Job Description SummaryLocation: Indianapolis, Indiana
Job DescriptionKey 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.
- Ensure appropriate management of QC related validations, transfers, investigations related activities (deviations, OOS, OOE, OOT, CAPAs, trending), and Change Control systems.
- Responsible for business planning, budget and resource planning for the Global Quality Control Projects and follow-up on Global TechOps Quality Control metrics monthly and ensure that required actions taken to achieve the targets and escalate with the action plans to the related stakeholders.
- Direct inspection readiness activities and represent Quality Control during regulatory inspections and audits.
- Foster a culture of quality within the Quality team and across the site ensuring GMP compliance and continuous quality management improvement by facilitating and promoting empowerment and accountability.
Essential Requirements - Bachelor's degree in Chemistry, Biology, Pharmacy, Engineering, or related experience.
- 10+ years of experience within the pharmaceutical, biotechnology, or related regulated industry including at least 5 years of leadership experience building, developing, and leading high-performing organizations including prior experience leading a QC organization.
- Strong knowledge of cGMP regulations, Quality Control laboratory operations, and aseptic manufacturing.
- Demonstrated experience leading regulatory inspections, audits, investigations, and quality system activities.
- Proven ability to drive organizational performance, develop talent, and foster a culture of quality 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 in process improvement approaches (e.g., Lean, Six Sigma, 5s) and leading projects.
The salary for this position is expected to range between $ 138,600 and $257,400 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary 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 health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
To learn more about the culture, rewards and benefits we offer our people click here.
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Salary Range$138,600.00 - $257,400.00
Skills DesiredBusiness Acumen, Collaboration, Data Integrity, Leadership, Manufacturing Production, Stakeholder Management
