Manage Quality Assurance (QA) activities within the Operating Unit (OU) and nominated third parties to ensure compliance OTC products throughout their Product Lifecycle with Novartis Quality Manual and all relevant regulatory and legislative requirements. Ensure timely product disposition in compliance with all applicable regulatory and legislative requirements.
Lead the development, maintenance and rolling review of quality systems within the OU to support the OU business continuity. Implement quality action plans at local third parties and OU to minimize business risks. Establish and maintain Quality Systems for the OU; ensure that Standard Operating Procedures are in place and that compliance with cGMP is maintained through ongoing training and internal audits. Monitor and evaluate the level of cGMP compliance for products manufactured, packaged, tested and released at local and regional (delegated) third parties through Key Performance Indicators (KPIs) and Key Quality Indicators (KQIs).
Continuously improve and harmonise the OU Quality Systems, strengthen quality awareness, implement the development of local third party strategic plans, support local third party contract facilities, contract operation, technical services, process improvements, product quality review, eliminate barriers and proactively investigate quality issues using appropriate process improvement and problem solving techniques.
Perform duties of the Qualified Person or Responsible Pharmacist or Duty of Care Quality Assurance Manager for the nominated NCH site in compliance with EU GMP regulations and directives, where applicable.
Ensure that all new product launches and commercial BD&L projects are in line with Novartis Corporate GMP requirements and actively provide strategic direction to support the OU business targets in close collaboration with regional Category QA team.
Ensure that the OU QA activities operate in a cost effective and efficient manner and maintain an innovative approach based on productivity improvement and implementation of best practice.
Applicants must apply online at www.novartis.com. Only on-line application materials will be considered. If you require accommodation under the Americans with Disabilities Act to apply for this position, please contact (402) 467-8802.
• Graduate in Chemistry, Pharmacy, Microbiology or another related science, business degree is a plus.
• Minimum 7-10years experience in pharmaceutical industry.
Novartis AG, incorporated on February 29, 1996, is a Switzerland-based holding that, through its subsidiaries, is engaged in the research,...