Quality Head Sandoz Italy

2 settimane fa

Milano, Italia Novartis Argentina A tempo pieno

Job ID- 366954BR- Mar 27, 2023- Italy**Job Description**:

- 2023 will see Sandoz become a standalone organization As a global market leader in Generics and Biosimilar medicine, Sandoz is stepping forward from a position of strength Those joining Sandoz in the coming months will help shape the future of the company, it’s growth, innovation, culture and how Sandoz impacts the lives of millions. These will be careers with genuine impact This is one such role**Are you ready to make a difference?**

**Role Purpose**

The quality manager actively participates in the design, implementation, monitoring and maintenance of an effective pharmaceutical quality system and to proactively ensure compliance with relevant GxP regulations and Sandoz quality standards.
- Supports business growth, promote continuous improvement and promote standardization and increased efficiency through innovation projects and operational excellence.
- Lead with high integrity and build a diverse, effective and agile quality organization by bringing our new Sandoz values and behaviors to life.**Your Key Responsibilities**

Your responsibilities include, but are not limited to:
- Successfully lead the Quality team, attract, develop and retain talent in the organization supporting a diverse and inclusive culture. Ensure robust performance management to optimize productivity across the organization. Provide active mentoring and coaching of associates. Lead the implementation and execution of the talent management strategy for all key positions in conjunction with regional colleague(s). Inspire people with integrity and through role modelling and cultural behaviors to enable to quality organization to transform and perform;
- Lead a quality culture with high awareness on data integrity and close collaboration with country business partners and ensure a state-of-the-art country quality organization is in place to best support overall business strategy
- Ensure timely delivery of all quality services and ensure all aspects of team activities comply with GxP, legal and regulatory requirements and the Sandoz corporate quality manuals and policies; Deliver successful GxP regulatory inspections and internal audits of the country organization
- Establish effective quality oversight and ensure quality plan is implemented in the country organization; Ensure a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management;
- Act as a company key point of contact for Health Authority field alert and drug shortages providing a link between supplying sites and the Health Authorities; continuously engage in benchmarking with other industries, industry peers and actively engage across countries in building proactive relationships with Health Authorities
- Ensure that the applicable Medical Device legislative requirements are implemented and maintained within the quality management system and that the Medical Devices are distributed in compliance with FAMHP “Guidance for Distributors of Medical Devices”;
- Ensure a formal process is in place for reviewing the pharmaceutical quality system periodically and conduct regular review and assessment of process performance and product quality, actively involving senior management;
- Lead the implementation of applicable quality standards and effective CAPA processes and ensure compliance with escalation processes in the country organization;
- Ensure that relevant SOPs are aligned to HA regulatory requirements;

**Diversity & Inclusion / EEO**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum Requirements**:

- Bachelor’s Degree or equivalent 4-Year University degree in a Scientific or Technology field (e.g. Chemistry, Pharmacy or other Life Science). Advanced degree preferred.
- Fluency in English and Italian. Additional Language is a plus
- 12 years of experience in Pharmaceutical Industry across Quality Commercial/Quality Operations/Manufacturing/Development.
- Expert understanding of GxP regulations from major Health Authorities
- Experience in the development and implementation of Quality Management Systems incl. Compliance & Auditing and dealing with Health Authorities
- Previous experience in Regulatory submissions and registration
- Prior experience in Product Lifecycle and product portfolio management

**Why Sandoz?**

500 million patients were touched by Sandoz generic and biosimilar medicines in 2021 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world
How will we do this? We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working
We believe our potential can thriv

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