QA Manager, Quality Management Systems, Quality, Sumitomo Pharma Oncology Inc., Malborough, MA: Will be responsible for administration and oversight of select electronic quality systems such as Audit Management, Supplier Quality, Deviation and CAPA, and metrics and product quality complaints. Manage Document and quality records management processes including authoring SOPs, electronic document management system maintenance. Manage all Product Complaints and collaborate with the internal stakeholders (GMP/ CMC, PV, Clinical, etc.) and ensure successful execution through tracking, trending and general oversight for compliance. Manage MasterControl (eQMS) System administration duties, including account administration, change control, ability to run complex queries. Manage Product Complaints including documenting complaints, conducting thorough investigations with external vendors, healthcare providers, or internal cross functional teams. Manage Quality Records file room. Manage Design History File records such as SOPs and forms and ensure they are managed and maintained within the QMS system. Maintain Design History File repository within eQMS. Responsible for routine reporting of Quality metrics to monitor performance to support and provide recommendations to senior management for continuous improvement. Ensuring quality systems are maintained and improved to give a high level of service (e.g. delivery of compliance objectives, risk based supplier quality management). Maintain up to date quality records such as deviations, investigations, CAPA, change control, complaint document and record control and training as related to quality operations. Administer and execute appropriate electronic quality management systems for deviations, investigations, CAPA, Quality Complaints, metrics, product review and release, training and risk management. Work with cross functional groups to help evaluate and address procedural documentation needs and gaps. Telecommuting from within the U.S. allowed. Minimum Requirements: Bachelor’s degree in Regulatory Affairs or a closely related field and 3 years’ professional experience in quality assurance for the pharmaceutical industry. Special Requirements: Must have any level of demonstrated knowledge of: 1) cGMP compliance; 2) electronic data management system for Quality events; and 3) test methods, validation protocols, and stability studies. Qualified applicants email resume to Kristen Quagliozzi, Senior Director, Talent Acquisition and HR Business Partner, Sumitomo Pharma Oncology at email@example.com with reference to Job Code: SPOQAM22.