Clinical Supply Project Leader

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. -Has operational end to end responsibility for assigned supply activities. -Leads and manages projects of different complexity and local network activities and participates in cross-functional teams. -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). -Has operational end to end responsibility for assigned supply activity. Leads and manages demanding projects and network activities and participates in cross-functional teams.

Major accountabilities:

• Contributes as unit representative on project teams.
• Ensures that own deliverables are met.
• Interprets results, evaluates data, draws conclusions and reports back to team and management -Coordinates internal and external stakeholders, customers and/or vendors and performs stakeholder management -Proactively drive project execution to ensure key milestones and quality are met -Act as unit representative on development teams and/or other cross functional teams -Communicates issues involved stakeholders and to teams and line management and propose corrective actions -For GMP units: ensure compliance to cGMP -Organizes and ensures regular lessons learned sessions -Coaching and technical training as recognized technical expert or leader.
• Act as mentor for junior and senior associates (academics) also globally -Understand resource constraints and identify and lead cost saving opportunities.
• Might be accountable for a minor budget -Ensure compliance to Novartis and other relevant regulations.
• Writing and reviewing of SOPs.
• As process owner being accountable for process improvement.
• Drive implementation and sustain phase within area of expertise -Consolidate data evaluation, propose solutions and contribute to risk mitigation plans -Act as role model for cultural evolution within TRD -Being accountable for process improvement as leader or member.
• Drive implementation and sustain phase in and outside expertise / organization.
• Support cultural evolution within own function by showing positive work ethics and influencing others.
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

Key performance indicators:

• Adherence to costs, 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 KPIs (if applicable)

Minimum Requirements:

Work Experience:

• Functional Breadth.
• Managing Crises.
• People Challenges.
• Collaborating across boundaries.
• Operations Management and Execution.
• Project Management.

• 10 years relevant experience.

  
  

Skills:

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

Languages:

• English.

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Division

Development

Business Unit

Universal Hierarchy Node

Location

India

Site

Hyderabad (Office)

Company / Legal Entity

IN10 (FCRS = IN010) Novartis Healthcare Private Limited

Functional Area

Research & Development

Job Type

Full time

Employment Type

Regular

Shift Work

No

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