Summary
-Leads the team for Quality in the site and works in strong collaboration with other members of the site leadership team.
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 regulation
- 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 fulfilment 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
- Ensuring personal and people development
- Lead and develop QA team and develop for successful workforce planning and future success skills
- 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:
- No critical observations during authority inspections.
- No delay with new product introductions caused by the unit.
- Timely closing of deviations/complaints.
Minimum Requirements:
Work Experience:
- Audit & Inspection Management.
- Good Manufacturing Practices (cGMP).
- Product Quality (PQ).
- Release Management.
- Contract Manufacturing.
- Supplier Relationship Management (Srm).
- Technical Operations.
- GxP Experience.
- People Management.
- Quality Assurance.
- Quality Compliance.
- Quality Management Systems.
- Quality Control.
Skills:
- Analytical thinking.
- Business Acumen.
- Business Strategy.
- Finance Acumen.
- Leadership.
- Risk Management.
- Smart Risk Taking.
- Stakeholder Management.
- Strategic Planning.
- Strategic Thinking.
- Organizational Saviness.
- Industry standards Knowledge
- Storytelling.
- Collaboration.
- Communication skills.
- Data Integrity.
- Digital saviness.
- Decision Making.
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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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.
