Site QC Head (Associate Director)
Novartis
August 10, 2026
On-site
Indianapolis, IN
Operations
Key Responsibilities:
- Build and lead a high-performing Quality Control organization across Chemistry, Microbiology, and Incoming Quality.
- Ensure compliant testing and release of materials and products in accordance with regulatory requirements.
- Establish and optimize laboratory processes, workflows, and quality systems to support operational excellence.
- Oversee laboratory equipment qualification, analytical methods, and testing program effectiveness.
- Manage QC validations, transfers, investigations (deviations, OOS, OOE, OOT, CAPAs, trending), and Change Control systems.
- Own business planning, budget, and resource planning for Global Quality Control Projects; track Global TechOps QC metrics monthly, ensure actions to meet targets, and escalate action plans to stakeholders.
- Lead inspection readiness activities and represent Quality Control during regulatory inspections and audits.
- Foster a GMP-compliant culture of quality and continuous quality management improvement through empowerment and accountability.
Essential Requirements:
- Bachelor’s degree in Chemistry, Biology, Pharmacy, Engineering, or related experience.
- 10+ years in pharmaceutical/biotechnology/related regulated industry, including at least 5 years leading and developing high-performing organizations and prior QC leadership.
- Strong knowledge of cGMP, QC laboratory operations, and aseptic manufacturing.
- Demonstrated experience leading regulatory inspections, audits, investigations, and quality system activities.
- Proven ability to drive organizational performance and continuous improvement.
- Direct experience with investigations and root cause analysis in pharmaceutical or medical device products.
Desirable Requirements:
- Experience in Radioligand Therapy manufacturing or other advanced therapies.
- Experience with process improvement (e.g., Lean, Six Sigma, 5S) and leading projects.
Compensation/Benefits (as stated):
- Salary range: $138,600–$257,400/year; performance-based cash incentive; eligibility for annual equity awards depending on level; US comprehensive benefits package including 401(k) and time off.
- Build and lead a high-performing Quality Control organization across Chemistry, Microbiology, and Incoming Quality.
- Ensure compliant testing and release of materials and products in accordance with regulatory requirements.
- Establish and optimize laboratory processes, workflows, and quality systems to support operational excellence.
- Oversee laboratory equipment qualification, analytical methods, and testing program effectiveness.
- Manage QC validations, transfers, investigations (deviations, OOS, OOE, OOT, CAPAs, trending), and Change Control systems.
- Own business planning, budget, and resource planning for Global Quality Control Projects; track Global TechOps QC metrics monthly, ensure actions to meet targets, and escalate action plans to stakeholders.
- Lead inspection readiness activities and represent Quality Control during regulatory inspections and audits.
- Foster a GMP-compliant culture of quality and continuous quality management improvement through empowerment and accountability.
Essential Requirements:
- Bachelor’s degree in Chemistry, Biology, Pharmacy, Engineering, or related experience.
- 10+ years in pharmaceutical/biotechnology/related regulated industry, including at least 5 years leading and developing high-performing organizations and prior QC leadership.
- Strong knowledge of cGMP, QC laboratory operations, and aseptic manufacturing.
- Demonstrated experience leading regulatory inspections, audits, investigations, and quality system activities.
- Proven ability to drive organizational performance and continuous improvement.
- Direct experience with investigations and root cause analysis in pharmaceutical or medical device products.
Desirable Requirements:
- Experience in Radioligand Therapy manufacturing or other advanced therapies.
- Experience with process improvement (e.g., Lean, Six Sigma, 5S) and leading projects.
Compensation/Benefits (as stated):
- Salary range: $138,600–$257,400/year; performance-based cash incentive; eligibility for annual equity awards depending on level; US comprehensive benefits package including 401(k) and time off.