QA Manager ESO SM

328454BR
Oct 05, 2021
Spain

Job Description

70+ billion! That’s the number of units Novartis Technical Operations (NTO) supplied to over 150 countries in 2019. Our 26,000+ associates from 100 different countries are working hard to build an inspired, curious and unbossed culture in which everyone is enabled to be their best. We are unleashing the power of our people and putting data and digital at the heart of our transformation that is enabling us to reach more patients, on time, across the world.
Efficient and collaborative partnering and management of third party operations is of critical importance for continued Novartis’ success. Do you want to be part of the team?

Your responsibilities include, but not limited to:

- Lead External Suppliers Qualification process.
- Acts as Single Point of Contact / SPOC for all quality related activities at the External Supplier.
- Ensure that all aspects of the handling, manufacturing and distribution of biopharmaceutical / pharmaceutical products are in compliance with the Novartis Pharma Quality Manual, the effective Quality Agreement that they meet relevant cGMP regulatory requirements and are conducted according to local SOPs.
- Responsible for driving / initiating External Supplier Quality Risk assessments to be carried out for all External Suppliers. Gaps are Quality Systems to be identified with an evaluation of the associated risks. Remediation plans are to be defined and execution is to be monitored to ensure that issues are suitably addressed.
- Provide the quality presence and input to technical meetings with the external suppliers and establish good working relationships with clear communication and defined actions and goals.
- Ensure that a valid QA agreement defined in line with the requirements of the Global template is in place which clearly defines cGMP roles and responsibilities between Novartis and the External Supplier, as well as product details and requirements.
- Request, review and process GMP documentation as defined by the Quality Agreement and Novartis SOPs. Manage the quality aspects of the relationship in accordance with the effective Quality Agreement. Perform the required periodic review and make recommendations for amendments to the agreement based on identified needs and issues.
- Responsible for coordinating and ensuring that Quality auditing of external suppliers is carried out according to the Novartis Quality Manual - maintain an annual auditing program, participate in and/or lead audits, manage action plans and follow up on agreed upon CAPAs. Ensure site readiness for regulatory inspections at External suppliers where appropriate.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Minimum Requirements

What you’ll bring to the role

- Strong experience in quality management, quality control, manufacturing, regulatory affairs, or other related discipline.
- Strong communications skills dealing with senior stakeholders.
- University degree in pharmaceutical, chemical or other appropriate natural sciences.
- Fluency in English.
- Strong knowledge of Microsoft Office.

You’ll receive: Company Pension Plan; Life and Accidental Insurance; Meals Allowance or Canteen in the office; Flexible working hours

Why consider Novartis?
799 million. That’s how many lives our products touched in 2019. 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!

Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Novartis Technical Operations
NTO QUALITY
Spain
Barcelona
Quality
Full Time
Regular
No
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328454BR

QA Manager ESO SM

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