration of being Curious, Inspired and Unbossed and ensure leaders and associates are aware and aligned on expectations and hold them accountable for success of culture journey.
• Ensure overall inspection readiness for area of responsibility.
• Being part of the site crisis management team and depending on skills, expertise and experience can be appointed to one of the NEM roles (Novartis Emergency Management). By delegation of the Site Manager may be required to take decisions and take the necessary actions, in particular within the framework of the on-call management system.
To ensure the delivery of top-notch products and services, the development and implementation of robust quality assurance processes and quality control systems are paramount. By adhering to legislation, internal regulations, and industry best practices, you can instill trust in your customers and stakeholders. These processes act as a safety net, guaranteeing that every release activity meets the highest standards of quality and reliability.
You can drive success while staying true to legislation, internal regulations, good practices and business objectives. Embrace these pillars and watch as your organization thrives in an increasingly competitive landscape.
This role will work directly with the Global Quality Platform team and will report to the Global Quality Platform Head.
Key Responsibilities:
• Leadership of Site Quality organization and Quality oversight of GxP site functions.
• Acts as site Technical Responsible Person (Qualified Person), as appropriate.
• Established an organization that can develop site quality risk assessments and ensure DI, eCompliance and compliance with all cGxP and all regulatory requirements for manufacturing, control and distribution operations.
• Drives the talent agenda: leads people processes through recruitment, training, coaching and performance to meet all operation requirements sustaining both site and quality unit competitiveness and diversity. Supports a robust career path deployment and succession plan for the unit and site.
• Ensure that associates are qualified for a GMP task prior to independent performance.
• Role model the culture aspiration of being Curious, Inspired and Unbossed and ensure leaders and associates are aware and aligned on expectations and hold them accountable for success of culture journey.
• Ensure overall inspection readiness for area of responsibility.
• Being part of the site crisis management team and depending on skills, expertise and experience can be appointed to one of the NEM roles (Novartis Emergency Management). By delegation of the Site Manager may be required to take decisions and take the necessary actions, in particular within the framework of the on-call management system.
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:
• Minimum 10 years experience in the field of quality, development or production.
• University degree in Pharmacy, Chemistry, or another natural science.
• Functional knowledge of English and working language of Slovenian.
• Ability to function within ambiguity.
• Cross functional collaboration.
• Aseptic processing knowledge / experience.
• Proven performance in Health Authority inspections.
We offer permanent employment, with 6 months of probation period.
You are kindly invited to submit your application in English language, including CV by 24th of May 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, Pension scheme, Employee Recognition Scheme, Expanded program for the promotion of health in the field of physical, mental and social well-being, 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
• Minimum 10 years experience in the field of quality, development or production.
• University degree in Pharmacy, Chemistry, or another natural science.
• Functional knowledge of English and working language of Slovenian.
• Ability to function within ambiguity.
• Cross functional collaboration.
• Aseptic processing knowledge / experience.
• Proven performance in Health Authority inspections.
We offer permanent employment, with 6 months of probation period.
You are kindly invited to submit your application in English language, including CV by 24th of May 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, Pension scheme, Employee Recognition Scheme, Expanded program for the promotion of health in the field of physical, mental and social well-being, 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
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Operations
QUALITY
Slovenia
Ljubljana
NVS Farmacevtska Proi. doo
Quality
Full Time
Regular
No
