Functional lead for the Diagnostics Emeryville site to ensure that all aspects of the opera-tional business comply with cGMP regulatory requirements, and the Novartis Vaccines and Diagnostics Quality Manual. Reports on the status and completion of the Emeryville site responses and commitments from audits (internal and external), tracks trends and monitors the effectiveness of actions taken. Assists in the development, implementation, and continuous improvement of the compliance profile of the Emeryville quality system.
• Responsible for managing all regulatory Health Authority inspections, responses and follow-up actions.
• Responsible for managing all Novartis division and customer audits, responses, and follow-up actions.
• Responsible for the Emeryville self-inspection program including the procedures, audit schedules, audit reports, and observation follow-up and closure.
• Responsible for the Emeryville Diagnostics Supplier Quality program including procedures, audit schedules, Quality Agreements, quality questionnaires, audit reports, follow-up and closure.
• Locally support and supervise GMP upgrade projects and ensure compliance with global standards.
• Support business unit and ensure readiness for regulatory inspections.
• Lead and/or support global quality programs in Diagnostics.
• Develop overall Quality programs in alignment with business objectives.
• Manages understanding and accountability of staff in re-mediating regulatory quality compliance deficiencies.
• Maintains operational metrics related to Compliance programs.
• Provides guidance and interpretation of regulatory regulations as they apply to Em-eryville Diagnostics.
• Bachelors or Masters Degree (preferable), in life or physical sciences, with experience in a clinical laboratory, diagnostic quality or technical area.
• Ten (10) years of experience in quality and/or pharmaceutical manufacturing.
• Knowledge of regulations and standards affecting IVDs and Biologics.
• Experience with project management (problem solving and resolution) and general business principles.
• Understands the global implication of failure investigation.
• Training in leading audits and experience as lead auditor or interacting with Health Authorities and/or CQA/CQA Biomedical a plus.
• Excellent people management and communication skills as well as strategic and conceptual thinking.
• Advanced computer skills to visually ease data communication and conclusions, such as Excel, Visio.
Novartis AG, incorporated on February 29, 1996, is a Switzerland-based holding that, through its subsidiaries, is engaged in the research,...