Daiichi Sankyo Inc. Manager of IMP-GMP in Basking Ridge, New Jersey
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Job Summary :
Contribute and implement the improvement of Daiichi Sankyo’s Quality Management Systems, both locally and globally in addition to management and coordinating. This includes but is not limited to managing the West Regional GxP Procedural Document Program, employing industry best practices and management solutions to support the appropriate documented procedures for activities and processes required to meet Daiichi Sankyo and Regulatory expectations are in place and the document lifecycle is appropriately managed.
Provide oversight and coordinate the Global R&D SOP committee (GRDSOPC) office activities from QA perspective including coaching on the western compliance expectations to the East members to lead the committee successfully. Also the incumbent participates in the efforts to globalize Daiichi Sankyo procedures via the GRDSOPC, and coordinates with West functions to ensure alignment of Global SOPs with West Regional procedures.
Provide leadership and facilitate the Global QA SOP management system in collaboration with other key personnel within the Global Function.
Assists in the further build out of the DSPD/DSI Quality Management System including CAPA Management and Quality Metrics.
Head the West SOP Office which is charged with providing the management oversight for all Standard Operating Procedures (SOPs) and other related procedural documents in the West (US and Europe) Development division (Clinical, Regulatory, Pharmacovigilance, Clinical Supplies, etc). In this capacity, manage the creation, update, periodic review, retirement of procedural documents and deviations, and ensure that Daiichi Sankyo remains in a state of compliance with regulations.
Overseas the implementation of quality systems and GMP compliance programs for Investigational Medicinal Product (IMP), collaborates on cross-functional teams. This position also interacts with Quality Assurance sub-functional and cross-functional teams, as well as some vendors.
Manages the IMP release program and assures all suppliers and testing laboratories provide GMP compliant product release documentation. Participates as a cross-functional team member to provide product quality/GMP support and assures proper documentation of drug product release programs.
Manages and participates clinical GMP activities for IMP, and assures all activities are compliant with GMP and Daiichi Sankyo SOP requirements.
Manages and participates in the IMP recall activity and investigation program and assures proper documentation of recall and timely investigation.
Manages and participates in the supplier IMP GMP compliance audit program to assure that all DSPD contractors and vendors are audited at established frequencies.
Manages and participates in the investigation of production and analytical deviations associated with IMPs, and collaboration with other QA functions specifically GCP QA on any investigations on IMP related to clinical trial materials
Manages and implements notification, evaluation, disposition, reporting, implementation and tracking of proposed changes to IMPs. Assures that changes to IMPs are managed in accordance with GMP, IND and Daiichi Sankyo SOP requirements.
Manages and implements CAPA tracking and effectiveness check.
Proactive planning of GMP IMP activities: Participates in cross-functional meetings for any planning or supply forecast discussions and ensure proactive planning of GMP IMP activities as relevant.
Manages and participates CMO and supplier qualification program for DSPD IMP products. Implements and administers development and maintenance of GMP quality agreements for DSPD projects.
Cross-functional Team Participation: Participates as a cross-functional team member to provide product quality/GMP support for new product launch initiatives and technology transfer of existing products to new contract facilities
Education and Experience:
•BA/BS in chemistry, biology, microbiology, or allied sciences
•Five years’ experience in pharmaceutical operations including first-hand knowledge of drug manufacturing, packaging, quality assurance, regulatory compliance, quality control laboratory operations, and regulatory affairs
Manager of IMP-GMP
GDSI Quality Assurance