Head of QA Operations (Assoc Dir level)
Novartis
August 11, 2026
On-site
Indianapolis, IN
Operations
Head of QA Operations (Quality Assurance Operations)
Key Responsibilities
- Lead the QA Operations organization, providing quality oversight for Drug Product (DP) Manufacturing and Quality Control operations (Shop Floor QA, QA Engineering, and final product disposition).
- Ensure compliant and timely product disposition decisions while maintaining patient safety and regulatory compliance.
- Drive quality oversight across manufacturing operations to promote inspection readiness and operational excellence.
- Lead resource allocation, capacity planning, and operational prioritization to support quality, compliance, and business objectives.
- Lead investigations, deviations, corrective actions, and change controls.
- Ensure preparation, review, and delivery of validation plans supporting compliant manufacturing and quality operations.
- Support escalation management, FDA interactions, and commercial product field actions while maintaining inspection readiness.
- Build, coach, and develop high-performing leaders and teams while strengthening site quality culture.
- Partner cross-functionally to achieve production goals, address risks, and support business priorities.
- Monitor quality performance metrics and drive continuous improvement.
Essential Requirements
- BS in Chemistry, Biology, Pharmacy, Biochemistry, Engineering, or related experience.
- 10+ years in Quality Assurance/Quality Control/Quality Systems/Compliance or operational GxP area in pharma/diagnostics/medical devices.
- Prior experience leading a Quality Assurance organization and developing teams.
- Prior experience supporting aseptic pharmaceutical manufacturing.
- In-depth knowledge of current GMPs and applicable regulatory requirements.
- Direct experience conducting investigations and root cause analysis.
- Experience reviewing manufacturing and QC validation documents.
- Proven experience leading Health Authority inspections and audits.
Desirable Requirements
- Experience in advanced therapy platforms (e.g., Radioligand Therapy, Cell & Gene Therapy).
- Experience with Lean, Six Sigma, or 5S and leading improvement projects.
Key Responsibilities
- Lead the QA Operations organization, providing quality oversight for Drug Product (DP) Manufacturing and Quality Control operations (Shop Floor QA, QA Engineering, and final product disposition).
- Ensure compliant and timely product disposition decisions while maintaining patient safety and regulatory compliance.
- Drive quality oversight across manufacturing operations to promote inspection readiness and operational excellence.
- Lead resource allocation, capacity planning, and operational prioritization to support quality, compliance, and business objectives.
- Lead investigations, deviations, corrective actions, and change controls.
- Ensure preparation, review, and delivery of validation plans supporting compliant manufacturing and quality operations.
- Support escalation management, FDA interactions, and commercial product field actions while maintaining inspection readiness.
- Build, coach, and develop high-performing leaders and teams while strengthening site quality culture.
- Partner cross-functionally to achieve production goals, address risks, and support business priorities.
- Monitor quality performance metrics and drive continuous improvement.
Essential Requirements
- BS in Chemistry, Biology, Pharmacy, Biochemistry, Engineering, or related experience.
- 10+ years in Quality Assurance/Quality Control/Quality Systems/Compliance or operational GxP area in pharma/diagnostics/medical devices.
- Prior experience leading a Quality Assurance organization and developing teams.
- Prior experience supporting aseptic pharmaceutical manufacturing.
- In-depth knowledge of current GMPs and applicable regulatory requirements.
- Direct experience conducting investigations and root cause analysis.
- Experience reviewing manufacturing and QC validation documents.
- Proven experience leading Health Authority inspections and audits.
Desirable Requirements
- Experience in advanced therapy platforms (e.g., Radioligand Therapy, Cell & Gene Therapy).
- Experience with Lean, Six Sigma, or 5S and leading improvement projects.