Associate Director, R&D QA in Basking Ridge, New Jersey at DSI

Date Posted: 10/8/2019

Job Snapshot

Job Description

Join a Legacy of Innovation 110 Years and Counting!

With over 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 hypertension and thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with a Competitive Advantage in Oncology,” Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.

Job Summary:

Provide leadership and direction based on assigned programs and in close collaboration with Head of QA R&D to ensure that the organization is in a perpetual state of compliance. Ensure strategic support is provided to Global Project Team (GPT) assignments and wherever necessary, takes the lead in ensuring procedural documents relevant to GPT as applicable, to relevant GxPs and captures the right level of regulatory importance. Partner and collaborate with key stakeholders (Clinical and PV teams) to ensure that key priority programs are adequately supported and that submission relevant activities are performed. Ensure end-to-end quality management through proactive compliance based on Clinical Development Plan (CDP). Liaise with the GxP audit function to ensure compliance of programs assigned and provides lessons learned from audits and inspections to program teams. Required to join study kick-off meetings. May support investigator meetings and CRO relevant meetings to provide quality overview/ training to relevant stakeholders. Provide guidance to development teams in quality and compliance decision making to drive sustainable and proactive quality. Provide leadership and guidance during the development and execution of Corrective and Preventive Actions (CAPAs). Coordinate and review CAPAs to audits to ensure adequate root-cause analysis and systemic solutions and is acceptable. Lead formal investigations of issues as they arise, ensuring timely escalation to line management if critical incidences are not resolved in due course. Identifies areas of continuous process improvement and engages QA teams as necessary as well as key stakeholders. Identify ways to continuously improve quality and compliance with regulations and company standards, policies and procedures through partnership with stakeholders and QA line functions. Represent QA in interactions with internal and external contacts and Health Authorities (HA), as appropriate. In collaboration with QA GxP team, ensure inspection readiness by preparing program teams for FDA, EU and key HA pre-approval and sponsor-monitor inspections; provide inspection management support and follow-up post inspections. Provide interpretation of regulations and company process standards, guidelines, policies and procedures to personnel specifically for assigned programs or for continuous improvement projects. Champion, develop and drive the implementation of study / program specific quality plan to ensure proactive management of quality.

Responsibilities:
  • Leadership/ Program oversight: Provide leadership, guidance and effective partnership to program teams to ensure proactive quality and implementation of quality at the onset of program design into execution. Ensure that protocols for assigned programs can be operationalized and address potential risks with key stakeholders. Ensure that quality is represented at key governance teams and takes the lead in instilling the right level of quality across programs assigned within the R&D organization. Support applicable GCP and CSPV quality and compliance standards/requirements and their implementation.
  • Quality Management and Continuous Improvement: Provide leadership and guidance during the development and execution of Corrective and Preventive Actions (CAPAs) for GCP and PV audits. In addition to audits, lead formal investigations of quality issues as they arise, ensuring timely escalation to line management of critical incidences and in collaboration with other QA line function (QA GxP audits, QA Standards and Procedures). Ensure adequate and effective lessons learned from audit, regulatory authority inspections and internal process deviations are delivered to program teams. Identify ways to continuously improve quality and compliance with regulations and company standards; policies and procedures through partnership with internal and external stakeholders; Development Line Functions and QA GxP groups. May be assigned to support with GRDSOP activities including the review and signing of deviations as appropriate. Other duties may be assigned.
  • Cross-functional and Global Team Participation: Closely cooperate with the Cancer Enterprise, Clinical Development for Continuous Improvement / Op Excellence and CSPV teams; participate and provide Quality and Compliance input for Process Excellence & Risk Management (PERM). Closely cooperate with the QA Standards and Procedures team, QA GxP Audit to ensure consistency of quality and compliance activities and effective communication. Ensure adequate liaison with legal and compliance with respect to third party relevant GPT and PV activities, provide QA input as necessary. Collaborate with Global QA teams in Japan and Germany as applicable to ensure relevant quality reports QQRs and or can be delivered and information presented in the QQRs are appropriately represented.
  • Customer Focused/ stakeholder engagement: Provide interpretation of GxP and Pharmacovigilance regulations and company process standards, guidelines, policies and procedures to relevant personnel. Champion the implementation of the study/program specific quality plan per assigned program. Ensure full understanding of business priorities and its applicability for adequate quality oversight. Ensure business objectives are closely aligned with quality deliverables.
  • Regulatory Inspections: Ensure inspection readiness by preparing clinical teams and CSPV 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.
Qualifications
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:
  • Required B.S. degree in scientific discipline or higher (MS, MA, MPH, MHA) in, health care, or related discipline; and/or background in Medical Health Profession (RN, Medical technologist, etc.)
  • Minimum seven/ten years pharmaceutical experience, at least 3 to 5 years of which are in the GxP/Pharmacovigilance environment, 5 or more years’ experience in leading/managing (Global) projects.
Ability to travel up to 20%

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.