QA Compliance Manager

766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. <br>We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!<br>Imagine what you could do here at Novartis!<br><br>The QA Compliance Manager is responsible for designing and implementing robust Quality Systems for the Advanced Accelerator Applications Indianapolis site considering current GMP regulations and procedures.<br><br>Your responsibilities include, but are not limited to:<br><br>• Provide Compliance oversight of all GxP activities to ensure their practice fully adheres to cGMP, including data integrity. Ensure timely escalation to management of all applicable incidents.<br>• Ensure the Compliance team is fully staffed to support site GxP activities. Hire and supervise internal and external staff.<br>• Contributes, significantly, to the architecture of quality management systems, will author or contribute to the procedures governing these systems and will work towards timely implementation, providing expertise and participating fully in the management of health authority inspections.<br>• Provide quality input on the design and architecture of Quality System.<br>• Provide daily leadership and management for the Quality Systems team.<br>• Responsible for contributing to the development of robust quality systems, including both implementation and operation.<br>• Participate in global projects to optimize quality management systems and workflows.<br>• Act as liaison between GMP, GLP, GCP, GVP and business units to ensure compliance and harmonization.<br>• Manage and prioritize on-going continuous improvement projects directly related to Quality Systems to support business needs.<br>• Review and approve global change controls, deviations and CAPA and perform effectiveness checks.<br>• Participate in Periodic conformance audits of the operations of the system.<br>• Act as representative in monthly Quality Management Review meeting (QMR) to review plant metrics, ensure a state of control and drive action where appropriate along with reporting on a specific set of quality and compliance metrics.<br>• Support QA Compliance team as a valued business partner, with a culture of safety, quality, delivery to patients, cost, compliance and data integrity.<br>• Other related duties as assigned.<br><br>The pay range for this position at commencement of employment is expected to be between $112,800.00 and $169,200.00 per year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.<br><br>https://www.youtube.com/watch?v=ggbnzRY9z8w[#video#https://www.youtube.com/watch?v=ggbnzRY9z8w{#400,300#}#/video#]