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Sr Director, R&D QA in Bernards, NJ at DSI

Date Posted: 5/15/2019

Job Snapshot

Job Description

About Daiichi Sankyo Cancer Enterprise

The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA.

Job Summary:
Sets the vision for the quality strategy in close collaboration with the Cancer Enterprise, Clinical Development Organization, Quality Management function and all other cross function within Daiichi Sankyo.Provide oversight of early development (Translational clinical Oncology / CDx), and GMA activities; including formulation of tactics to optimize the outcomes of interactions with various key stakeholders. Oversees internal quality systems and processes to ensure compliance with applicable regulations and requirements; in collaboration with Line Functions or other business process owners, ensure that applicable clinical development, research related processes and quality standards are designed and implemented in line with health authority requirements.Drives the implementation of robust GxP (GCP,CSPV, PV) Quality Management System and Processes for all regulated areas where clinical trial activities are allocated and or executed. Facilitate through proactive and strong leadership; business process excellence to facilitate process simplification and improvement initiatives within the DSI/DS organization. Ability to share/ implement vision and strategy within the responsible line functions as well as globally.Directs globally Clinical processes for improving efficiency by optimizing processes necessary for continuous improvement at the regional and global levels. Together with Regional DSI Management teams, plans, supports conduct and reports Clinical Research and Pharmacovigilance quality assessments at regional level and supports GCP/CSPV/PV inspections across the organization and affiliates.
Leadership/Proactive Quality: Leads project initiatives within the organization. Serves as subject matter expert in Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) and act as a contact for internal and/or external stakeholders.
Regulatory Inspections Leadership and accountability: Together with Regional DSI Management teams, plans, supports conduct and reports Clinical Research and Pharmacovigilance quality assessments at regional level and supports GCP/CSPV/PV inspections across the organization and affiliates. Leads the oversight of all GCP, CSPV and PV quality and compliance activities across the organization and ensures strategic alignment for GCP-QA, and in close partnership with other GxP QA functions (GxP Audits, QSP QA team etc.,) ensure proactive communication to the relevant QA GxP teams. Oversight 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. Evaluates and monitors Health Authorities’ interpretation and application of their regulations and guidance, and changes in this interpretation / application over time.

Cross functional leadership and collaboration- Proactive Quality: Provide Quality Oversight for Health Authority Commitments, Critical Incidents including respective escalation process and the CAPA Management Process within the respective line functions in

Strategic Quality Leadership: Applicable GCP,CSPV and PV Quality standards/requirements and their implementation supported. Continuous improvement opportunities and system/process upgrades are identified and built into the annual objectives/Quality Plan cycle.


Education: Required Bachelor’s Degree or higher in Life Sciences, Pharmacy or Medicines. PhD in Life Sciences, Pharmacy or Medicines preferred.

10 or more years of experience in Quality and clinical development in the pharmaceutical industry with involvement in regulated clinical trial PV. Profound knowledge of drug development
Broad understanding of global expectations of Health Authorities
Thorough and extensive knowledge of ICH- GCP including FDA/PMDA/EU regulations, pharmacovigilance, new drug regulations, other key HA guidance’s, and current industry practice
Demonstrated experience of successfully leading an organization or projects of high impact
Demonstrated leadership and accomplishments in a global/matrix environment
Excellent verbal and written communication skills
Strong interpersonal skills with demonstrated ability to build collaborative relationships
Excellent problem solving and decision making skills. Skilled at conflict resolution / negotiation.
Strong project management skills
Considerable organization awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in global teams across different regions of the world.