Associate Director, R&D Quality in Basking Ridge, NJ at DSI

Date Posted: 10/25/2020

Job Snapshot

Job Description

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:

Support CE Franchise Development Project Teams and GCP with adequate quality and compliance guidance.
-Provide quality and compliance guidance for process deviations and implementation of corrective and preventive actions; monitor their status and timely closure in close collaboration with CAPA Manager.
-Ensure adequate risk mitigation strategy in place for assign programs. May take the lead in preparing clinical teams for regulatory inspections. Collaborate with other QA functions to ensure proactive quality across development programs.

Responsibilities:

Guide development teams in quality and compliance decision making to drive sustainable quality and compliance excellence

Provide leadership and guidance during the development and execution of corrective and preventive actions (CAPA)

Supports in the coordination and the review of CAPAs to audits to ensure adequate root cause analysis and systemic solutions.

Provide leadership and guidance during the development and execution of corrective and preventive actions (CAPA)

Supports in the coordination and the review of CAPAs to audits to ensure adequate root cause analysis and systemic solutions.

Ensure inspection readiness by preparing clinical teams for FDA/EU/key HA pre-approval and sponsor-monitor inspections; provide inspection management support and follow-up post inspection

Ensure that compliance commitments are fulfilled on time

Provide interpretation of GCP regulations and company process standards, guidelines, policies and procedures to personnel

Drive the implementation of the annual Quality Plan into Franchise Quality expectations; identify relevant areas to be addressed in future Quality Plans.

Closely cooperate with the CE Franchise teams and Dev Operations teams for Continuous Improvement/Op Excellence groups; participate and provide Quality and Compliance input for process improvement teams (Process Excellence and Standards)

Closely cooperate with the Quality and Standards QA team, Auditing, to ensure consistency of quality and compliance activities and effective communication

Collaborate with Global QA teams in Tokyo to ensure relevant quality reports QQRs and or assigned by manager can be delivered in a timely manner.

Perform additional duties as assigned relevant to key transformation and quality improvements initiatives.

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

Education/Experience:

Required Bachelor or higher degree in Life Sciences, Pharmacy or Nursing.

Minimum of 7 years of Quality Assurance experience and involvement in regulated activities; broad under- standing of global expectations of Health Authorities in the management of clinical trials.

Thorough and extensive knowledge of international GCP regulations including FDA/EU GCP, ICH, pharmacovigilance, new drug regulations, other key HA guidance’s, and current industry practice

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.