Site QC Head (Associate Director)
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What you'll do
- 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.
What they're looking for
- 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.
Nice to have
- Experience in Radioligand Therapy manufacturing or other advanced therapies.
- Experience in process improvement approaches (e.g., Lean, Six Sigma, 5s) and leading projects.
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
Job Description Summary
Location: Indianapolis, IndianaJoin Novartis and play a pivotal role in shaping the future of Radioligand Therapy manufacturing. As the Site QC Head, you will lead and inspire a high-performing Quality Control organization at our Indianapolis site, ensuring the highest standards of product quality, patient safety, and regulatory compliance. This is a unique opportunity to influence site strategy, develop exceptional teams, drive inspection readiness, and establish world-class laboratory operations that directly contribute to delivering innovative therapies to patients with serious diseases.
Job Description
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 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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EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Salary Range
$138,600.00 - $257,400.00
Skills Desired
Business Acumen, Collaboration, Data Integrity, Leadership, Manufacturing Production, Stakeholder ManagementCompany
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