338223BR
May 16, 2022
USA

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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Diversity & Inclusion / EEO

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. 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.

Minimum Requirements

What you'll bring to the role:

This role can be based anywhere in the US.

•Education: Undergraduate Degree in a science discipline; additional knowledge in Pharmaceutical Manufacturing technology and practices; Quality Assurance/Compliance and Auditing; graduate degree desired
•Languages: English, must be fluent in speaking and writing; 2nd language desired

Experience: Minimum of 15 years experience in the pharmaceutical or biopharmaceutical industry in the area of compliance and investigations. Direct experience working for a regulatory body (e.g. MHRA or US FDA) is desired. Demonstrated ability to effectively execute detailed and complex investigations, including detection of potential data integrity breaches, fraud, misconduct, etc. Experience cooperating with government agencies and law enforcement through the investigation process is desirable.
• Prior inspection / auditing experience required (min. 3 years)
• Strong oral and written communication, social and organizational skills required
• Availability for min. 35 % travel on a global basis


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

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 QUALITY
USA
East Hanover, NJ
Quality
Full Time
Regular
No
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338223BR

Global Compliance Lead, GMP (REMOTE)

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