Senior Quality Manager - TRD QA

Quality Assurance Expert Responsibilities

Located in Basel, Switzerland, the primary focus of this role is to deliver expertise and support in quality assurance to operational activities within development and research organizations. The aim is to ensure adherence to relevant regulatory requirements as well as Novartis procedures and quality standards.

Key Responsibilities

• Support the maintenance of regulatory-required files for health authority inspections and assist in managing health authority inspections.
• Assist in the generation and review of Quality Plans for clinical programs, ensuring comprehensive quality and safety aspects are considered.
• Contribute to initiatives aimed at enhancing quality performance and compliance through risk management and health authority reporting.
• Identify opportunities for quality, process, and compliance improvement, and develop strategies to enhance quality while meeting regulatory obligations.
• Evaluate data from quality initiatives, audits, and assessments to pinpoint training needs related to regulatory compliance and quality assurance.
• Help identify quality issues, conduct root cause investigations, and support the formulation of corrective and preventive action plans (CAPA), monitoring their implementation.
• Assist in the remediation of deviations, ensuring thorough follow-up and tracking of corrective actions.
• Manage quality aspects of projects and activities, reviewing and approving quality deliverables to verify compliance, including contractor work and clinical trial materials.
• Report technical complaints and adverse events related to Novartis products within 24 hours of notification.
• Facilitate the distribution of marketing samples as applicable.

Qualifications

Experience

• Demonstrated functional breadth in critical negotiations and project management.
• Experience collaborating across different organizational boundaries.

Skills

• Understanding of CAPA, Quality Assurance, and Quality Management fundamentals.
• Proficient knowledge in Risk Management and Root Cause Analysis (RCA).
• Strong self-awareness and Six Sigma methodology knowledge.
• Familiarity with Standard Operating Procedures (SOPs) and technological expertise relevant to quality assurance.

Language Proficiency

• Fluency in English is essential.

Work Environment

Our commitment extends to creating an inclusive workplace and diverse teams that reflect the communities we serve. Novartis believes that innovative science and a supportive community are essential for helping individuals with diseases and their families.

Why Choose Novartis?

At Novartis, we bring together a community of passionate professionals who collaborate, support, and inspire one another to achieve breakthroughs that can change patients' lives. Are you ready to join us in creating a brighter future?

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