Senior Director, QA CDx in Basking Ridge, NJ at DSI

Date Posted: 1/7/2021

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. 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.

Summary
  • A strategic thinker, with the capability to interact cross divisional and manage day-to day- operations of the group through leadership and effective interaction/influential skills.
  • Provide QA leadership, develop and implement the quality strategy and work in partnership with stakeholders to support Cancer Enterprise, R&D, QCSP, in the delivery of companion diagnostic (CDx) projects within Daiichi Sankyo's early and late state development portfolio. May interact with other business units as necessary.
  • Ability to positively impact company/ BU culture and demonstrate flexibility in fast paced environment; is committed to the values of integrity, accountability, transparency, leadership rigor and drive necessary for the success of the R&D portfolio.
  • Ensure the vision is in place to build the talent pipeline(recruitment) and ensure succession plans are in place and promote the values of integrity, accountability, transparency necessary to drive change in fast pace, changing organization.
Responsibilities
  • Ensure effective cross functional collaboration and operational excellence to champion a synergistic approach to quality issues and resolution. Partner with QCP, R&D, Translational Oncology and QA Quality Standards and Procedures to develop fit for purpose quality systems that supports CDx and Precision medicine. Ensure adequate alignment with overall Daichi Sankyo quality policies and support effective collaboration with the relevant line functions and BUs. Ensure adequate and timely escalation of incidences/issues within business senior management and QA functions. Further ensure proper quality oversight and escalation of issues / incidences specifically as it relates to the support functions impacting the QA teams such as 3rd parties/vendors/outsourced activities. (ISO13485, MDSAP/CE, CFR 820, GMP, etc.).Develops, leads and delivers QA strategy and governance in collaboration with R&D and QCP prioritization. Ensures adequate execution and quality oversight of programs necessary for global registration and commercialization of CDx.
  • Develop a QA structure that could support CDx activities at the global level and ensure proactive representation of QA at strategic project teams and ensure proper cross-functional learnings and interactions from CDx assay development through CDx approval and launch.
  • Support through open and effective communication and business partnering the cross-functional implementation of the Vision and Mission of Global QA. Drive a culture of solution oriented and evidence-based mind-set with openness for innovative ways of working and new technologies. Implementing strategic and tactical plans to drive sustainable improvement. Ability to exercise influence at the senior leadership and/ or executive level wherever CDx programs impacting Oncology are being discussed.
  • Provides QA leadership/guidance as deemed necessary for CDx assay development, validation, patient enrollment, sample analysis activities, and collection and/or review of regulatory documents. Supports Regulatory Affairs in providing quality content and review of documents supporting CDx submissions to Health authorities globally. Ensure PMA readiness by facilitating, preparation, management and follow-up in collaboration with business functions. Lead and/ or support local and global inspections with adequate systems and process. Lead and/ or support compilation, articulation of corrective actions, facilitation of metrics, and ensure adequate oversight of resolution of quality issues.
  • Liaise effectively with Head of CDx Function to ensure end to end oversight of operational and technical activities impacting teams are assessed, reviewed and issues mitigated as appropriate. May Support the implementation of an enhanced self-assessment/self-inspection process. May provide contributions to portfolio including supporting assessment of BD opportunities as necessary.
  • Collaborate with GMP QA and RDPV QA audit function to ensure an established and well-defined risk- based audit plans, quality assessments and deliverables are in place for Precision/CDx Oncology function. Build a comprehensive audit program from planning to execution to assure proper diligence. Liaise effectively with R&D QA teams in Japan/ APAC, Americas and EU to ensure adequate support and oversight of global CDx programs meet GxP requirements and that processes consistently applied support high quality clinical trials and data.
  • Serve as a key contributor on several leadership teams and governance committees to provide quality overview, metrics, trends, impacting the business portfolio: Precision Medicine/CDx Committe, External Alliance Committee, Quality leadership team, and Develop/chair or co-lead quality council as necessary.
  • In collaboration with Global QA strategy and Operations may be tasked to Manage the relevant budget and headcount including: Monthly review with Finance and updates for QA global cost centers and tracking against targets, Monitoring any external expenses, Managing expenses for 3rd party contractors and consultants, as applicable. Assuring compliance to FTE targets through direct interactions with HR and Finance.
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education (from an accredited college or university)
  • Bachelor's Degree Life Sciences required
  • Master's Degree Life Sciences, Pharmacy preferred
  • PhD Life, Science, Pharmacy Medicines preferred
Experience
  • 10+ years of involvement in GxP regulated activities, and QA leadership positions broad understanding of global expectation of Health Authorities in the GxP area
  • 10+ years of demonstrated leadership and accomplishments in a global matrix environment in the Pharmaceutical industry. 10+ years of people management experience in a matrix environment.
  • Strong management, interpersonal, communication, negotiation, problem-solving skills, and project management skills.
  • Considerable organization awareness, including significant experience working cross-functionally and in global teams.
  • Strong industry network in clinical development, manufacturing, regulatory and device required
Travel
Ability to travel up to 30% Domestic and International Travels may be required

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.