Summary
About the Role
Major accountabilities:
Operational
- Collaboration in GxP audits/inspections
- 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
- Support the QA operation team and product release during project phase
- Responsible for deviation handling
- Responsible for Change Control management
- Responsible for system improving
Leadership & Culture
- Drives the talent agenda: Leads people processes through recruitment, training, coaching and performance to meet all operation requirements and supports a robust career path deployment and succession plan for area of responsibility
- Invest time in personally developing and coaching talents
- Actively support and promote talent exchange for the benefit of the individuals and organization
- Ensure the consistency between career development processes and the business strategy
- Support the T&L organization by identifying and reviewing the appropriate list of training for all in-scope associates
- Ensure that associates are qualified for a GMP task prior to independent performance
- Monitor overall training compliance for in-scope associates
- Identify and maintain a list of subject matter experts for in-scope areas of expertise
- Create a work environment that enables high employee engagement
- Role model the culture aspiration of being Curious, Inspired and Un-bossed and ensure leaders and associates are aware and aligned on expectations and hold them accountable for success of culture journey
HSE
- Promote and improve the Safety and Quality cultures, by implementing the necessary systems and actions in line with the evolution of the site
- Ensure overall inspection readiness for area of responsibility.
- Guarantee the effectiveness of the Business Continuity Plan within area of responsibility
- Responsible for participating in initial training and retraining
- HSE incidents reporting & action follow-up
Key Performance Indicators
- Successful oversight and implementation of Quality Management System
- Carry out improvements in GMP compliance
- Exception and Incident management
Relevant Experience
- Several years of experience (> 3 years) in the field of GMP production or QA or QC Professional experience from official and / or customer audits Expertise in GMP (sterile/non-sterile)
- Functional Breadth; People Leadership; Organization Scope; Scale and Complexity; Collaborating across boundaries; Project Management
Education & Qualification
- University degree with a scientific / technological background (e.g. Chemistry, Pharmacy, Biology, Biochemistry, or equivalent)
Languages
Fluent (oral and written) in English; good in local language (oral and written)
Competencies
- Collaboration; result-oriented; problem-solving-oriented
- Advanced communication skills; motivates colleagues and co-workers
- Maintains exchange of experience
- Leadership and change management, objective setting and performance management
- Budget management, Operational Excellence, Risk Management
- Project Excellence; Stakeholder Engagement; Organizational Savvy; Applied Business Insights
- Additional qualification in the GMP area
- Quality Assurance; Knowledge of GxP, Health Authorities, Supplier Relationship Management; Strategic thinking and planning; Quality decision making; Interdepartmental collaboration; Communication skills; Problem-solving-oriented; Goal-oriented
- MS Office applications and other standard IT applications supporting Quality activities
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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Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.