Site QC Head (Associate Director)

Site QC Head (Associate Director)

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 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.