Hiring: Associate Director, Quality Operations Company: Simtra BioPharma Solutions Location: Bloomington, IN Job Posted Time: 2026-09-10 13:51:40 Employment Type: Contract Target Skills & Keywords : Microsoft Excel About the job Experience: •8 years’ experience in Quality or pharmaceutical industry experience. •5 years’ experience in a management role. •Minimum 8 years’ experience in Quality or pharmaceutical industry experience. •Minimum 5 years’ experience in a management role. Required Skills: •Single point of Quality Operations accountability for the assigned Focus Factory, from manufacturing readiness through batch disposition and release. •Provides independent quality oversight and quality decision-making for routine operations, escalations, deviations, CAPA effectiveness, and inspection readiness. •Serves as an empowered Quality Leader and designee to the Quality Director for defined reviews, approvals, Quality Review Board endorsements, and escalation forums, as delegated by procedure or written delegation. •Partners with other cross Focus Factory quality functions, Manufacturing, Technical Services, Engineering, Supply Chain, QC, Regulatory, and Client Services to ensure quality, compliance, supply continuity, and patient safety are appropriately balanced and documented. •Establish clear quality priorities, resource plans, and coverage models to support 24/7 operations, including manufacturing floor support, real-time quality decision-making, and timely escalation of quality risks. •Provide guidance, support, direction, and leadership through positive interactions with all personnel during daily operations. •Ensure the Focus Factory quality organization operates with strong ownership, accountability, and alignment to site quality strategy, operational goals, client commitments, and regulatory expectations. •Develops department annual budget and ensures spending within expected quarterly forecasts. Qualifications: •Bachelor's degree required preference in a Life Science field; advanced degree preferred. •Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.) •Must be able to qualify for entry into Class A/B aseptic facilities. •Must wear appropriate personal protective equipment as applicable. •Duties may require overtime work, including nights and weekends •Use of hands and fingers to manipulate office equipment is required •Position requires sitting for long hours but may involve walking or standing for periods of time. •In return, you’ll be eligible for [1] 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!