Novartis Job Openings – Life Sciences Quality Manager Vacancy
Novartis Job Openings – Life Sciences Quality Manager Vacancy. MSc Life Science candidates apply online for a PV Compliance and Quality Manager position that is available at Novartis. Novartis is hiring msc candidates, as per the details below in their Research & Development area:
Job Title: PV Compliance and Quality Manager
Job ID: 301886BR
Division: Global Drug Development
Business Unit: CMO & PATIENT SAFETY GDD
Employment Type: Regular
Your key responsibilities:
Your responsibilities include, but are not limited to:
- Develop and implement quality as well as compliance metrics for new safety case management and also aggregate reporting processes, working with the process/metrics owners, Quality Assurance (QA) and other global line functions as appropriate.
- Lead projects to optimize methodologies as well as processes utilized to monitor safety cases and aggregate reports quality in addition to internal and regulatory compliance:.
- Develop as well as maintain tools in collaboration with Innovation, Technology & Systems as well as other Global Line Functions to aid 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 type of changes to worldwide regulations and/or Novartis group processes on existing metrics as well as update as required in order to guarantee continued suitability.
- Review feedback from Health Authorities or other external parties and prepare responses and integrate the feedback into Novartis group standards as appropriate. Handle assigned monitoring activities/ metrics production: Lead investigations into any kind of deficiencies identified, develop as well as implement restorative as well as preventative activities (CAPAs) and also measuring the performance of these.
- Serve as a subject matter expert throughout audits and also inspections (e.g. FDA and also EMA), lead the prep work of responses to searchings for as well as the advancement 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 guarantee the implementation of CAPAs as well as the 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 as well as quality.
Minimum requirements:
What you’ll bring to the role:
- PharmD, MSc degree in life sciences or equal. 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.
- Capability to deal and also interact with a wide variety of people at all levels. Solid organizational skills.
- Strong negotiation, presentation and also communication abilities, and capability to operate effectively in an international environment and across functions.
- Solid analytical abilities, Quality focus and ability to mentor and also coach.
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