Eso Qms Manager

hace 2 semanas


Barcelona, España Novartis A tiempo completo

365 days a year, our global manufacturing and supply network works to ensure our patients have the treatments they need to live longer, healthier lives.
ESO QMS Manager ensures implementation, maintenance and continuous improvement of Global ESO QMS processes, procedures and respective tools to drive standardisation and harmonization and meet applicable Novartis internal requirements and external regulations. The ESO QMS Manager also ensures to have QA governance and oversight on document and record management activities in ESO organization and maintains knowledge with current industry trends, Health Authority expectations.

**This is a temporary position for maternity leave**

**Major Accountabilities**
- Supports the development, implementation, and continuous improvement of NTO ESO QA processes, procedures and standards to ensure compliance with cGMP/ICH, Regulatory Authority, Novartis Quality Modules and Directives related to Supplier management. Support the Development of ESO Quality management systems.
- Document Management: ESO procedures governance, SOP Manager, SOP Master List, simplification initiatives, Subject Matter Expert and Single Point of Contact for standard Document Management Systems such as ESOPS D2 or CONDOR
- Responsible for all necessary records regarding the Global Standard implementation as well as supporting the ESO document authors to implement the requirements described in the Global Standards.
- Establish strong partnership with key stakeholders.
- Act as a QMS representative and liaison partner in other initiatives, boards, meetings as necessary.
- Maintain knowledge of current industry trends and Health Authority expectations.

**Commitment to Diversity & Inclusion**:

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

**Minimum requirements**

**Obligatory requirements**:

- Thorough knowledge of cGMP.
- At least 5 years’ experience in pharmaceutical industrial Quality

and Compliance related activities or strong proved background and knowledge in GMP operations (e.g. Manufacturing and Science).
- Strong analytical skills and understanding of risk management fundamentals / tools.
- Background in Quality and Supply Management is a must.
- English written, spoken and read.
- Good organizational, intercultural communication, and interpersonal skills.
- Definitive and authoritative decision-making ability, team and consensus builder and, negotiation skills.

**Desirable requirements**:

- Supplier management oversight background.
- Quality Risk Management experience
- Experience working in a global matrix organization preferred.

**You’ll receive**:
Competitive salary, annual bonus, pension scheme, health insurance, flexible working arrangements, subsidized dining facilities, employee recognition scheme.

**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**

**Division**

Operations

**Business Unit**

QUALITY

**Country**

Spain

**Work Location**

Barcelona Gran Vía

**Company/Legal Entity**

Novartis Farmacéutica, S.A.

**Functional Area**

Quality

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

No


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