Associate Director, QA GxP Audits in Basking Ridge, New Jersey at DSI

Date Posted: 11/6/2019

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:
  • Responsible for managing assigned aspects of a fully functional GxP-QA audit program for DSI Phase I through IV studies of clinical development and supporting Discovery phase QA activity where necessary.
  • To manage the Service Provider and Systems and process Audit Program to assure that all acceptable state of compliance
  • Responsible for supporting all aspects of GCP regulatory inspections at investigator sites, CROs and sponsor facility during preparations, conduct, coordinating responses to inspections, and to ensure supporting documentation, tracking and verification of CAPA commitment implementation.
  • To assure that all studies performed by DSI and DSJ are in compliance with GCP/GLP requirements and can withstand scrutiny from regulators in all countries where we study and register our products.
  • To manage metrics and the implementation tracking of corrective and preventive actions in follow-up to audits and inspections.
  • To work with the Japan, EU, and other DS QA groups in developing and implementing QA GCP/GLP objectives and audit schedules to include development related audits of CROs, investigator sites, bioanalytical labs, etc.
  • Member of Global QA - work with the Global QA group and to participate and represent GQA in Global QA group leading joint audits and global SOP development.
  • To assure that Daiichi Sankyo QA is a full partner in development activities and that world class development standards are applied wherever we do business.
  • To liaise and consult with Early and Late Strategy, development teams, Pharmacovigilance, Operational and Technical Services and others to ensure local and global conformance with regulatory requirements, good clinical practice, internal standards, and to provide pro-active integration of quality and process improvement.
  • To interpret relevant regulations and apply them to practical clinical development programs.
  • To assure compliance to all regulatory requirements for the protection of human subjects.
  • To ensure fraud resilient data collection and apply systematic approaches to detect and assess potential fraud.
  • To create specific Quality Assurance SOPs and policies that adheres to regulatory guidance.
Responsibilities:
  • Responsible for managing all aspects of a fully functional GCP-QA audit program that focuses on the Phase I to IV studies of clinical development. Providing assurance that GxP QA’s regulatory, documentation and record-keeping requirements are met internally and externally at CROs, and investigator sites. This includes ongoing communication with global DS QA locations, and QA Outsourcing Providers, Consultants.
  • To develop and manage Service Provider Audit Program to assure that all service providers are appropriately qualified.
  • Responsible for all aspects of GCP/GCLP regulatory inspections (internal) at the GQA and DS facility in Baskin Ridge, NJ, this includes preparations, conduct, coordinating responses to inspections and follow-up with implementation checks of commitments.
  • To work with the Japan, EU and other DS QA groups in developing and implementing GQA GCP/GCLP objectives and audit schedules to include development related audits of CROs, investigator sites, bioanalytical labs, etc.
  • Member of Global QA - work with the Global QA group in participating and representing GQA group in Global QA group leading joint audits and global SOP development.
  • Interpret relevant regulations and apply them to practical clinical research and development programs. This is done in part by creating specific Quality Assurance SOPs and policies that adhere to regulatory guidance.
  • To manage metrics, corrective and preventive action tracking of audits and inspections including Quarterly Quality Reports for distribution to the Global QA group.
Qualifications
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:
  • Qualified candidates must have a Bachelor’s degree from an accredited college or university; Minimum of a B.S. degree in a scientific, health care or related discipline and/or background in Medical health Profession (RN, Medical technologist, etc.)
  • Substantial Quality Assurance experience with a world class quality organization in the Pharmaceutical/CRO industry. In particular, working as an internal QA consultant to development teams.
  • First-hand knowledge of drug development as a CRA, GCP Compliance Professional or other related function.
  • Experience of direct dealings with the MHRA and other European regulatory agencies.
  • Direct dealings with regulatory agencies.
  • Strong appreciation of the impact of regulatory bodies on drug development.
  • International experience is a plus; but at minimum, experiences working with diverse cultures and employees.
  • Experience working with pharmaceutical development studies.
  • Enhances performance by doing things that are unique and takes well-calculated risks in decision making.
  • Adapts easily to new circumstances and is flexible in a work environment that makes frequent changes in its demands.
  • Demonstrates respect for and capitalizes on cultural diversity and seeks out perspectives when developing strategies, both international and domestic.
  • The ability to motivate and influence employees at all Daiichi Sankyo levels, as well as at CROs and investigator sites.
  • Develop positive and constructive relationships both inside and outside of Daiichi Sankyo (e.g., regulatory agencies, CROs, domestic and international Daiichi Sankyo sites).
  • Create a commitment to a high level of quality within our operation and at our CROs and investigator sites.
  • Maintain current knowledge of GCP regulatory issues and assure our related business needs are met.
  • To manage budgetary and cost issues within the quality function.
In-house office position that may require travel (global) 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.