QA Compliance Specialist
Novartis
June 27, 2026
On-site
Indianapolis, IN
Operations
Key Responsibilities
- Support implementation and oversight of site quality systems aligned with regulatory and Novartis standards
- Lead Quality Management Review activities, including KPI monitoring, reporting, and continuous improvement actions
- Drive inspection readiness programs for internal audits and global health authority inspections
- Facilitate and deliver training on quality assurance compliance programs and requirements
- Support execution of compliance programs, including training, product quality reviews, and compliance alerts
- Provide guidance on audit planning, preparation, and interactions with regulatory authorities
- Partner cross-functionally to ensure adherence to good manufacturing practices, data integrity, and compliance standards
Essential Requirements
- Bachelor’s degree in a scientific or health-related field and at least 5 years of experience in a GMP regulated environment, including at least 3 years in quality compliance in the biopharmaceutical industry with environmental monitoring and cleanliness zones
- Experience establishing and maintaining quality systems and successfully managing inspections from major Health Authorities (USA, EMEA, Canada, Japan, Brazil)
- Quality Assurance experience including Data Integrity (ALCOA+) compliance and technical writing
- Strong knowledge of global regulatory standards (US, EU, ICH)
- Strong communication and organizational skills; ability to manage complex compliance activities across teams
Desirable Requirements
- Experience supporting radioligand or radiopharmaceutical manufacturing operations and associated quality requirements
Relocation/Apply Instructions
- Role is in Indianapolis, United States; Novartis is unable to offer relocation support—apply only if accessible.
- Support implementation and oversight of site quality systems aligned with regulatory and Novartis standards
- Lead Quality Management Review activities, including KPI monitoring, reporting, and continuous improvement actions
- Drive inspection readiness programs for internal audits and global health authority inspections
- Facilitate and deliver training on quality assurance compliance programs and requirements
- Support execution of compliance programs, including training, product quality reviews, and compliance alerts
- Provide guidance on audit planning, preparation, and interactions with regulatory authorities
- Partner cross-functionally to ensure adherence to good manufacturing practices, data integrity, and compliance standards
Essential Requirements
- Bachelor’s degree in a scientific or health-related field and at least 5 years of experience in a GMP regulated environment, including at least 3 years in quality compliance in the biopharmaceutical industry with environmental monitoring and cleanliness zones
- Experience establishing and maintaining quality systems and successfully managing inspections from major Health Authorities (USA, EMEA, Canada, Japan, Brazil)
- Quality Assurance experience including Data Integrity (ALCOA+) compliance and technical writing
- Strong knowledge of global regulatory standards (US, EU, ICH)
- Strong communication and organizational skills; ability to manage complex compliance activities across teams
Desirable Requirements
- Experience supporting radioligand or radiopharmaceutical manufacturing operations and associated quality requirements
Relocation/Apply Instructions
- Role is in Indianapolis, United States; Novartis is unable to offer relocation support—apply only if accessible.