The Role:We are seeking a Senior Specialist, Quality Systems and Compliance to provide quality expertise to support our QS&C team for the development and commercialization of Deciphera’s products in compliance with relevant US, EU and ICH requirements.  The primary responsibilities of this role will be supporting the Quality Systems and Compliance department to ensure GxP compliance.  We are looking for a teammate that can partner with internal departments to support the Document Control (eDMS), Learning Management System (LMS), and Quality Management Systems (QMS), and to implement process improvements to meet business and regulatory requirements.  This position will report to the Associate Director, Quality Systems and Compliance and can be performed remotely within the US.What You’ll Do:Supports the day-to-day management of the Quality Systems and Compliance department, including the Document Control function.Assist with the development and implementation of Quality Systems SOPs, Work Instructions, training materials and reference guides.Assists in delivery, maintenance, and continuous improvement of cross-GxP processes in eDMS, LMS, and QMS.Generate compliance metrics and prepare routine KPI reports.Participate in system validation activities as required.Assist in the identification and implementation of continuous improvement opportunities.Build and maintain relationships with other departments and establish a culture of engagement and transparency with Quality.Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.Participate in regulatory inspections for our global clinical and commercial programs as needed.
