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Job Details


Novartis

Global Compliance Lead, GMP (REMOTE) (338223BR)

Pharmaceuticals

All

Yearly

No

East Hanover, New Jersey, United States

Job Description

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!

Reporting to the Global Head of Compliance and interacting across Novartis Technical Operations, the Global Compliance Lead, GMP will serve as the single point of contact for GMP compliance within the Global QA Compliance organization. This position is accountable for the development and implementation of global processes, procedures and systems aligned to the Novartis Global GMP compliance strategy and ensuring governance and oversight of key compliance metrics across the platforms. The Global Compliance Lead ensures that NTO complies with worldwide regulatory requirements, readiness of sites to host successful Health Authority Inspections/audits, and predicts compliance risk to avoid reputational risk. The incumbent will coordinate and work alongside Compliance Platform Leaders and other associates accountable for implementing the GMP compliance strategy worldwide, providing oversight and guidance to compliance upgrade projects and ensures remediation activities are undertaken and implemented at all affected sites and functions, while verifying effectiveness.

Major Accountabilities:

• Provide Quality governance and GMP compliance oversight for strategic Novartis Technical Operations sites to minimize related risks, assure product availability to patients, and maximize the success of site regulatory inspections.
Address any potential signals as necessary to assure effectiveness.

• Enforce LLN process and approach to share and implement best practices across the Novartis Technical Operations network.

• Facilitate the GMP compliance alert process across of the Novartis Technical Operations network and reporting on status.

• Provide effective support during Regulatory Inspections as requested by Novartis Technical Operations Quality and sites. Support sites with inspection readiness be-fore and during strategic Health Authority Inspections, audits, compliance upgrade projects, and assures remediation activities are undertaken, implemented, and the effectiveness verified at the affected sites.

• Develop compliance strategies and provide oversight governance & direction to the members involved in QA oversight.

• Contribute to DI culture change across Novartis Technical Operations network, particularly with human behaviors and culture elements.

• Assist with the development and deployment of strategic Quality/Compliance related projects.

• Investigation support for situations involving potential GMP gaps/failures that result in material impact to Novartis Technical Operations, as requested. Working collaboratively and cross-functionally with Corporate Security, Business Practices Office, Legal, and other Novartis functions as necessary.
• Proactively analyzes Novartis Technical Operations data for risks, signals and trends associated with GMP and other serious issues. As necessary, works collaboratively with the responsible business units to develop and implement resultant CAPAs.
• Assist sites in ensuring that Novartis Technical Operations facilities achieve, maintain and constantly improve the required level of quality and compliance by identifying deficiencies and providing independent advice, recommendations and solutions.
• Support the Quality Systems Program and other internal compliance initiatives.
• Participate/Lead Health Authority communications as deemed necessary and appropriate by the Global Head QA Compliance.
• Represent Compliance function/strategy on cross-functional teams

Key Performance Indicators:

• Coordinate to address any potential signals, as necessary to avoid Compliance Risks, by providing Quality governance and GMP compliance oversight.

• Strengthen QA GxP Compliance process across the organization.

• Assist with the development and deployment of strategic Quality/Compliance related projects and effectively strengthen the collaboration with the platforms and the sup-port to the sites.

• Successfully enforce LLN and best practices across the Novartis Technical Operations sites, including GMP Compliance alert process.

• Facilitate the GMP compliance alert process across of the Novartis Technical Operations network

• Contribute to DI culture change across Novartis Technical Operations network, particularly with human behaviors and culture elements.

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