Head of QA Operations (Assoc Dir level)

Key Responsibilities

• Lead the QA Operations organization providing quality oversight for Drug Product (DP) Manufacturing and Quality Control operations including Shop Floor QA QA Engineering and final product disposition.

• Ensure compliant andtimelyproduct disposition decisions whilemaintainingpatient safety and regulatory compliance.

• Drive quality oversight across manufacturing operations promotinginspectionreadiness and operational excellence.

• Lead resource allocation capacity planning and operational prioritization to support quality compliance and businessobjectives.

• Lead investigations deviations corrective actions and change controls to resolve quality issues effectively.

• Ensure preparation review and delivery of validation plans supporting compliant manufacturing and quality operations.

• Support escalation management FDA interactions and commercial product field actions whilemaintaininginspectionreadiness.

• Build coach and develop high-performing leaders and teams while strengthening site quality culture.

• Partner cross-functionallyto achieve production goals address risks and support business priorities.

• Monitor quality performance metrics and drive continuous improvement initiatives to strengthen compliance and execution.

Essential Requirements

• 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 operationalGxParea(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.

Desirable Requirements

• Experienceinadvancedtherapy 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 leadingprojects.

The salary for this position is expected to range between $138600and $257400per year.The final salary offered isdeterminedbased on factors like but not limited to relevant skills andexperience and upon joiningNovartiswill be reviewed periodically. Novartis may change the publishedsalary range based on company and market factors.

Your compensation will include a performance-based cash incentive and depending on the level of the

role eligibility to be considered for annual equity awards.US-based eligible employees will receive a comprehensive benefits package that includes healthlifeanddisability benefits a 401(k) with company contribution and match and a variety of other addition employees are eligible for a generous time off package including vacation personal daysholidaysand other leaves.

To learn more about the culture rewards and benefits we offer our people clickhere.

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