Director, R&D QA

Location
Basking Ridge, New Jersey, United States
Posted
Oct 13, 2020
Ref
10522BR
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:
Lead the implementation of the quality strategy closely aligned with the business strategy within one or more Global Program Team(s) (GPT) within CE Development Franchises or Business Units. Provide strategic and proactive QA Leadership for respective GPTs and Clinical Programs in close alignment with the Head of R&D QA. Within assigned GPTs, facilitate the implementation of a risk based quality management process fully embedded through trial design, execution and submission including all vendor managed business set-ups with the objective of achieving the highest data quality standards, full adherence to patient's rights and well-being and in support of successful Health Authority inspections and approvals. Act as QA point person for all GxP matters for the Global Program Head and the Global Program Team. Provide operational QA leadership for the respective GPTs, including Quality Oversight for the Quality Plan execution, Health Authority Commitments, Critical Incidents including, respective escalation process and the CAPA Management Process for the respective business areas.

Responsibilities:
Facilitate the implementation of the quality strategy in close alignment with the GPT business strategy. Monitor and track implementation and break-down of the Quality Manual into an annual Quality Plan together with the supported GPTs including the quality risk assessments and inspection readiness components for the designated programs.

Support the Head of R&D QA with Quality Reviews of respective product profile to ensure appropriate management review of all quality and compliance related topics including the review of Key Quality Indicators (KQIs). Identify appropriate continuous improvement initiatives for quality and compliance related areas. Deputize for the Head of R&D QA at the Development Leadership teams as needed.

Interact with senior CE Franchise leadership teams to ensure Quality is consistently and proactively represented at program level and along the clinical trial process in support of a proactive quality risk management process. Interact with the audit function and the respective Data Management groups and respective CROs in order to ensure high data quality and proactive detection and resolution of issues.

Support strategic GPT Quality & Business initiatives, including the design and implementation of respective quality/compliance activities and affected changes, the activities for quality risk assessment for clinical programs and submission-critical trials, implementation of strategic process improvement.

Lead effective communications within the GPT, by interacting with other GxP QA functions (GMP/ IMP QA, Audit, Quality Standards and Procedures QA and in close collaboration with CAPA Manager.), on GxP topics/issues impacting the respective clinical programs.

Help to ensure in collaboration with CDO (Clinical Development Operations)/ PERM/ QM or other business process owners that applicable clinical development processes and quality standards which are in line with worldwide HA requirements are implemented. Help to establish in-built controls in relevant process steps to ensure adherence to regulatory compliance.

Monitor effectiveness of implementation of applicable clinical development processes through KQIs in collaboration with business process owners to demonstrate that processes are in control and ensure required compliance levels. Implement and lead the process to regularly review and assess KQIs at the respective GPTs, and prepare respective management documentation for the QA Head for review at the Quality Leadership level and Development Leadership level/ governance teams. Ensure that potential gaps and risks are addressed and opportunities for continuous improvement identified.

Ensure adequate and timely escalation of incidents/issues within GPTs and QA.

In collaboration with GxP CAPA manager provide Quality oversight for deviations/incidents & investigations and ensure that adequate CAPAs are defined, implemented and their closure tracked.

Ensure that proper Quality oversight is implemented within the GPTs for 3rd par-ties/vendors/outsourced activities.

Provide oversight over the implementation of CAPA effectiveness checks.

Ensure continued submission and inspection readiness for the respective GPTs and related submissions. Facilitate respective regulatory inspection preparation, management and follow-up in collaboration with business functions. Support local inspections with adequate systems and process support.

Support the Global and Regional Clinical Operations Leads and their teams with Quality input and oversight for the execution of clinical trials under their responsibility.

Lead Lessons learned information flow at the GPT/Clinical Operations level based on audits, inspections, regulatory intelligence, effectiveness checks and process improvement.

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

Education/Experience:
  • Required Bachelor's degree in Life Sciences, Pharmacy or Medicines. Preferably Advanced Degree or PhD in Life Sciences, Pharmacy or Medicines.
  • At least 7-10 years of involvement in regulated activities, clinical development and QA (preferably) leader- ship positions; broad understanding of global expectations of Health Authorities in the area of Clinical Development; profound understanding of the science of product development
  • 8 or more years of demonstrated accomplishments in a global/matrix environment in the pharmaceutical industry.
  • 5 or more years' experience in leading/managing Global projects.
  • Ability to effectively interact with and present to senior management at all levels, as well as to external audiences and inspectors.
  • Considerable organization awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross- functionally and in global teams.
  • Fluency in English (oral and written)
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.
Job Title
Director, R&D QA

City
Basking Ridge

Functional Area
Quality Assurance

State
New Jersey