Job Description

Summary -This is a universal job description meant to capture some of the primary duties of this role that are common across functions or divisions. It is not intended to represent all of the specific responsibilities of the position -Management TrackLead and manage the Engineering, Logistics and Safety Experts team inthe Local Supply Center to ensure deliveries of intermediates anddrug substance, maintaining compliance with internal and externalregulatory and quality standards(GMP and HSE) and budget targets.Responsible for maintenance and investment budgets and long terminvestment plan for DSS.TRD Representative for Engineering for Rhinetal Valley. -Scientific / Technical TrackHas operational end to end responsibility for assigned supply activities. Leads and manages complex and demanding projects and global network activities and participates in cross-functional teams. Accountable for performance improvement initiatives. -Produces, packages and manufactures drugs to be used in clinical trials. Responsible for distribution, warehousing, transportation, packaging, randomization, blinding, and labeling of material for clinical trials in conformity with guidelines of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP). -To oversee clinical supply on holistic global trials level, proactively negotiates and communicates clinical supply plan/timeline to internal and external customers and partners.

Major accountabilities:

• Management Track.
• Lead projects or campaigns or proactively drive project execution.
• Set key milestones and /or ensure project progress, quality and budget adherence.
• Act as unit representative on or lead development teams and/or other cross functional teams.
• Ensure governance process is in place to be compliant to Novartis and other relevant regulations.
• Writing and reviewing of SOPs.
• Coaching senior associates in technical and leadership area.
• Act as mentor for senior associates globally.
• Perform role of facilitator/mediator in difficult scenarios.
• Provide strong input into OTR process and Talent Management.
• In close cooperation with the Unit Head, drive the unit long term strategic plan and its implementation.
• Ensure current and future needs are fully met, unit projects are assigned, adequately resourced, delivered on time and in full compliance.
• Manage resource constraints and lead cost saving opportunities.
• Being accountable for a large budget (Project, infrastructure, plan maintenance).
• Scientific Track.
• Coordinates internal and external stakeholders, customers and /or vendors and performs stakeholder management.
• Lead projects or campaigns or proactively drive project execution.
• Set key milestones and/or ensure project progress, quality and budget adherence.
• Act as unit representative on or lead development teams and/or other cross functional teams.
• Communicate issues to teams and line management in a proactive way and propose corrective actions and mitigation plan.
• Organize and ensure regular lessons learned sessions and follow up on actions.
• Coaching and technical training as recognized technical expert or leader.
• Act as mentor for junior and senior associates (academics) globally.
• Perform role of facilitator / mediator in difficult scenarios.
• Understand resource constraints and identify and lead cost saving opportunities.
• Being accountable for a medium budget (Project, infrastructure, plan maintenance).
• Ensure own and other team members' compliance to Novartis and other relevant regulations.
• Writing and reviewing of SOPs.
• Consolidate data evaluation and propose solutions / risk mitigation plans -Act as role model for cultural evolution within TRD.
• Being accountable for global process improvement as leader or member.
• Drive implementation and sustain phase in and outside expertise / organization.
• Oversees clinical supply projects on holistic global trials level, proactively negotiates and communicates clinical supply plan/timeline to internal and external customers and partners.
• Reviews clinical trial protocol and provides input to drug sections.
• Develops packaging design matching the study design, which ensures optimized supply plan in terms of cost, feasibility and overage for own studies and guides and coaches other Trial managers regarding best possible design.
• Applies simulation tools to drive optimal clinical supply plan, adequately supports studies.
• Drives the development and use of simulation technique with ex

Key performance indicators:

• Management Track -Drive the planning, coordination, and execution of all people management processes in the unit, including performance management, training, and development planning.
• Partner with the Development and Education Office (DEO) to identify and devise unit training opportunities, addressing both strategic and behavioral needs while taking into account suitable metrics to quantify training success.
• Drive a culture of excellence in knowledge sharing.
• Provide strong input into OTR process and Talent Management.
• Develop, monitor, and report on Key Performance Indicators (KPI) and performance measures to enable strategic objectives to be met, or corrective action to be taken.
• Permanent measurement, benchmarking, and continuous improvement of KPI for the unit.
• In close cooperation with the Unit Head, drive the unit long term strategic plan and its implementation.
• Ensure current and future needs are fully met, unit projects are assigned, adequately resourced, delivered on time and in full compliance.
• Scientific / Technical Track.
• Quality (GMP), quantity, and timelines for all assigned tasks/projects.
• Compliance with Novartis standards, in particular, ethics, health, safety, and environment (HSE), and information security (ISEC) standards.
• Unit KPIs (e.g. FPFV (first patient first visit), LTA (lost time accident), FTR (first time right), Rework Rates, Recalls).
• Cross functional and TRD KPIs .

Minimum Requirements:
Work Experience:

• Collaborating across boundaries.
• Representing the organization.
• People Leadership.
• 8 plus years of relevant experience.

Skills:

• Continual Improvement Process.
• Master Data.
• Material Requirements Planning (Mrp).
• Materials Management.
• People Management.
• Production Planning.
• Project Management.
• Supplier Relationship Management (Srm).
• Supply Chain Planning.
• Supply-Chain Management.
• Technical Requirements.
• Wms (Warehouse Management Systems).

Languages :

• English.

Skills Desired Continual Improvement Process, Master Data, Material Requirements Planning (Mrp), Materials Management, People Management, Production Planning, Supplier Relationship Management (Srm), Supply-Chain Management, Supply Chain Planning, Technical Requirements, Waterfall Model, Wms (Warehouse Management Systems)

Skills Required