Hiring: Site QC Head (Associate Director) Company: Novartis Location: Indianapolis, IN Job Posted Time: 2026-09-03 10:21:06 Target Skills & Keywords : Regulatory Compliance About the job 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. •At least 5 years of leadership experience building, developing, and leading high-performing organizations including prior experience leading a QC organization. Required Skills: •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. •Lead and oversee 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. Qualifications: •Bachelor’s degree in Chemistry, Biology, Pharmacy, Engineering, or related experience. •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. •To learn more about the culture, rewards and benefits we offer our people click here. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!