Site Qc Head (Associate Director)

Novartis; Indiana (PA); On-site; USD 139,000 - 257,000; Full time

Job summary

Novartis in Indianapolis seeks a Site QC Head to lead a high-performing Quality Control organization across Chemistry, Microbiology and Incoming Quality. You will drive inspection readiness and ensure GMP-compliant testing and release to support patient safety and regulatory success.

The role shapes site strategy, develops talent, and manages budgets/resources for Global QC projects, with clear accountability to stakeholders and senior leadership.

Qualifications

• Bachelor's degree in Chemistry, Biology, Pharmacy, Engineering, or related experience.
• 10+ years in regulated pharma/biotech with at least 5 years in leadership
• Strong knowledge of cGMP, QC lab ops, aseptic manufacturing
• Proven experience leading regulatory inspections, audits, investigations and QA systems
• Proven ability to drive performance, develop talent, foster quality culture
• Direct experience with investigations and root cause analysis in pharma/medical devices

Responsibilities

• Build and lead a QC organization across Chemistry, Microbiology, and Incoming Quality.
• Ensure compliant testing and release of materials/products per regulatory requirements.
• Establish and optimize QC laboratory processes, workflows, and quality systems.
• Oversee QC equipment qualification, analytical methods, and testing program effectiveness.
• Manage QC validations, transfers, investigations (deviations, OOS, OOE, OOT, CAPAs, trending) and Change Control.
• Lead business planning, budget and resource planning for Global QC projects; track metrics and drive actions.
• Direct inspection readiness activities and represent QC during regulatory inspections and audits.
• Foster a culture of quality and GMP compliance site-wide with accountability

Skills

Leadership experience

cGMP knowledge

Quality Control operations

Regulatory inspections

Aseptic manufacturing

Talent development

Education

Bachelor's degree in Chemistry, Biology, Pharmacy, Engineering

Job description

Summary

Location: Indianapolis, Indiana

Join 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.

About the Role

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 escape 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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Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards: Learn about all the ways we'll help you thrive personally and professionally. Read our handbook (PDF 30 MB)

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 & 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 [email protected] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.