Site QC Head (Associate Director)

Regulatory Toolkit; Indianapolis (IN); On-site; USD 139,000 - 257,000; Full time

Benefits offered by this job

Comprehensive benefits

401(k) with company match

Paid time off and holidays

Job summary

Novartis is seeking a Site QC Head in Indianapolis to lead a high-performing Quality Control organization across Chemistry, Microbiology and Incoming Quality. You will drive compliance, establish robust lab processes, and oversee validation, investigations and CAPA programs to ensure patient safety and product quality.

You will direct inspection readiness, collaborate with stakeholders, and foster a culture of quality and continuous improvement within GMP environments.

Qualifications

• Bachelor's degree in Chemistry, Biology, Pharmacy, Engineering, or related field.
• 10+ years in pharma/biotech, with 5+ years in leadership building QC teams.
• Strong knowledge of cGMP, QC lab operations, and aseptic manufacturing.
• Experience directing regulatory inspections, audits, and quality systems.
• Proven ability to develop talent and drive quality improvements.
• Direct experience with investigations and root cause analysis.

Responsibilities

• Build and lead a high-performing QC organization across Chemistry, Microbiology, and IQ.
• Ensure compliant testing and release of materials and products per regulations.
• Establish and optimize QC laboratory processes, workflows, and quality systems.
• Oversee equipment qualification, methods, and testing program effectiveness.
• Manage QC validations, transfers, investigations (deviations, OOS, CAPAs).
• Lead budgeting and resource planning for Global QC projects and metrics.
• Lead inspection readiness activities and represent QC during inspections.
• Foster a culture of quality and continuous improvement across site.

Skills

Business Acumen

Collaboration

Data Integrity

Leadership

Manufacturing Production

Stakeholder Management

Education

Bachelor's degree

Job description

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.

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 materialsandproductsin 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 elevate 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 $257,400per 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 therole, eligibility to be considered for annual equity awards.US-based eligible employees will receive a comprehensive benefits package that includes health,lifeanddisability benefits, a 401(k) with company contribution and match, and a variety of other benefits. Inaddition, employees are eligible for a generous time off package including vacation, personal days,holidaysand 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 [e-mail] 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.

Salary Range

$138,600.00 - $257,400.00

Skills Desired

Business Acumen, Collaboration, Data Integrity, Leadership, Manufacturing Production, Stakeholder Management