Associate Director eCompliance in Basking Ridge, New Jersey at DSI

Date Posted: 11/27/2019

Job Snapshot

Job 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:

Support 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 Daiichi Sankyo enterprise.

In coordination with Quality leadership, this role will be responsible IT GxP compliance harmonization. Support and provide technical 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. Determine effective and efficient risk-based approach for validation and qualification of IT services.

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.

Support business process excellence for process simplification and harmonization initiatives across the global organization. Ability to implement vision and strategy within the responsible line functions as well as cross-divisionally.

Support overall quality team’s deliverables and is implement QA plans and strategies for computerized systems, processes, procedures including Data Integrity philosophy. Lead and/or collaborate with operational teams and ensure that standard processes are followed pertinent to project specifications. Manage data analytics and 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:
  • Support and manage the implementation 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.)
  • With guidance from leadership, enhance and implement Data integrity global strategy and champion educational materials, quality culture change initiatives, campaign across the organization.
  • Identify and support the implementation of monthly quality reports to QA leadership pertinent to e-compliance and all other activities as assigned.
  • Manage the implementation of cross functional / divisional quality strategy in close collaboration with the business strategy on IT harmonization in collaboration with Senior Leadership.
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.
  • Ensure identified computerized systems risks are duly addressed in collaboration with cross functional/ IT. Actively identifies and leads continuous improvement projects relevant to strengthen the technology advancement of the organization.
  • Ensure QA is represented in IT/ CSV governance and or 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, driven by continual improvement, consistently applied across clinical development and fully in line with global health authority requirements and DSI/ DSG Standards.
Cross-functional and Global Team Participation:
  • Manage and support 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 & functional units (eg. Biostats and Data Management, Clinical, Regulatory, PV; etc) ensure that operational related gaps in e-compliance QA and / or IT related activities are applied 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.
  • Support innovative technologies used in clinical trial studies as well as the transformation of existing clinical trial processes
  • Supports DSG/DSI-external, industry leading interest groups/forums including but not limited to DIA and eClinical forum with the objective to influence HA guidelines and expectations.
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.
Qualifications
Successful 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 7- 10 years of experience in Quality, IT compliance and/or clinical development in the pharmaceutical industry with involvement in clinical trial and/or technical QA activities (i.e., Clinical, Data management etc). specifically, IT Compliance
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.