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Quality Compliance Manager

Novartis Vaccines & Diagnostics, Inc.

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Location: Emeryville, CA Posted Date: 4/25/2013 Position Type: Full time Job Code: 3641824HHL Salary: Competitive Required Education: Bachelors Degree Areas of Expertise Desired: Allied Health

Description


The incumbent will be responsible for leading the Self Inspection program for the Diagnostics Emeryville site to ensure compliance with ISO standards, cGxP regulatory requirements and the Novartis Vaccines and Diagnostics requirements. Support the Emeryville Diagnostics QA Compliance program, which includes Third Party, Supplier, and Internal/External Inspection management for both local and global functions. * Responsible for the Self Inspection program to ensure a state of business readiness for Health Authority and Novartis Divisional audits. * Perform audits according to Novartis Diagnostics requirements. * Manage CAPA responses, audit reports, follow-up, audit closure, databases and Key Performance Indicators. * Ensure that the Self Inspection schedule is inclusive of all GxP related activities and that the frequency of inspection is consummate with the level of operational risk de-termined for each area and is integrated with existing quality systems e.g. Deviation Management. * Ensure that the Self Inspection program leverages key quality systems, such as Deviation Management, to drive inspection strategy and further operational awareness. * Assist in the approval and monitoring of suppliers and Third Parties for Novartis Diagnostics. Maintains Key Performance indicators and databases. * Support for managing all regulatory Health Authority inspections, responses and fol-low-up actions. * Support Novartis division and customer audits, responses, and follow-up actions. * Support business unit and ensure readiness for regulatory inspections. * Manage understanding in re-mediating regulatory quality compliance deficiencies. * Create and maintain operational metrics related to Compliance programs
Bachelors Degree, in life or physical sciences, with experience in a clinical laboratory, diagnostic quality or technical area. English * 8-10 years of experience in quality and/or pharmaceutical manufacturing. * Training in leading audits and experience as lead auditor or interacting with Health Authorities and/or CQA/CQA Biomedical a plus. * Strong Knowledge of regulations and standards affecting IVDs and Biologics. * Experience with project management (problem solving and resolution) and general business principles. * Experience in trackwise based auditing systems a plus * Knowledge of regulations and standards affecting medical devices, including ISO 13485:2003, EU Medical Device Directives and FDA CFR's * Excellent communication skills as well as strategic and conceptual thinking. * Willingness to travel 5% time. Advanced computer skills to visually ease data communication and conclusions, such as Excel, Visio.

Requirements

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