Manager, QA System Management

About the role

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary Accountable for support and manage Quality Management System (QMS) in accordance with regulatory requirements and to ensure the adherence to the Quality Manual. Responsible to ensure efficiency, accuracy and standardization in high commitment level for document management and data integrity. The incumbent is responsible for authoring, review and manage the development of internal procedures to ensure adherence to the implementation of global and harmonized Quality Standards and regulatory requirements for GMP area. Responsible for the creation and review Quality Assurance Agreements with contract organization and to manages a Quality Assurance Agreement system which provides a realistic and accurate information to oversee and support vendor qualification program and the relationship with contract organizations. Collect, conduct and evaluate data for critical operations related with Annual Product Reviews. Manages the completion of stability studies program of drug products marketed in US and exported from US.

Responsibilities

• Quality Assurance Agreements: Manages a comprehensive system for the establishment of local and global Quality Assurance Agreements in order to assure that all external contractors involved in manufacturing and testing of drug products for commercial and investigational purposes, drug substances, intermediates and service providers provide GMP compliant activities ensuring the stable and quality supply as per local and international regulations and guidelines satisfying DS requirements and supporting the company’s vision. Ensure proactive planning and completion for QA Agreements establishment and review process in a timely manner as necessary.
• Change Control System: Manages an effective Change Control System able to capture and deal with changes proposed by manufacturers, customers, internal improvements and/or Health Authorities requirements. Responsible to communicate in timely-manner with several internal and external partners and functions in order to properly address all the proposed changes, ensuring the right QA assessment and looking for the best strategy to avoid any impact for commercial and investigational products availability in order to cover patient needs.
• CAPA Management: Ensure oversight for CAPA Management activities in order to define and follow the completion plan up. Responsible to communicate in timely-manner with several internal and external partners and functions in order to ensure the deadline of CAPA plan is followed on rigor as per defined in the internal procedures.
• Product Data Management: Responsible to collect and/or evaluate data information from critical manufacturing steps process and authoring Annual Product Review as per internal procedures and current regulatory requirements tracking all the complaints, deviations and change control related with the product and creating a trend evaluation scenario to ensure that products are following high quality standards to meet patient needs. Responsible to lead the activities related with stability studies program performance in accordance with internal procedures and regulatory requirements in connection with contract testing laboratories to ensure the compliance for products marketed and/or distributed locally. May author or review stability studies protocol or reports. Provide the support for management and update of technical registration documents.
• Quality Metrics: Collecting and analyzing data related to deviations, CAPA, Change Controls, OOS, and internal/external audits performance and reporting Quality Metrics in a periodical manner and communicate this to Senior Management handling Quality Meeting sessions, identifying potential quality issues and proposing suitable solutions fostering a preventive mindset across the team and to the organization based on the metrics collected.
• Development of Standards and Procedures (SOPs) and Training: Liaise with GMP areas to ensure adequate procedural documents directly impacting area of responsible and/ or other GMP areas as assigned. Responsible to adhere and implement key global/regional QA GMP Standards, Procedures and Instructions. Supporting SOP authoring and reviewing process among GMP functions. Responsible to provide enough training for the related GMP and non-GMP activities involved with QA System