US-NJ, US CPO IMP Release Manager 210363BR_1491839455-MZ
|Responsible for the release of clinical supplies at the country level for global and local studies conducted in the US. Ensure compliance of the CPO organization with cGMP legal and regulatory requirements and the Novartis Quality Manual and Policies. |
• Ensure that all aspects of the handling, manufacturing and distribution of investigational medicinal products (IMP) in the country comply with the requirements of the Novartis Quality Manual and Policies and meet all relevant cGMP regulatory and legislative requirements.
• Ensure that all Investigational Medicinal Products (IMP) are released for use in accordance with the registered specifications and with local/international regulations.
• Responsible for the timely release of Investigation MedicinaI Products (IMPs) to clinical study sites and assuring compliance with local and global regulatory requirements. Activities include evaluation of study site regulatory compliance to receive study medication, frequent interactions with all functional areas and contracting companies.
• Report monthly Key Quality Indicators (KQIs) related to GMP/GDP activities to CPO QA and monitor them and assure that gaps are addressed appropriately in order to mitigate risk.
• Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that technical support on all quality related matters is provided to the country.
• Establish a good working relationship with the Drug Supply Management and Regulatory Affairs departments.
• Ensure that coordinated contact is maintained with the Regulatory Authorities, the local partners (suppliers, third parties, licensees, and distributors) and Global Quality Assurance.
• Ensure quality oversight of third party and coordinate all required activities to guarantee that third party manufacture, (re-)packaging, (re-)labelling, storage and/or distribution of Novartis products is in compliance with Novartis Standards.
• Establish good working relationship with vendors in order to keep QA oversight on all partners (e.g. third party activities).
• Ensure CPO readiness for all internal/external audits and regulatory inspections.
• Manage external inspections, complaints, deviations, recalls, counterfeits and product tampering according to the Novartis Corporate Quality Manual and local written procedures. Ensure relevant CAPAs have been completed/closed.
• BSN, BA or BS degree in Life Sciences or related fields
• Minimum 5 years of experience in the pharmaceutical industry in a relevant field such as quality assurance, quality control, registration, production, distribution or a directly related area.
• English fluent in speaking and writing.
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