QA Compliance Specialist

Novartis • Indianapolis, IN

2d • $89,600 - $166,400 • Onsite

About The Position

Play a pivotal role in ensuring the highest standards of quality and compliance in a cutting-edge radioligand therapy environment. As a QA Compliance Specialist, you will help shape and sustain robust quality systems that enable safe, reliable, and inspection-ready operations. Partnering across site functions, you’ll drive compliance excellence, support regulatory readiness, and contribute to continuous improvement—making a direct impact on delivering innovative therapies to patients.

Requirements

• Bachelor’s degree in a scientific or health-related field
• At least 5 years of experience in a GMP regulated environment
• At least 3 years of experience in quality compliance in the biopharmaceutical industry with environmental monitoring and cleanliness zones
• Experience in establishing and maintaining quality systems
• Successfully managing inspections from major Health Authorities including USA, EMEA, Canada, Japan, Brazil
• Previous Quality Assurance experience must include Data Integrity, (ALCOA+) compliance, and technical writing
• Strong knowledge of global regulatory standards, including United States, European Union, and International Council for Harmonization requirements
• Strong communication and organizational skills, with ability to manage complex compliance activities across teams

Nice To Haves

• Experience supporting radioligand or radiopharmaceutical manufacturing operations and associated quality requirements

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

Benefits

• health, life and disability benefits
• a 401(k) with company contribution and match
• a variety of other benefits
• a generous time off package including vacation, personal days, holidays and other leaves

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level