Novartis Pharmaceuticals Corporation is hiring a Global Head RLT Product Lifecycle to ensure the quality and consistency of our groundbreaking Radioligand Therapy (RLT) products throughout their lifecycle. You will bridge clinical, development, and technical operations, providing expert guidance and leadership to maintain the highest quality standards and drive a culture of quality.
What You'll Do
- Ensure the establishment, maintenance, and effectiveness of quality and data management systems and practices, overseeing all aspects of the product lifecycle.
- Lead and manage a global QA organization and/or global quality project team, contributing to and monitoring strategic milestones.
- Ensure adherence to global and local safety, regulatory, and health authority standards.
- Oversee proactive quality risk management processes, including risk assessments and submission/inspection readiness.
- Support inspection preparation and facilitation, and participate in audits and follow-up activities including CAPA preparation.
- Account for the overall product quality strategy, ensuring business continuity and managing product risks across new lines, site transfers, validations, and analytical transfers.
- Provide expert quality guidance and technical support, acting as the global quality lead in product-related escalations, recalls, and BPDR handling.
- Support global site readiness for product pre-approval inspections across the network.
- Maintain global quality oversight on Product Launch, Supply Chain, and Technology Transfers.
- Lead or support major product investigations, particularly multi-site deviations and significant recurring deviations.
- Maintain oversight of the product life cycle, including regulatory filings, registrations, variation management, and technology transfers.
- Secure appropriate management of change controls across sites to ensure consistent product quality and compliance.
What We're Looking For
- Undergraduate degree in Pharmacy, Chemistry, Biology, or a related field.
- 10+ years of experience in GMP-regulated industries, including QA/QC in the Biotech area.
- Working knowledge of FDA, EMA, and ICH regulatory requirements.
- Broad cGMP experience with knowledge of manufacturing, quality control, and validation requirements.
- Ability to synthesize detailed information and communicate clearly across quality, manufacturing, and supply chain functions.
Nice to Have
- Higher level degree.
- Additional knowledge in Quality Assurance and Compliance.
Team & Environment
You will lead and manage a global QA organization and/or a global quality project team.
Benefits & Compensation
- Compensation range: $176,400 - $327,600 per year.
- Full range of medical, financial, and/or other benefits.
- 401(k) eligibility.
- Various paid time off benefits, including vacation, sick time, and parental leave.
- Sign-on bonus.
- Restricted stock units.
- Discretionary awards.
Work Mode
This is a remote position based in the U.S. (remote with possible restrictions based on legal entity).
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion, or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
