Associate Director, Clinical Quality Management

Location
Basking Ridge, New Jersey
Posted
Jul 23, 2021
Ref
10683BR
Hotbed
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. In addition to a strong portfolio of medicines for cardiovascular diseases, 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.

Job Summary:

The Associate Director, Clinical Quality Management, is responsible for identifying and coordinating Clinical Operations activities required to ensure GCP inspection readiness and for tracking activities relating to GCP non-conformances/deviations and CAPAs. This position will create and implement mechanisms for proactive planning and timely execution of these activities in partnership with Development Operations functional leads and QA personnel to include the Global Inspection Readiness Office (GIRO).

Responsibilities:

Lead Global Clinical Operations and Planning Inspection Readiness Activities

Work with relevant Development Operations functional leaders, study team members and Quality Assurance,
and external partners to proactively plan for and coordinate activities that ensure GCP inspection readiness
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.

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.

Lead Quality Control Checks for Global Clinical Operations and Planning Processes
· 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.

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.

Work with Development Initiative Team/Process Council7- 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/Experience:

Bachelor’s Degree with minimum of 7-10 years’ experience in pharmaceutical or biotechnology clinical trial operations or clinical quality assurance

Understanding and experience with end-to-end clinical trial processes and functions including experience in one or more clinical trial operations functions / subfunctions
•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

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.