Summary
About the Role
Major accountabilities:
- Oversight and implementation of Quality Management System -Incident management.
- GxP Audit and inspection management -Site Regulatory oversight (incl. Reg-CMC facilitation) -Exception management -Supplier Quality management (local) -Qualification and validation -Quality Compliance -Data Integrity and eCompliance -Site KPI / KQI maintenance / reporting -Initiate and drive local hiring process -Line responsibility and daily walkthrough -Lead OpEx Projects -Investigation of Deviation, OOx, Complaints -Define and implement CAPAs -Support transfer projects and validation studies -Track team metrics and ensure KQI/KPI meet requirements -Review and approve text and design -HSE incidents reporting and action follow-up -New equipment commissioning support (OQ, PQ) -Define improvement areas in process and products -Resource and capacity (people and equipment) planning and workload management -Performance and leadership support to specialist team -Ensure availability of equipment, chemicals and consumables, as appropriate -SOP review and revision -Perform local training and monitor training status -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 and delivery dates, passing of internal and external inspections.
- Meet quality and timelines for all projects.
- Act in accordance with Novartis standards.
- The number and severity of cGMP issues identified during internal and external audits -Year-end figures within budget.
- Successful coordination of departmental operational activities
Minimum Requirements:
Work Experience:
- Functional Breadth.
- People Leadership.
- Project Management.
- Collaborating across boundaries.
- Critical Negotiations.
- Operations Management and Execution.
Skills:
- Agility.
- Auditing.
- Business Acumen.
- Business Partnering.
- Collaboration / Teamwork.
- Communication Skills.
- Compliance Audits.
- Continuous Learning.
- Dealing With Ambiguity.
- Decision Making Skills.
- Employee Performance Evaluations.
- Finance Acumen.
- Gmp Procedures.
- Goal Oriented.
- Health Authorities.
- Leadership.
- Logical Thinking.
- Major Incident Management.
- People Management.
- Problem Solving Skill.
- Problem Solving Skills.
- Qa (Quality Assurance).
- Self Awareness.
- Smart Risk Taking.
- Stakeholder Management.
- Technological Expertise.
- Audit Management.
- Inspection Readiness.
- Product release.
- Organizational skills.
Languages :
- English.
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
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Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
