Novartis is seeking a Product Quality Lead to ensure the quality and consistency of their products throughout their lifecycle, particularly in the area of Radioligand Therapy (RLT), a fusion of nuclear medicine and precision oncology.
Requirements
- Working knowledge of FDA/EMA/ICH regulatory requirements
- Broad cGMP experience with knowledge and understanding of manufacturing, quality control, and validation requirements and activities.
- Ability to synthesize detailed information and clearly communicate across quality, manufacturing and supply chain.
- Undergraduate degree in Pharmacy, Chemistry, Biology or related subject; higher level degree preferred.
- 10+ years’ experience in GMP-regulated industries including QA/QC in Biotech area.
- Additional knowledge in Quality Assurance / Compliance
- Knowledge of manufacturing, quality control, and validation requirements and activities.
Responsibilities
- Ensure establishment, maintenance and effectiveness of quality and data management systems and practices. Oversee all aspects of product lifecycle.
- Lead and manage a global QA organization and/or global quality project team and contribute to and regularly monitor the strategic milestones of the product lifecycle strategy.
- Ensure adherence to global and local safety and regulatory internal and health authority standards.
- Ensure adequate oversight of proactive quality risk management process including quality risk assessments and submission/inspection readiness activities.
- Support inspection preparation and facilitation and participate in audits and inspection follow-up activities including CAPA preparation.
- Accountable for the overall product quality strategy, ensuring business continuity and managing product risks.
- Provide expert quality guidance, technical support and quality leadership.
Other
- Undergraduate degree in Pharmacy, Chemistry, Biology or related subject; higher level degree preferred.
- 10+ years’ experience in GMP-regulated industries including QA/QC in Biotech area.
- Ability to travel approximately 25% of the time (domestic and/or international)
- Ability to work in an ‘at-will position’
- Must be eligible to work in the U.S.
