Novartis Compliance & Quality Manager Vacancy – D Pharma
Novartis Quality Manager. Novartis DPharma Job D.Pharma Manager job openings. Pharmaceutical Jobs. Applications are invited for the post of Manager@ Novartis. Career @ Novartis Pharma job opening .vacancy at Novartis. Interested candidates may apply online. Novartis Pharma jobs 2020
Job ID 293571BR
Position Title PV Compliance and Quality Manager
Minimum requirements
• PharmD. Fluency in English. Knowledge of other languages desirable.
• Minimum 4 to 7 years of experience in the pharmaceutical industry, particularly pharmacovigilance
• Experience in project management and demonstrated ability to lead working groups in a matrix environment
• Ability to deal and interact with a wide variety of people at all levels. Strong organizational skills
• Strong negotiation, presentation and communication skills, and ability to operate effectively in an international environment and across functions
• Strong analytical skills, Quality focus and ability to mentor and coach
Job Description
Your responsibilities include, but are not limited to:
• Develop and implement quality and compliance metrics for new safety case management and aggregate reporting processes, working with the process/metrics owners, Quality Assurance (QA) and other global line functions as appropriate.
• Lead projects to optimize methodologies and processes used
• Develop and maintain tools in collaboration with Innovation, Tech & Systems and other Global Line Functions to assist in the monitoring of quality and compliance, introducing automation where possible.
• Maintain procedural documents including manuals. Develop and implement training material and communications Assess the impact of any changes to worldwide regulations and/or Novartis group processes on existing metrics and update as required in order to ensure continued suitability.
• Review feedback from Health Authorities or other external parties and prepare responses and integrate the feedback into Novartis group standards as appropriate. Manage assigned monitoring activities/metrics production: Lead investigations into any deficiencies identified, develop and implement corrective and preventative actions (CAPAs) and measuring the effectiveness of these.
• Act as a subject matter expert during audits and inspections (e.g. FDA and EMA), lead the preparation of responses to findings and the development and implementation of CAPAs.
• Collaborate with other Global Line Functions across Novartis Divisions, including Patient Safety Alliance, EU Qualified Person for Pharmacovigilance (QPPV), medical affairs and marketing to ensure implementation of CAPAs and fulfilment of the safety requirements.
• Escalation to CMO&PS leadership and other global line functions as appropriate and/or External Service Providers (ESPs) of compliance/quality issues. Represent CMO&PS externally as a subject matter expert on compliance and quality.
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