Quality Control Manager

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POST DATE 9/3/2016
END DATE 12/19/2016

Novartis East Hanover, NJ

East Hanover, NJ
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Full Time
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Job Title :Quality Control Manager

Location : East Hanover , NJ

Duration : 1 YEAR on W2 (EXTENDABLE)

MAJOR ACCOUNTABILITIES : Metrics and Key Quality Indicators - Support the implementation and tracking of compliance to the established clinical trial processes. Responsible to track, report and reinforce adherence to applicable performance measures. Recommend corrective actions based upon report outputs; implement training as applicable to redirect teams to better KQI scores. Track audit and inspection findings, report on results, track trends, generate lessons learned. Drive Risk Mitigation Assessment process to improve the rate of compliance of countries to GMO quality standards. Process Expertise - serves as subject matter expert and input into new SOPs on behalf of GMO, ensure compliance to and adequate training opportunities for new SOPs and Business Guidance. Track deviations from SOPs and ensure appropriate documentation is filed and corrective actions are taken. Identify procedural gaps and drive correction with process improvements where applicable. Conduct and support conduct of vendor qualifications as needed; document and file qualification evidence appropriately. Process Compliance - Ensure CAPA commitments are adequate, submitted and completed in a timely manner. Ensure audits and inspections are supported, tracked and outcomes requiring corrective action are managed. Review CAPAs and make appropriate recommendations to keep consistent actions across GMO. Initiate and document root cause investigations of critical issues. Support the generation and dissemination of Tactical Memos and Lessons Learned communication. Lead the conduct of Trial Master File quality control checks. Ensure GMO compliance with required training by tracking and reporting compliance status for the Global, Regional and Country level organizations. Identify gaps and assign action where needed to promptly gain compliance. 4. Inspection Readiness - Support inspection preparation and execution as well as inspection readiness. Support registration trial readiness by leading the conduct of an annual self-assessment and spot checks for GMO in conjunction with that being done at the OGD Novartis experience in these areas is preferred. Experience working in matrix environment and in global teams. Excellent interpersonal, problem-solving, negotiation and conflict resolution skills. Excellent organizational skills, as well as predisposition to quality management and process improvement Excellent communicator and presenter (oral and written) EDUCATION: Minimum: College or university degree with significant life science experience Desirable: Advanced degree preferably in life sciences