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10006BRAuto req ID:10006BRJob Description:Join a Legacy of Innovation 110 Years and Counting!With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with a Competitive Advantage in Oncology,” Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.Job Summary:Lead enterprise cross- functional QA & R&D teams with data driven solutions to support the global R&D organization for compliance of related GxP electronic systems. Design fit for purpose processes and provide operational and technical oversight of GxP IT systems cross divisionally, regionally and within the global DSI enterprise. In coordination with Quality leadership, this role will be responsible for the direction of IT GxP compliance harmonization. Support and provide leadership in interacting and collaborating with cross functional teams to manage the IT QA portfolio and reporting of GxP projects and Computer Systems Validation requirements.In collaboration with QA leadership, determine/support relevant audit targets for GxP computerized systems to support GxP compliance. Act as a change agent with the ability to influence the organization by creating, managing and implementing, regulatory driven computerized systems platform effectively and efficiently.Ability to facilitate through proactive and strong leadership; business process excellence to support process simplification and harmonization initiatives across the global organization. Ability to share/ implement vision and strategy within the responsible line functions as well as cross-divisionally.Responsible for overall quality team’s deliverables and is responsible to establish and execute the QA plans and strategy for computerized systems, processes, procedures including implementation of Data Integrity philosophy. Lead and/or collaborate with operational teams and ensure that standard processes are followed pertinent to project specifications. Deploy data analytics and is accountable to ensure that data investigations stemming from systems used for data collection are properly investigated and that technology related audits are performed in collaborations with the audit function and other business teams (i.e., IT, compliance, GxP audit function)Responsibilities:Leadership/ Program oversight:
Possess the technical know-how to provide QA Leadership of clinical development systems (e.g., data management, stat programming, digital technologies, clinical operations (i.e., vendor oversight, clinical training module management, and centralized clinical operations processes as it impacts the global development organization.)
Defines and leads the Data integrity global strategy and champions educational materials, quality culture change initiatives, campaign across the organization.
Oversight of and leadership to ensure QA regulatory input and position is in-stilled related to (VLM, business continuity, change control, disaster recovery, Incidence report process etc)
Develop and provide monthly quality reports to QA leadership (direct management) pertinent to e-compliance and all other activities
Ensure Leadership oversight of the following key global systems (ARGUS, VEEVA, RIMS, RAVE etc) and ensure business deliverables and QA oversight is in place for locally driven systems to ensure proper regulatory application.
Quality Management and Continuous Improvement:
Ensure effective collaboration with IT to ensure that IT systems are developed and managed in accordance with business and regulatory expectations.
Ensures that system inventory management is in place & is monitored
Ensure processes are in place for review/collaboration of systems for affiliate companies & that data integrity is duly assessed.
Ensure identified computerized systems risks are duly addressed in collaboration with cross functional/ IT. Actively identifies & leads continuous improvement projects relevant to strengthen technology advancement
Ensure QA is represented in IT/ CSV governance and Leadership teams such that quality related issues can be duly addressed
Ensures strong GxP (GLP, GMP, GCP) leadership knowledge of IT Systems and GxP technologies (i.e., biomarker, devices, diagnostics, imaging) and ensure regulatory applicability and consistent data integrity is applied
Foster a quality culture and a Quality Mindset where a robust Quality Management System related to IT systems, is jointly maintained with all business process owners, applied across clinical development and fully in line
Cross-functional and Global Team Participation:
Guides and supports project teams with relevant compliance assessments, requirements and test scripts, validation plans/ protocols and reports.
Participate and is an active QA member for R&D unit at study design and planning to ensure requirements for computerized systems specific to data management are duly addressed properly (i.e., studies indicating study blind process, biomarker sample collections, data base lock / unlock, EDC system queries, etc.,)
In close collaboration with QA and functional units (eg. Biostats and Data Management, Clinical, Regulatory, Pharmacovigilance; etc) ensure that operational related gaps in e-compliance QA and / or IT related activities are applied rigorously throughout the development/ manufacturing activities.
Customer Focused/ stakeholder engagement:
Provides quality e-compliance support during deployment of global solutions and / or systems and ensure global standards / SOPs are in place, effective, meet regulatory expectations and can be implemented.
Identify and support strategic quality and business initiatives including appropriate remediation programs, quality/compliance activities and affected changes.
Regulatory Inspections:
Support of regulatory inspection preparation, management and follow-up in collaboration with business functions, and support local inspections specifically when IT-systems and / or global clinical operations are in scope.
QualificationsSuccessful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education/Experience:
Degree or Masters in Life Sciences, Engineering or Sciences
At least 12years of experience in Quality, IT compliance and/or clinical development in the pharmaceutical industry with involvement in regulated clinical trial and / or technical QA activities (i.e., Clinical, Data management etc). specifically, IT Compliance
Ability to travel up to 20%Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.Job Title:Director eComplianceCity:Basking RidgeFunctional Area:Quality AssuranceState:New Jersey
