Manager, Commercial GMP QA

Sep 07, 2021

Job Description

9.4 billion spend on Research and Development. That commitment resulted in 24 major regulatory approvals in 2019 in the US, EU, Japan and China.

Major accountabilities
1. Responsible in all below activities for Radio Ligand Therapy (RLT) product and any products related to RLT
2. Ensure all activities of associates comply with company standards and local regulations (cGMP/GQP/GCTP/GDP/QMS/Radiopharmaceuticals) including adequate reporting of adverse events / technical complaint / compliance issue in accordance with company procedures
3. Ensure that a timely and effective communication and escalation process is communicated to and followed by all personnel in the respective area
4. Ensure appropriate interface with authorities for any GxP related activity and provide individual responsibility as a SPOC for health authority if requires, specifically for topics related RLT. Develop and implement Novartis Global Policies, Quality Manual and Technical Guidance in the Country, maintain the quality system and working procedures and quality documents in alignment with AAA standards
5. Lead the preparation and maintenance of Quality activities to ensure GxP and other approvals required to handled Radiopharmaceuticals by applicable authorities
6. Receiving internal/external GMP/QMS audit as key responsible and accompany external auditors Group Quality Manual and Quality Plan implementation follow up to ensure full compliance
7. Contribute to Maintaining and improving Quality Management System in Japan and deliver good performance in line with KPI
8. Manage the following regulatory compliance activity under GQP/QMS Work together with other line functions to keep the compliance of Japan approval files for the RLT products
§ Entering into quality agreement with manufacturing sites, business partners and maintain it
§ Change control related to product quality
§ Oversight GMP manufacturing sites and testing sites from GQP point of view
§ All GMP compliance inspection submission (NDA, PCA, Periodic) OTIF
§ Timely management of periodic regulatory compliance check as a MAH
9. Advocate continuous improvement of quality
Support or lead projects such as new product launch, product transfer, global and/or local initiatives

Minimum Requirements

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Novartis Technical Operations
Full Time

Manager, Commercial GMP QA

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