Head of QA Operations (Assoc Dir level)
$138,600–$257,400 year
On-siteIndianapolis, Indiana, United States
Job Summary
Lead the QA Operations organization, providing quality oversight for Drug Product Manufacturing and Quality Control operations, including 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, promote inspection readiness, and lead investigations, deviations, corrective actions, and change controls to resolve quality issues effectively. Prepare and deliver validation plans supporting compliant manufacturing and quality operations while managing FDA interactions and commercial product field actions. Build high-performing teams, coach leaders, and partner cross-functionally to achieve production goals and drive continuous improvement initiatives.
Required Qualifications
- Bachelor of Science in Chemistry, Biology, Pharmacy, Biochemistry, Engineering, or related experience
- 10+ years of experience in Quality Assurance, Quality Control, Quality Systems, Compliance, or operational GxP area (Manufacturing / Development) within the pharmaceutical, diagnostic, or medical device industries
- Prior experience leading a Quality Assurance organization, including developing high-performing teams and talent
- Prior experience supporting aseptic pharmaceutical manufacturing operations
- In-depth knowledge of current GMPs, Quality Assurance, Quality Control, and applicable regulatory requirements and standards
- Direct experience conducting investigations and root cause analysis for pharmaceutical or medical device products
- Experience reviewing manufacturing and Quality Control validation documents and supporting validation activities in a regulated environment
- Proven experience leading Health Authority inspections and audits within a regulated manufacturing environment
Desired Qualifications
- Experience in advanced therapy platforms, including Radioligand Therapy, Cell and Gene Therapy, or other novel therapeutic technologies
- Experience with continuous improvement methodologies such as Lean, Six Sigma, or 5S and leading projects
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