391304BR
Feb 01, 2024
China
About the Role
Location: Haiyan, Zhejiang
About the role:
To provide managerial leadership for the RLT project in all quality related matters and to ensure that key aspects of the operational business comply with cGMP and regulatory requirements as well as the key Novartis corporate quality policies. Role model with the Novartis leadership framework and cultural aspirations.
Key Responsibilities：
Operational
• Leadership of project Quality organization. Implement, comply with, and govern practices prescribed in the Novartis Manufacturing Manual. Quality oversight of GxP functions. Acts as Technical Responsible Person (Qualified Person)
• Ensure product quality; Ensure regulatory compliance and implementation of corporate quality standards and regulations; Ensure status of local HA registration; Preparation of Master File for regulatory purposes; Project quality risk assessment; Quality Management Review
• Approval or rejection of raw materials, facilities, utilities, preliminary, finished product or stability samples; Approval of PQR/APQR; Ensure exception management; Ensure complaint investigation; Ensure training execution across project; Ensure DI, eCompliance and compliance with all cGxP and all regulatory requirements for manufacturing, control and distribution operations; Ensure adherence to HSE guidelines and requirements.
• Collaboration in GxP internal audits; Ensure fulfillment of internal/external audit and inspection plans; Ensure any collaborations with 3rd parties are performed with adequate Quality Assurance Agreements in place; Ensure any additional local legal requirements are fulfilled; Ensure Business continuity management
Leadership & Culture
• Drives the talent agenda: Leads people processes through recruitment, training, coaching and performance to meet all operation requirements sustaining both project and quality unit competitiveness and diversity. Supports a robust career path deployment and succession plan for the unit and project; Invest time in personally developing and coaching talents; Actively support and promote talent exchange for the benefit of the individuals and organization; Ensure the consistency between career development processes and the business strategy
• Support the T&L organization by identifying and reviewing the appropriate list of training for all in-scope associates; Ensure that associates are qualified for a GMP task prior to independent performance; Monitor overall training compliance for in-scope associates; Identify and maintain a list of subject matter experts for in-scope areas of expertise
• Create a work environment that enables high employee engagement; Role model the culture aspiration of being Curious, Inspired and Un-bossed and ensure leaders and associates are aware and aligned on expectations and hold them accountable for success of culture journey
HSE
• Promote and improve the Safety and Quality cultures, by implementing the necessary systems and actions in line with the evolution of the project; Ensure overall inspection readiness for area of responsibility; Guarantee the effectiveness of the Business Continuity Plan; Being part of the project 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 project Manager may be required to take decisions and take the necessary actions, in particular within the framework of the on-call management system. Responsible for participating in initial training and retraining. HSE incidents reporting & action follow-up
About the role:
To provide managerial leadership for the RLT project in all quality related matters and to ensure that key aspects of the operational business comply with cGMP and regulatory requirements as well as the key Novartis corporate quality policies. Role model with the Novartis leadership framework and cultural aspirations.
Key Responsibilities：
Operational
• Leadership of project Quality organization. Implement, comply with, and govern practices prescribed in the Novartis Manufacturing Manual. Quality oversight of GxP functions. Acts as Technical Responsible Person (Qualified Person)
• Ensure product quality; Ensure regulatory compliance and implementation of corporate quality standards and regulations; Ensure status of local HA registration; Preparation of Master File for regulatory purposes; Project quality risk assessment; Quality Management Review
• Approval or rejection of raw materials, facilities, utilities, preliminary, finished product or stability samples; Approval of PQR/APQR; Ensure exception management; Ensure complaint investigation; Ensure training execution across project; Ensure DI, eCompliance and compliance with all cGxP and all regulatory requirements for manufacturing, control and distribution operations; Ensure adherence to HSE guidelines and requirements.
• Collaboration in GxP internal audits; Ensure fulfillment of internal/external audit and inspection plans; Ensure any collaborations with 3rd parties are performed with adequate Quality Assurance Agreements in place; Ensure any additional local legal requirements are fulfilled; Ensure Business continuity management
Leadership & Culture
• Drives the talent agenda: Leads people processes through recruitment, training, coaching and performance to meet all operation requirements sustaining both project and quality unit competitiveness and diversity. Supports a robust career path deployment and succession plan for the unit and project; Invest time in personally developing and coaching talents; Actively support and promote talent exchange for the benefit of the individuals and organization; Ensure the consistency between career development processes and the business strategy
• Support the T&L organization by identifying and reviewing the appropriate list of training for all in-scope associates; Ensure that associates are qualified for a GMP task prior to independent performance; Monitor overall training compliance for in-scope associates; Identify and maintain a list of subject matter experts for in-scope areas of expertise
• Create a work environment that enables high employee engagement; Role model the culture aspiration of being Curious, Inspired and Un-bossed and ensure leaders and associates are aware and aligned on expectations and hold them accountable for success of culture journey
HSE
• Promote and improve the Safety and Quality cultures, by implementing the necessary systems and actions in line with the evolution of the project; Ensure overall inspection readiness for area of responsibility; Guarantee the effectiveness of the Business Continuity Plan; Being part of the project 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 project Manager may be required to take decisions and take the necessary actions, in particular within the framework of the on-call management system. Responsible for participating in initial training and retraining. HSE incidents reporting & action follow-up
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:
• University degree in Pharmacy, Engineering, Chemistry, Biotechnology or equivalent
• 12-15 years’ experience in the field of Quality Assurance and Quality Control in a pharmaceutical industry environment or equivalent
• Operations Management and Execution, People Leadership, Collaborating across boundaries, Functional Breadth, Project Management, Financial Management, Industry/ Business Exposure
• Fluent oral and written in English and Mandarin
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
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf
Accessibility and Accommodation:
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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. You can follow us via Novartis Recruitment WeChat Official Account and Novartis Recruitment WeChat Video Account.
• University degree in Pharmacy, Engineering, Chemistry, Biotechnology or equivalent
• 12-15 years’ experience in the field of Quality Assurance and Quality Control in a pharmaceutical industry environment or equivalent
• Operations Management and Execution, People Leadership, Collaborating across boundaries, Functional Breadth, Project Management, Financial Management, Industry/ Business Exposure
• Fluent oral and written in English and Mandarin
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
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf
Accessibility and Accommodation:
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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. You can follow us via Novartis Recruitment WeChat Official Account and Novartis Recruitment WeChat Video Account.
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
SMALL MOLECULES
China
Jiaxing
Novartis Pharma Beijing
Quality
Full Time
Regular
No
