Site Quality Head

Summary

• Provide Leadership and manage Quality Assurance Managers in all quality related matters and to ensure that all aspects of the operational business comply with cGMP (Current Good manufacturing Practices) legal and regulatory requirements and the Novartis Quality Manual and Policies.
• Ensure that all products manufactured by site/External Supplier in addition to the imported products for local site are released to the market according to Novartis Quality Standards.

About The Role Major Accountabilities:

• Critical Negotiations, People Leadership, Operations Management and Execution, Collaborating across boundaries, Project Management
• 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

• Successful support of projects with agreed quality & delivery dates, passing of internal and external inspections.
• Meet quality & timelines for all projects.
• Act in accordance with GMP, ethical, health safety and environment (HSE), and information security (ISEC).
• The number and severity of cGMP issues identified during internal and external audits.
• Year-end figures within budget.

Background (State The Preferred Education And Experience Level) Education & Qualification University degree in Pharmacy, Engineering, Chemistry, Biotechnology or

equivalent.

Language Fluent (oral and written) in English; local language desired

Relevant Experience

• Minimum: 12-15 years’ experience in the field of Quality Assurance and Quality Control in a pharmaceutical industry environment or equivalent
• Operations Management and Execution, People Leadership, Collaborating across boundaries, Functional Breadth, Project Management, Financial Management, Industry/ Business Exposure

Competencies

• Collaboration; result-oriented
• Advanced communication skills; motivates colleagues and co-workers
• Leadership and change management, objective setting and performance management
• Being Resilient; Stakeholder Engagement; Operational Excellence; Applied Business Insights
• Budget management; Risk Management
• Product Release; Audit Management; Health Authorities; Technical Launch and Transfer
• Knowledge of GMP Quality Control (QC) Testing, Manufacturing Process/Product Expertise
• Expertise in GxP operations.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.

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