Summary

Provide strategic and technical leadership for the site in all quality and cGMP compliance related matters and ensures that all aspects of the operational business comply with cGMP legal and regulatory requirements and Novartis Quality Manual requirements.

About the Role

Major accountabilities:

• Leadership of Site Quality organization
• Implement, comply with, and govern practices prescribed in the Novartis Manufacturing Manual -Quality oversight of GxP site functions .Acts as site 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 Site Master File for regulatory purposes
• Site 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 site .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

• No critical observations during authority inspections - No delay with new product introductions caused by the unit - Timely closing of deviations/complaints

• Industry/ Business Exposure.
• Functional Breadth.
• Financial Management.
• Project Management.
• Collaborating across boundaries.
• People Leadership.
• Operations Management and Execution.

• Agility.
• Audit Management.
• Business Acumen.
• Business Partnering.
• Business Strategy.
• Continuous Learning.
• Dealing With Ambiguity.
• Employee Performance Evaluations.
• Finance Acumen.
• Health Authorities.
• Knowledge Of Gmp.
• Leadership.
• Manufacturing (Production).
• People Management.
• Product Release.
• Qa (Quality Assurance).
• Quality Control.
• Quality Management.
• Quality Management Systems (Qms).
• Root Cause Analysis (Rca).
• Self Awareness.
• Six Sigma.
• Smart Risk Taking.
• Stakeholder Management.
• Storytelling.
• Technological Expertise.
• Technology Transfer.
• Organizational Savvy.

• English.