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Novartis Pharmaceuticals Country Quality Head in Petaling Jaya, Malaysia

310442BR

Job ID:

310442BR

Job Description:

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?

As Country Quality Head, you will be key partner to senior stakeholders the business in commercial and clinical functions, providing Quality oversight and governance to ensure proactive compliance with Novartis and Health Authority GxP requirements, and to meet business expectations.

Your Responsibilities:

Your responsibilities include, but not limited to:

• Lead QA function ensuring that all processes and procedures, tasks, responsibilities and projects are in compliance with all pharmaceutical laws, the Novartis Quality Manual and Policies as well as Industry Best Practices.

• Ensure that all quality relevant processes are compliant and that non-compliance is appropriately addressed via corrective & preventive actions (CAPA) and/or escalation of issues

• Ensures adherence to GxP, any further legal and company internal regulations for manufacturing, control and distribution operations and to HSE guidelines and requirements

• Implement defined Key Quality Indicators in the area of responsibility to monitor on an on-going basis that relevant processes are in control and compliant. Regularly review and assess KQIs at the Leadership Team level.

• Ensure communication with local Health Authorities is shared within the organization and commitments tracked and closed on time.

• Ensure that processes are in place to communicate country specific requirements to the Region and headquarter organizations for all GXP areas and assess their implications for the compliance of existing processes and systems. Initiate remediation activities, as necessary, to ensure ongoing compliance.

• Process complaints and establish an efficient recall organization

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Position Title:

Country Quality Head

Minimum requirements:

What you’ll bring to the role:

• Bachelor’s Degree or equivalent University degree in a Scientific or Technology field (e.g. Chemistry, Pharmacy or other Life Science). Advanced Degree preferred

• More than 12 years experience in Pharmaceutical Industry across Quality Commercial / Quality Operations / Development, with minimum 8 years’ experience in management role

• Expert understanding of GxP regulations from major Health Authorities

• Strong skills in planning, develop, implement and evaluate marketing strategies for on-going and new products.

• Possess strong analytical, communication strategies and leadership collaborative skills

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

Job Type:

Full Time

Country:

Malaysia

Work Location:

Petaling Jaya

Functional Area:

Quality

Division:

Novartis Technical Operations

Business Unit:

NTO QUALITY

Employment Type:

Regular

Company/Legal Entity:

NOV MALAYSIA

Shift Work:

No

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