769 million. That's how many lives are touched by Novartis products globally. And, while we're proud of that fact, in this world of digital and technological transformation, we must ask ourselves this: how can we continue to improve and extend even more people's lives?
The Senior QA Compliance Specialist is responsible for compliance oversight of manufacturing, testing and supply chain operations with current GMP regulations, procedures, and quality systems.
Your responsibilities include, but are not limited to:
* Work closely with the production, quality control and supply chain departments to ensure their practice fully adheres to cGMP, including data integrity & eCompliance. * Lead and support commercial product FDA/Regulatory interactions for the Indianapolis site activities and products to ensure successful regulatory submissions and audits. * Provide guidance to the site functions on audit planning, preparation and interactions. * Develop, maintain and propose continuous improvement of quality systems such as deviation management, investigations, corrective and preventive actions, change control, complaint management, procedures and training. Ensure these systems are in place and followed efficiently and compliantly. Act as system owner for Quality electronic systems. * Own and manage the escalation process including timely coordination of communications, meetings, documentation and action follow up. Support related communications to Health Authorities when necessary. * Coordinate and perform KPI reporting, APR/PQR reports and customer/third party complaints. * Support oversight and perform supplier qualification processes including onboarding, assessments, auditing an* Provide support to peers within the QA Operations team. * Provide support to peers within the QA Operations team. * Support QA Operations as a valued business partner, with a culture of safety, quality, delivery to patients, cost, compliance, and data integrity.