SUMMARY

The QA Compliance Expert ensures compliance and drives continuous improvement of quality systems related to Data Integrity (DI) and contractor management. This role supports the implementation of efficient, sustainable processes that meet regulatory expectations across the global Novartis product portfolio.

KEY ACCOUNTABILITIES

• Act as site subject matter expert (SME) for all Data Integrity (DI) inquiries and DI training.
• Establish and maintain a network of DI SMEs/Champions across GMP functions (e.g. Manufacturing, QC, Automation).
• Collaborate with DI SMEs/Champions to promote behavioral change and strengthen DI culture; provide quality and compliance oversight for material suppliers supporting other NPMG sites
• Identify DI training needs, develop relevant materials, and facilitate training delivery.
• Provide site support for DI-related investigations, escalations, reviews, and audits (internal and external); serve as SME for DI and contractor/supplier management during audits/inspections
• Lead and monitor execution of the site DI Plan, including communication and engagement activities; report progress to site leadership.
• Manage contractor qualification and oversight (quality agreements, audits, risk assessments, surveillance planning).
• Align with contractor managers across the campus to ensure consistency and best practices; support implementation of global processes related to DI and contractor/supplier management

ESSENTIAL REQUIREMENTS:

• At least 3 years or more experience in QA
• Work experience in a GMP regulated environment in the pharmaceutical industry
• Good communication skills, Experienced problem solving
• Continued learning (dynamic knowledge development)
• Takes over responsibility and delivers reliably
• Teamwork: Good Cooperation with different Departments and Functions
• Fluent knowledge of English language (written and spoken)