Site QC Head (Associate Director)
Novartis
August 31, 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 per regulatory requirements.
- Establish and optimize laboratory processes, workflows, and quality systems.
- Oversee laboratory 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, budgeting, and resource planning for Global Quality Control Projects; track Global TechOps QC metrics monthly, take required actions, and escalate with action plans to stakeholders.
- Lead inspection readiness and represent Quality Control during regulatory inspections and audits.
- Foster a culture of quality across the Quality team and site, ensuring GMP compliance and continuous improvement.
Essential Requirements:
- Bachelor’s degree in Chemistry, Biology, Pharmacy, Engineering, or related experience.
- 10+ years in pharmaceutical/biotech/regulated industry, including 5+ years leading and developing high-performing teams and prior experience leading a QC organization.
- Strong knowledge of cGMP, QC laboratory operations, and aseptic manufacturing.
- Experience leading regulatory inspections, audits, investigations, and quality system activities.
- Proven ability to drive performance and develop talent.
- 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 approaches (e.g., Lean, Six Sigma, 5S) and leading projects.
Application instructions: Not provided.
- Build and lead a high-performing Quality Control organization across Chemistry, Microbiology, and Incoming Quality.
- Ensure compliant testing and release of materials and products per regulatory requirements.
- Establish and optimize laboratory processes, workflows, and quality systems.
- Oversee laboratory 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, budgeting, and resource planning for Global Quality Control Projects; track Global TechOps QC metrics monthly, take required actions, and escalate with action plans to stakeholders.
- Lead inspection readiness and represent Quality Control during regulatory inspections and audits.
- Foster a culture of quality across the Quality team and site, ensuring GMP compliance and continuous improvement.
Essential Requirements:
- Bachelor’s degree in Chemistry, Biology, Pharmacy, Engineering, or related experience.
- 10+ years in pharmaceutical/biotech/regulated industry, including 5+ years leading and developing high-performing teams and prior experience leading a QC organization.
- Strong knowledge of cGMP, QC laboratory operations, and aseptic manufacturing.
- Experience leading regulatory inspections, audits, investigations, and quality system activities.
- Proven ability to drive performance and develop talent.
- 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 approaches (e.g., Lean, Six Sigma, 5S) and leading projects.
Application instructions: Not provided.