Site QC Lead — Radioligand Therapy Manufacturing

Novartis; Indiana (PA); On-site; USD 139,000 - 257,000; Full time

Job summary

Novartis in Indianapolis seeks a Site QC Head to lead a high-performing Quality Control organization across Chemistry, Microbiology and Incoming Quality. You will drive inspection readiness and ensure GMP-compliant testing and release to support patient safety and regulatory success.

The role shapes site strategy, develops talent, and manages budgets/resources for Global QC projects, with clear accountability to stakeholders and senior leadership.

Qualifications

• Bachelor's degree in Chemistry, Biology, Pharmacy, Engineering, or related experience.
• 10+ years in regulated pharma/biotech with at least 5 years in leadership
• Strong knowledge of cGMP, QC lab ops, aseptic manufacturing
• Proven experience leading regulatory inspections, audits, investigations and QA systems
• Proven ability to drive performance, develop talent, foster quality culture
• Direct experience with investigations and root cause analysis in pharma/medical devices

Responsibilities

• Build and lead a QC organization across Chemistry, Microbiology, and Incoming Quality.
• Ensure compliant testing and release of materials/products per regulatory requirements.
• Establish and optimize QC laboratory processes, workflows, and quality systems.
• Oversee QC equipment qualification, analytical methods, and testing program effectiveness.
• Manage QC validations, transfers, investigations (deviations, OOS, OOE, OOT, CAPAs, trending) and Change Control.
• Lead business planning, budget and resource planning for Global QC projects; track metrics and drive actions.
• Direct inspection readiness activities and represent QC during regulatory inspections and audits.
• Foster a culture of quality and GMP compliance site-wide with accountability

Skills

Leadership experience

cGMP knowledge

Quality Control operations

Regulatory inspections

Aseptic manufacturing

Talent development

Education

Bachelor's degree in Chemistry, Biology, Pharmacy, Engineering

Job description

Novartis in Indianapolis seeks a Site QC Head to lead a high-performing Quality Control organization across Chemistry, Microbiology and Incoming Quality. You will drive inspection readiness and ensure GMP-compliant testing and release to support patient safety and regulatory success.

The role shapes site strategy, develops talent, and manages budgets/resources for Global QC projects, with clear accountability to stakeholders and senior leadership.