Daiichi Sankyo US · 18 hours ago
Associate Director PV Quality, Americas
Basking Ridge, NJ
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
$151K/yr - $226K/yr
7+ years expDaiichi Sankyo US is dedicated to improving lives through innovative medicines and is seeking an Associate Director PV Quality. This role involves implementing quality strategies, providing QA leadership, and ensuring compliance within the CSPV function, while also participating in regulatory inspections and audits.
Health CareTherapeuticsWellness
Responsibilities
Facilitate the implementation of the quality strategy in close alignment with the CSPV business strategy
Monitor and track implementation and break-down of the Quality Manual into an annual Quality Plan together with the supported CSPV teams, including the quality risk assessments and inspection readiness components for the designated programs
Ensure proactive representation of Quality professionals at strategic non-project team and at CSPV strategic discussions
Participate in the development and/or enhancement of CSPV Strategy and PV/GxP QA business processes, procedures, and best practices
Support the Head of PV QA, Americas with Quality Reviews of respective product profile to ensure appropriate management review of all quality and compliance related topics including the review of Key Quality Indicators (KQIs)
Interact with senior CSPV leadership teams to ensure Quality is consistently and proactively represented at program level and along the clinical trial process in support of a proactive quality risk management process
Interact with the audit function
The respective CSPV groups and respective CROs, Partners and Affiliates in order to ensure high data quality and proactive detection and resolution of issues
Actively participate in special assignments on various project teams and work streams as determined by QA management
Effectively communicate with CSPV, by interacting with other GxP QA functions (R&D Quality, GMP/ IMP QA, Audit, Quality Standards and Procedures QA and in close collaboration with CAPA Manager.), on CSPV topics/issues impacting the respective Pharmacovigilance operations and safety activities
Collaborate with CSPV and Global PV Quality on quality review of PV and REMS documents, including SOPs, Pharmacovigilance Site Master File (PSMF) audit content, and REMS material
Help to ensure in collaboration with CSPV or other business process owners that applicable CSPV processes and quality standards which are in line with worldwide HA requirements are implemented
Help to establish in built controls in relevant process steps to ensure adherence to regulatory compliance
Keep abreast of changes in regulations and enforcement actions and make recommendations for changes to Daiichi Sankyo’s policies and practices to maintain proactive compliance
Ensure adequate and timely escalation of incidents/issues within CSPV and QA
Lead formal investigations of issues as they arise, ensuring timely escalation to line management if critical observations are not resolved in due course
In collaboration with GxP Quality Systems and Compliance provide Quality oversight for deviations/incidents & investigations and ensure that adequate CAPAs are defined, implemented and their closure tracked
Provide leadership and guidance during the development and execution of corrective and preventive actions (CAPA)
Coordinate and review CAPAs to audits to ensure adequate root cause analysis and systemic solutions
Ensure that proper Quality oversight is implemented for 3rd parties/vendors/outsourced activities
In collaboration with CSPV develop Lessons learned information flow at the CSPV operational level based on audits, inspections, regulatory intelligence, effectiveness checks and process improvement
Ensure continued submission and inspection readiness for the respective CSPV team and related submissions
Facilitate respective regulatory inspection preparation, management and follow-up in collaboration with CSPV
Support local inspections with adequate systems and process support
Qualification
Required
Bachelor's Degree in Life Sciences, Pharmacy or Medicines required
7 or more years of involvement in regulated activities, clinical development, PV and QA (preferably) or equivalent experience required
Must have a broad understanding of global expectations of Health Authorities in the conduct of clinical trials required
Proven ability understanding the pharmaceutical product development process required
Must have extensive knowledge of international GvP regulations including FDA, EMA and ICH required
Ability to travel up to 20% of the time required
Preferred
Master's Degree or other advanced degree preferred
GCP regulations preferred
Company
Daiichi Sankyo US
Daiichi Sankyo US is a pharmaceutical company delivering innovative research, solutions, and treatments to improve health.
10001+ employees
H1B Sponsorship
Daiichi Sankyo US has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (32)
2024 (25)
2023 (19)
2022 (12)
2021 (7)
2020 (6)
Funding
Current Stage
Late StageLeadership Team
Ken Keller
Chairman of the Board, President and CEO and Head of the Global Oncology Business Unit
Christopher Geloso
Senior Region Business Director - ADC Oncology at Daiichi Sankyo, Inc.
Recent News
2025-06-01
2025-02-18
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