Director, Clinical Quality Management

Basking Ridge, New Jersey
Jul 23, 2021
Pharm Country
Required Education
Bachelors Degree
Position Type
Full time
Join a Legacy of Innovation 110 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 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. Under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

The Director, Clinical Quality Management, is responsible for creating the strategic vision for and leading Clinical Operations activities required to ensure GCP inspection readiness and for tracking activities relating to GCP non-conformances/deviations and CAPAs. This position will conceptualize, create, and implement mechanisms for proactive planning and timely execution of these activities in partnership with Development Operations leadership, functional leads and QA personnel to include the Global Inspection Readiness Office (GIRO). This position is responsible for trending and analyzing GCP non-conformances/deviations and CAPAs to evaluate risk and identify continuous improvement activities across the Global Clinical Planning and Operations activities.

  • Vision and Strategy: Provides strategy for and leads the approach to Global Clinical Operations and Planning Inspection Readiness Activities aimed at delivering high quality, GCP compliant clinical studies, documentation, and submissions.
    Work with relevant Development Operations functional leaders, study team members and Quality Assurance, and external partners to develop a culture that supports GCP inspection readiness by proactively planning for and coordinating activities including:
    • Creation of the Project Inspection Readiness Team Plan (PIRT) at study start
    • Managing PIRT deliverables including activities relating to TMF readiness and inspection readiness of the sponsor, investigator sites, and vendors
    • Escalating any risks to the GIRO
    • Providing leadership and oversight during audit and inspections including coaching to Global Clinical Operations and Planning team members
    • Communicating best practices and lessons learned from inspection readiness activities and ensure they are incorporated across study teams and across the portfolio of studies.
  • GCP Compliance: Lead Corrective and Preventative Action (CAPA) Management Activities for Global Clinical Operations and Planning
    • Track planned audit and inspection activities impacting Global Clinical Operations and Planning function
    • Participate in audit/inspection re-cap/de-brief meetings conducted by Quality Assurance
    • Partner with relevant Clinical Operations functional leaders, study team members and Quality Assurance to:
    • Ensure thorough and complete Root Cause Analyses (RCA) are conducted
    • Review audit and inspection issues to ensure consistency of CAPA responses across studies.
    • Ensure clear action plans and pre-determined effectiveness checks are created as part of CAPA responses.
    • Track CAPA commitments and ensure resolution of within defined timelines.
    • Implement and manage escalation mechanisms to ensure appropriate resolution.
    • Lead performance of CAPA effectiveness checks as appropriate.
    • Report, analyze, interpret, and present CAPA insights to Global Clinical Operations and Planning Management as well as R&D Leadership to include oversight committees.
  • GCP Compliance: Determines the strategy for and leads implementation of Quality Control Checks for Global Clinical Operations and Planning Processes to ensure delivery of clinical trial activities with a high level of quality and compliance.
    • Perform independent quality control checks of Global Clinical Operation and Planning processes as agreed upon with Functional Leadership.
    • Identify high risk areas, provide assessment of process adherence, recommend required follow up actions and ensure their completion.
  • Learning and Development: Lead Clinical Quality Management Training and Education for Global Clinical Operations and Planning Function. Work with the Learning and Development team to:
    • Develop and provide training sessions based on findings during inspection preparedness and inspections.
    • Review Global Clinical Operations Planning training materials and recommend addition / updates based on audit and inspection learnings.
  • Process Improvement: Work with Development Initiative Team/Process Council and functional leaders to ensure changes necessitated by audit and inspection CAPAs / learnings are incorporated into Daiichi Sankyo procedures and inform prioritization of new process improvements.

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education Qualifications (from an accredited college or university)
Bachelor's Degree Bachelor’s Degree with minimum of 10 years’ experience in pharmaceutical or biotechnology clinical trial operations or clinical quality assurance required
Experience Qualifications
  • 10 or More Years •Understanding and experience with end-to-end clinical trial processes and functions including experience in one or more clinical trial operations functions / sub-functions •Significant knowledge / expertise relating to GCPs, relevant regulatory guidelines, and quality management principles and frameworks •Experience in global health authority inspections to include leadership in these inspections from a clinical operations perspective •Experience conducting root cause analysis and generating CAPAs •Strong project management skills and ability to influence other without direct authority •Excellent communication and collaboration skills including experience in leading projects/teams required

Ability to travel up to 5%

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.