Quality Operations Lead
Novartis
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $168,000 - $312,000 per year
Job Level
Senior
About the role
- Provide strategic leadership for quality operations across US radioligand therapy manufacturing sites.
- Define and implement the operating model for US quality operations, including organization design and performance management.
- Ensure compliance with current Good Manufacturing Practice (cGMP) standards and global Novartis quality policies.
- Ensure robust product quality oversight for RLT products, including radiopharmaceutical-specific controls, aseptic and sterile manufacturing practices, and distribution considerations.
- Champion safety, ethical compliance, and patient-centric decision making in all quality activities.
- Lead inspection readiness and successful execution of health authority, customer, and internal inspections.
- Oversee site-level Quality functions (e.g., QA Operations, QC Laboratories, Batch Release, Deviation/Investigation Management, Change Control, Supplier Quality, Validation, Documentation Control).
- Partner with Manufacturing, Supply Chain, MS&T, Regulatory Affairs, EHS, and Global Quality to enable reliable, compliant supply to US and international markets.
- Drive harmonization of quality systems and digital tools across sites, promoting data integrity and lifecycle management.
Requirements
- Bachelor’s degree in a scientific discipline required; advanced degree preferred.
- Minimum 10 years of progressive quality experience in pharmaceuticals or biologics, with at least 7 years in radiopharmaceuticals or sterile/aseptic operations.
- Previous experience as a Site Quality Head.
- Working knowledge of Food and Drug Administration (FDA), European Medicines Agency (EMA), and International Council for Harmonization (ICH) regulatory requirements.
- Proven track record of successful regulatory inspections, corrective and preventive action (CAPA) management, and quality system deployment.
- Strong people leadership skills, including team building, talent development, and stakeholder management.
Benefits
- health insurance
- life and disability benefits
- 401(k) with company contribution and match
- generous time off package including vacation, personal days, holidays and other leaves
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
quality operationsGood Manufacturing Practice (cGMP)radiopharmaceutical-specific controlsaseptic manufacturing practicessterile manufacturing practicesBatch ReleaseDeviation ManagementChange ControlSupplier QualityValidation
Soft skills
strategic leadershipperformance managementsafety complianceethical compliancepatient-centric decision makinginspection readinessteam buildingtalent developmentstakeholder management