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QA Compliance & Operations Lead, RLT CN

Novartis

Novartis

Legal, Operations, Quality Assurance
China
Posted on Thursday, February 1, 2024

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