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Site QC Head (Associate Director)

Job Overview

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Compensation

Salary
Range $138,600.00 - $257,400.00
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Benefits

Health Insurance
Life insurance
Disability insurance
401(k) Plan
Paid Time Off
Performance-based cash incentive
Equity awards

Job Description

Novartis is a global healthcare leader based in Indianapolis, Indiana, dedicated to reimagining medicine and advancing innovative therapies that improve and extend patients' lives. With a commitment to scientific excellence and patient-centric approaches, Novartis operates across various scientific fields including pharmaceuticals, radioligand therapy, and biotechnology, striving to provide transformative solutions to some of the world's most challenging diseases. As a reputable multinational pharmaceutical company, Novartis offers a dynamic and inclusive working environment where innovation, collaboration, and quality are at the core of its organizational values. The company is committed to diversity and equal opportunity employment, supporting employees through comprehensive benefits and fostering a culture of continuous growth and development.

The role of Site QC Head at the Indianapolis site is pivotal within Novartis’ Radioligand Therapy manufacturing operations. This leadership position involves directing the Quality Control organization and ensuring adherence to highest standards of quality, safety, and regulatory compliance. The appointed professional will lead diverse teams across Chemistry, Microbiology, and Incoming Quality, focusing on rigorous testing and release of materials compliant with current Good Manufacturing Practices (cGMP). This opportunity is ideal for an experienced leader passionate about optimizing laboratory operations and driving inspection readiness. The Site QC Head plays a critical role in shaping site strategy, managing budgets and resources, and continuously improving quality systems to support operational excellence. With responsibilities that include oversight of equipment qualification, analytical method validation, and change control systems, this position directly influences the delivery of innovative therapies that meet stringent regulatory standards and patient needs. Novartis offers this full-time role with a competitive salary range from $138,600 to $257,400 per year, complemented by performance-based incentives, equity award eligibility, and a comprehensive benefits package that includes health, life, and disability insurance, 401(k) with company contributions, generous paid time off, and employee-oriented wellness initiatives. Joining Novartis means becoming part of a global team that is committed to making impactful changes in healthcare through high-quality pharmaceutical manufacturing and relentless pursuit of quality and compliance.

Job 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

Job Qualifications

  • 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

Job Duties

  • 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

Job Criteria

Experience

Expert Level (7+ years)


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