MS&T Processes and Standards Lead

328034BR
Sep 21, 2021
India

Job Description

28,000 associates of more than 100 nationalities deliver high-quality and affordable medicine on time, every time, safely and efficiently.

Your key responsibilities:
Your responsibilities include, but not limited to:

• Responsible for establishing and maintaining the MS&T global standards for key Business Processes/Quality Systems (e.g. product improvement portfolio, manufacturing robustness review board). Provide guidance and oversight to manufacturing sites.
• Interface to Quality Systems & Standards and Novartis Group Quality Systems and Standards Council (QSSC) to ensure the business requirements and expectations are maintained within the standards.
• Responsible for transforming MS&T relevant business processes from reactively managed to proactively defined and from quantitatively managed to continuously optimize. Maintain knowledge of and influence current industry trends and Health Authority expectations to influence internal standards accordingly to incorporate and translate into business processes.
• Collaborate with quality function to ensure alignment with QA and product stewardship, drive the implementation of Internal Release Limits and ensure alignment in the product improvement agenda with respect to test method improvement.
• Responsible for alignment of MS&T Systems and Standards through direct interface with Business Units representatives. Proactively review the Quality Systems to identify MS&T trends across the organization and to ensure alignment with industry expectations.
• Ensure alignment with Novartis Quality System (QMs/QDs/ SOPs). Review and provide feedback of all relevant Quality Modules and Directives. Provide input into the alignment and update of global standards.
• Evaluate, develop and support the implementation of the ‘product improvement portfolio’ and ‘manufacturing robustness review board’ for use across the platforms.

Minimum Requirements

What you’ll bring to the role:

• Minimum of 12 years of experience in Technical Development, Pharmaceutical, Chemical, or Bio-logical Operations.
• Broad experience in Technical Development, QA/QC line functions, and/or manufacturing departments.
• Extensive experience in global and local MS&T, QA and QC business processes, standards, regulatory requirements and project management, IT systems and operational excellence.
• Demonstrated matrix leadership skills through global project teams and/or departments.
• Knowledge of external and internal quality standards and industry best practices, preferable.

Desirable: University degree in Pharmacy, Chemistry, Engineering or equivalent discipline; additional knowledge of Quality Systems and Business Process Management

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 the 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!


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
Novartis Technical Operations
NTO STRATEGY & OPERATIONS
India
Hyderabad, AP
Technical Operations
Full Time
Regular
No
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328034BR

MS&T Processes and Standards Lead

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