QA Operations Supervisor

Job Description Summary

Help reimagine cancer care by shaping how our Radioligand Therapies (RLT) reach more patients—safely, reliably, and faster. At Novartis, we're pioneering the future of treatment through the fusion of nuclear medicine and precision oncology.

The QA Operations Supervisor provides hands‑on support for shop floor quality oversight and batch release activities while acting as supervisor to the QA Operations and Batch Release Specialists of their shift.

Location:

Indianapolis, IN #LI-Onsite

Shift: Night Shift. weekend nights included

• Provide direct supervision of QA Operations Specialists and QA Batch Release Specialists, ensuring alignment with site quality objectives.
• Coordinate daily activities, prioritize workload, and ensure timely completion of QA tasks across both functions.
• Serve as the primary point of contact for quality‑related issues during assigned shifts, ensuring timely escalation and resolution.
• Ensure shopfloor quality oversight of production, QC, and supply chain activities, verifying adherence to cGMP, aseptic techniques, and data integrity standards.
• Oversee live review of manufacturing batch records and documentation to support timely and compliant batch release.
• Confirm compliance of site personnel with sterile manufacturing regulations and internal procedures.
• Support the release of all manufactured, packaged and tested materials.
• Support the controlled issuance of batch records in preparation for manufacturing.
• Perform review of manufacturing batch records in preparation for batch release and elevate any discrepancies immediately.
• Support metric tracking of documentation and release data to ensure continuous improvement.
• Support all QA operations as a valued business partner, fostering a culture of safety, quality, delivery to patients, cost, compliance, and data integrity.
• Provide Quality Oversight on Deviation, Change Control, and CAPA management.
• Maintain batch documentation library (record check‑in, check‑out, follow‑up, and distribution).
• Perform live review of manufacturing batch records in preparation for batch release and escalation of any discrepancies.

• Bachelor's Degree, preferably in Life Sciences, chemistry, or a related degree. In lieu of a degree, 5 years in a role within the pharma industry that includes quality assurance and batch release experience will be considered.
• 3+ years of experience in GxP biopharmaceutical manufacturing operations.
• 2+ years of experience in a quality assurance role.
• Cross‑functional collaboration, QA and QC experience in the biotech/pharmaceutical industry with environmental monitoring & cleanliness zones is desired.
• Proven track record and practical experience with cGMP requirements.
• Knowledge of FDA and EU regulations and experience during US and international regulatory agency inspections.

The salary for this position is expected to range between $89,600 and $166,400 per year. The final salary offered will be determined based on relevant skills and experience and reviewed periodically. Your compensation will include a performance‑based cash incentive and, depending on the level of the role, eligibility 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. Employees also enjoy generous time‑off packages, including vacation, personal days, holidays, and other leaves.

The Novartis Group of Companies is an Equal Opportunity Employer. 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.

The Novartis Group of Companies is committed to working with and providing reasonable accommodations 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 this position, please email us.reasonab or call . Please include the job requisition number in your message.

• Continued Learning
• Dealing With Ambiguity
• GMP Procedures
• Quality Assurance (QA)
• Quality Control (QC) Testing
• Quality Standards
• Self‑Awareness
• Technological Expertise
• Technological Intelligence