Site QC Head (Associate Director)

About this role

Band Level 5  

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 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   a t   least   5 years of leadership experience building, developing, and leading high-performing organizations including p rior experience leading a QC organization.  

• Strong knowledge of c GMP   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 therap ies .  

• 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.    

#LI-Onsite  

  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, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

  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 in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com 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.

https://www.novartis.com/careers/careers-research/notice-all-applicants-us-job-openings

  Salary Range $138,600.00 - $257,400.00   Skills Desired Business Acumen, Collaboration, Data Integrity, Leadership, Manufacturing Production, Stakeholder Management

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