Clinical Quality Management Lead, Inspection Readiness Specialist
2 weeks ago
Daiichi Sankyo Group is committed to the development and provision of groundbreaking pharmaceutical solutions aimed at enhancing healthcare standards and addressing diverse, unmet medical needs globally through our exceptional scientific and technological capabilities.
With over a century of scientific knowledge and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 global employees leverage a rich history of innovation and a strong pipeline of promising new therapies to benefit patients.
In alignment with the Group's 2025 Vision to establish itself as a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily dedicated to delivering novel treatments in oncology, alongside other research areas focused on rare diseases and immune disorders.
SummaryThe Clinical Quality Management (CQM) Lead, Inspection Readiness Specialist (IRS) plays a pivotal role in supporting Clinical Inspection Readiness (IR) and pre-approval inspection preparation activities for global clinical operations. This position represents the GCO-CQM inspection readiness within the Clinical Team, the inspection preparation team, and cross-functional clinical improvement project working groups.
This role is expected to consistently facilitate the process of gathering, analyzing, and disseminating best practices and lessons learned.
The CQM IRS will collaborate with R&D Quality Assurance (R&D QA) and operational functions to pinpoint areas for enhancement based on audits, IR/preparation activities, inspection outcomes, and investigational panels, while determining the appropriate next steps for strategic process updates and/or information dissemination.
Responsibilities:
GCP Compliance:
Establish seamless partnerships within GCO and non-GCO functions to ensure that Study Management Teams (SMTs) adhere to necessary ICH/GCP-relevant regulatory requirements and global, departmental, and geographical Standard Operating Procedures (SOPs), policies, and guidelines.
Assist the inspection preparation team before, during, and after regulatory agency sponsor inspections to ensure that GCO/clinical teams are adequately prepared and trained, and that study documentation is quality controlled and accessible.
Post-inspection, audit, quality review, investigational panel, or other identified sources, gather, analyze, prepare, and present lessons learned/best practices to the GCO platform and other key stakeholders.
Strategic Planning and Oversight:
Support strategies to collaborate with GCO and cross-functional departments to cultivate 'inspection readiness', identify and mitigate clinical quality risks during study initiation, conduct, and closure/study reporting.
Ensure that administrative documents (CVs, JDs, etc.) for GCO departments required for inspection readiness are maintained, updated, and readily accessible.
Process Improvement:
Assist in the formulation of Inspection Readiness Plans and metrics with respective functional team leaders and applicable Co-Development Partners and Contract Research Organizations (CROs).
Metrics and Collaboration Opportunities:
Support clinical teams in generating metrics and dashboards for the status of inspection readiness reporting elements to management on a monthly basis or as required.
Qualifications:
Successful candidates will be able to meet the qualifications below with or without reasonable accommodation.
Education Qualifications:
Bachelor's Degree with a minimum of 3-5 years of experience in the pharmaceutical or biotechnology sectors, specifically in clinical trial operations or clinical quality assurance.
Expertise in Clinical Operations from Phase 1 to 4 Trial Execution.
Experience in oncology trial execution is preferred.
Demonstrated critical thinking and problem-solving abilities.
A quality-focused mindset and prior quality experience are preferred.
Strong collaboration, interpersonal, oral, and written communication skills.
Robust project management skills and the ability to influence others without direct authority.
Experience with SOPs and working in a regulated environment is preferred.
Understanding and experience with end-to-end clinical trial processes and functions, including experience in one or more clinical trial operations functions/sub-functions (Data Management, Biostatistics, Clinical Science) is preferred.
Travel:
Willingness to travel up to 5% for team/global meetings, conferences, and to support inspections.
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.
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