MU & MST Lead

Major accountabilities:

Drive Site Product Transfer, Technical Readiness and Ramp-Up

·       Accountable for end-to-end technical transfer and lifecycle management of products and processes, ensuring regulatory readiness and sustainable commercial manufacturing

·       Lead the steward team to ensure technical governance and technical stewardship, ensuring compliant change control, robust CMC readiness, and establishment of GMP-compliant processes and control strategies

·       Accountable for validation excellence, inspection readiness, and process robustness, ensuring successful product launch, ramp-up, and reliable supply performance

Drive Site Manufacturing Unit Performance Achievement

·         Develop and implement site operational readiness plan mainly focus on MU establishment and routine products supplying on time in full.

·         Develops and follows-up the medium and long term strategy for department in connection with the site strategy in order to guarantee profitability and meets the needs of the site and the company, in accordance with the strategic vision of the site and Novartis Technical Operations

·         Ensures overall financial and business performance, safety, quality, costs, supply and resource management (people, equipment, facilities, etc.) and represent this in the site leadership team

·         Ensure the efficient distribution of the Unit's resources (CAPEX, OPEX, expenses, FTEs).

·         Builds/sustains strong network in and outside the organization and with the Operations Centers

Change and Transformation Leadership

·         Develop and implement strategy within manufacturing unit aligned with RLT and TechOps strategy

·         Oversee all site manufacturing operations

·         Be accountable for resource  planning and allocation for manufacturing site and  project execution

·         Ensure optimal collaboration and synergies among various functions and units to continuously improve internal processes and seamlessly fulfill business objectives

·         Responsible for implementation of and compliance to the principles and practices of Novartis manufacturing standards

·         Role model values. Be a learner, not a knower. Be clear, present and focused

·         Develop trusting and respectful relationships

·         Manage your energy and impact

·         Sets performance targets for the Manufacturing Unit in line with business objectives and develops long-term plan in line with global and site strategy

·         Engages and motivates the team and delivers strong results with an empowered team

·         Creates environment of trust, assures clarity and open two-way communication, and fosters a speak-up mentality

Knowledge and Development of Talent and Pipeline

·         Drives the talent agenda: Leads people processes through recruitment, training, coaching and performance to meet all operation requirements sustaining both site and manufacturing unit competitiveness and diversity. Supports a robust career path deployment and succession plan for the unit and site

·         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

·         Develop the organization in accordance with NTO principles

·         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

Active Culture Building

·         Create a work environment that enables high employee engagement

·         Sponsor execution of culture plan (including HSE, Quality, OpEx, Leadership aspects) for the manufacturing site, ensure leaders and associates are aware and aligned on expectations and hold them accountable for success of culture journey

·         Role model the culture aspiration of being Curious, Inspired and Un-bossed

Quality and HSE

·         Guarantee the conformity of the manufacturing unit activities with regard to GMP and HSE rules, Novartis quality/safety policies, and the standards and quality/safety procedures

·         Promote and improve the Safety and Quality cultures, by implementing the necessary systems and actions in line with the evolution of the site

·         Ensure overall inspection readiness for area of responsibility.

·         Guarantee the effectiveness of the Business Continuity Plan

·         Be responsible for the implementation, compliance and governance of the practices explicitly defined in their role by the "Novartis Manufacturing Manual"

·         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.

·         Responsible for participating in initial training and retraining Digital Curiosity

·         Explore the potential of data and technology to support transformation journey of the manufacturing site in-line with NTO strategy

·         Encourage others to learn about and leverage data and technology

Operational Excellence, continuous improvement and COGS competitiveness

·         Sponsor continuous improvement initiatives via Manufacturing Science & Technology, Lean manufacturing, 6 Sigma to increase the site performance against current and future business objectives

·         Lead the LEAN philosophy of innovation / Quality / productivity (LEAN IQP) within the Unit and guarantees the continuous improvement of the whole process.

·         Define the operational improvement policy/strategy and establish the portfolio of continuous improvement projects and prioritize improvement actions based on available resources

·         Ensure the progress and sustainability of the results obtained

·         Manage module-related financial and operational drivers underpinning superior performance

·         Sponsor OpEx initiatives in the manufacturing site

Key Performance：

·         Achieve plant KPIs

·         Technical transfer milestones achieved in time and in full. Including schedule for registration and launches.

·         Robust manufacturing process, delivering critical quality attributes.

·         Service level (no stock-out / no delay in production)

·         Costs control and competitiveness

·         Number of customer complaint on quality, cost of poor quality

·         success rate of HAs inspections

·         Right first time (Right First Time (RFT))

·         Number of overdue compliance activity, effective CAPAs

·         Launch performance on time

·         P&O: Satisfaction survey, execution of talent and development plans, technical training program in place and executed, training data, attracting and retaining talent, succession plan for Manufacturing unit in place and robust

·         HSE : Work accident rate, presence of the manager, success rate of inspections, reduction of waste, efficiency

·         OpEx: Productivity Improvements