Site Quality Head Strategic

1 mese fa

Torre Annunziata, Italia Healthcare Businesswomen’s Association A tempo pieno

Job Description Summary

We are seeking a Site Quality Head who will inspire and empower the team to reach new heights of success for a well-established manufacturing site for Solid dosage forms in Torre Annunziata. By nurturing talent and fostering a positive work environment, you can unlock your team's full potential.

To ensure the delivery of top-notch products and services, the maintenance and development of robust quality assurance processes and quality control systems are paramount. By adhering to legislation, internal regulations, and industry best practices, you can instill trust in your customers and stakeholders. These processes act as a safety net, guaranteeing that every release activity meets the highest standards of quality and reliability.

This role will work directly with the Global Quality Platform team and will report to the Global Quality Platform Head.

Major accountabilities:

  • Leadership of Site Quality organization and Quality oversight of GxP site functions.
  • Acts as site Technical Responsible Person (Qualified Person), as appropriate.
  • Ensures that Site quality risk assessments are in place, DI and eCompliance standards applied. Ensure compliance with all cGxP and all regulatory requirements for manufacturing, control and distribution operations.
  • Drives the talent agenda: leads people processes through recruitment, training, coaching and performance to meet all operation requirements sustaining both site and quality unit competitiveness and diversity.
  • Ensure that associates are qualified for a GMP task prior to independent performance.
  • Role model the culture aspiration of being Curious, Inspired and Unbossed and ensure leaders and associates are aware and aligned on expectations and hold them accountable for success of culture journey.
  • Ensure overall inspection readiness for area of responsibility.
  • Being part of the site crisis management team and depending on skills, expertise and experience can be appointed to one of the NEM roles (Novartis Emergency Management).
  • By delegation of the Site Manager may be required to take decisions and take the necessary actions, in particular within the framework of the on-call management system.

Minimum Requirements:

  • Education: Bachelor Degree in Chemical Engineering / Chemistry / Pharmacy or another natural science.
  • 10+ years of experience in the pharmaceutical industry (Quality Assurance, Quality Control, Regulatory and/or Production).
  • Fluent English written and spoken, other languages are a plus.
  • Ability to function within ambiguity and cross-functional collaboration.
  • In-depth manufacturing processing knowledge / experience and Quality Compliance knowledge.
  • Proven performance in Health Authority inspections.
  • Fluent English and Italian, written and spoken.

We offer permanent employment, with 6 months of probation period.

Why consider Novartis?

769 million. That’s how many lives our products touched in 2020. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

Imagine what you could do at Novartis

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