Job Description

Summary -Global Head of MSAndT-Platform, Head Global Packaging And Devices NTO -Leads the MSAndT organization globally or regionally, which is responsible to maintain and improve the scientific oversight of the manufacturing processes and technical changes, the relevant technical knowledge, and capabilities at the platform and to ensure the product and technical stewardship, across process units and functions at platform. -May also lead a global sub-function of MSAndT which is cross-divisional in scope and will oversee all aspects of the MSAndT sub-function across multiple platforms. -Site MSAndT Head-Large Site -Leads the Site's MSAndT organization, which is responsible to maintain and improve the scientific oversight of the manufacturing processes and technical changes, the relevant technical knowledge, and capabilities at the Site and to ensure the product and technical stewardship, across process units and functions at Site. -Global Technical Steward -Product Steward: Ensures oversight of product(s) related technical process(as) and quality aspects, end to end throughout the supply chain and across multiple sites, to maintain and improve product process capability, quality, and compliance. -TTL: Responsible at platform level to define the procedures and processes for successful implementation of product technical transfers either from development to production or between production sites. -Stats Lead: Provide leadership on the development and deployment of statistics strategy for the manufacturing network. -Val Led: Responsible for developing, implementing and managing the platform process validation, primary packaging validation, cleaning validation and revalidation strategies to meet cGMP and quality requirements on time and on budget to ensure that programs are compliant with Regulatory Authorities' expectations and related SOPs. -Tech Steward: Provides to the Platform the specialist knowledge and expertise, as Subject Matter Expert of specific pharmaceutical processes or process technologies.

Key Responsibilities:

• Site MSAndT Head-Large Site, Global Technical Steward -Leadership: set objectives and develops vision for department; act as SPOC for site head and MSAndT platform/ cluster head; manage the MSAndT career path, succession planning, training program and career progression within the site; enable knowledge management for processes and products within department and across site functions; define and implement standards for MSAndT; works with the other Site MSAndT teams and networks of the relevant platform/cluster.
• Stewardship: ensure that quality and compliance improvement and savings opportunities are rapidly re-applied globally; ensure robust product stewardship for all products manufactured at the site, And end-to-end technical oversight of product manufacturing processes, at all stages of their commercial lifecycle -Ensure that all products, processes, unit operations are assigned to a product steward / technical steward / process expert / packaging expert -Ensure that all manufacturing processes are robust respectively process improvement projects -Works across PUs and Functions within the Site and in close collaboration with MSAndT global team to resolve issues and to ensure process capability -Ensure oversight of technical changes and lead end-to-end change control management related to relevant technical issues, working cross-functionally as required -Acts as the interface for the site with the relevant Health Authorities for technical issues -Reviews and releases regulatory proposals or information required for regulatory filings -Validation: ownership of the site Validation Master Plan (VMP) (creation and maintenance); ensure that execution of VMP activities is tracked; ensures all manufacturing, packaging, and cleaning processes are validated and ongoing verification is implemented, so that all site products are validated and remain in constant state of validation throughout the product lifecycle.
• Launch And Transfer: accountable for technical transfer activities into, within and out of the site; work with technical research and development organizations to ensure a robust commercial scale-up of new products.
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt.
• Distribution of marketing samples (where applicable).
• Global Head of MSAndT-Platform, Head Global Packaging And Devices NTO -Leadership: act as SPOC for all MSAndT related topics; set objectives and develops vision for MSAndT organization of platform / cluster; manage the MSAndT talent pipeline through career path, succession planning, training program and career progression within platform / cluster; enable knowledge management for processes and products across sites; define and implement standards for MSAndT.
• Stewardship: ensure robust product stewardship for all products manufactured at the platform / cluster, and end-to-end technical oversight of product manufacturing processes, at all stag

Essential Requirements:

• MS&T processes and procedures implemented on time and quality.
• Success rate internal/external quality bodies inspections -Success rate of Health Authorities inspections -Technology transfers and new product launches on time, right first time.
• Technical training program in place and executed.

Desirable Requirements:
Work Experience:

• Leading large and/or diverse multi-functional teams.
• Functional Breadth.
• Cross Cultural Experience.
• Operations Management and Execution.
• Collaborating across boundaries.
• People Leadership.

Skills:

• Change Management.
• Manufacturing (Production).
• Manufacturing Process Science.
• Manufacturing Technologies.
• Process Control.
• Process Simulation.
• Project Management.
• Quality Compliance.
• Technical Leadership.

Languages:

• English.

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: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
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.
Skills Desired Change Management, Manufacturing Process Science, Manufacturing Production, Manufacturing Technologies, Process Control, Process Simulation, Quality Compliance, Technical Leadership, Waterfall Model

Skills Required