Oct 25, 2021

Job Description

Quality Project Lead Medical Devices (f/m/d), Schaftenau, Austria

80 products in the pipeline, innovation concepts and increasing impact on the overall NVS technical development portfolio! As part of our QA Team, you will support us in actively mastering this challenge every day with the latest technologies and thus achieving the goal of making high-quality products available to patients all over the world.

We are convinced: curious, ambitious and team-oriented people like you will find new answers together in an inspiring environment and make courageous decisions.

Your key responsibilities:

Your responsibilities include, but are not limited to:
• Provide QA expertise and guidance to ensure compliance with requirement of the quality system are met, including implementation of quality risk-based and GxP-relevant process.
• Lead and manage QA Project Management activities and collaborate with business partners and other quality groups to ensure health authority and regulatory requirements are fully met.
• Translate functional QA strategy into applicable operational/compliance activities and support a risk-based implementation and execution of processes.
• Ensure quality and compliance gaps are addressed and executed for sustainability and implement strategic process improvement, including review of procedural updates, training, process improvement, effectiveness checks, etc.
• Monitor implementation of the Quality Plan and support inspection readiness activities, including participation in regulatory inspection preparation, management and follow-up.
• Support quality oversight/management of external service providers and IT systems supporting research and development activities and drive facilitation and follow-up of audits and inspections, and ensure development, implementation and completion of appropriate corrective and preventive measures for findings.
• Ensure timely escalation of deviation/incidents and provide quality oversight for deviations/incidents, including robust investigations, root cause analysis and corrective actions implementation.
• Contribute towards lessons learned based on audits, inspections, incidents, regulatory intelligence, effectiveness checks on process implementations and metrics and support a culture of proactive, risk-based behaviour

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

What you’ll bring to the role:
Experiences working with Health Authorities
Influencing and persuading skills
Knowledge of TQM and related industry GxP standards and processes
Quality Management
Regulations & Guidelines
Risk Management
Vendor Management

Desirable requirements:
• Full proficiency in English, fluency in German is an advantage

Why Novartis?

769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

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 thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!

In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development options as well as worldwide career opportunities within the Novartis group. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is € 63.388/year (on a full time basis). The actual salary will be significantly higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.
We are open for part-time and job sharing models and support flexible and remote working where possible.

Commitment to Diversity & Inclusion:
Our recruitment decisions are based on selecting the best person for the job, regardless of gender, religion, age, colour, race, sexual orientation, nationality or disability.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Global Drug Development
Full Time
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Quality Project Lead Medical Devices (f/m/d)

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