Associate Director, QA GxP Audits

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.

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

Under the direction of Head of QA GxP Audits, supports and ensures all assigned audits are managed, audit reports issued as per pre-defined timelines and mitigation and remediation activities related to the GxP audits are addressed throughout the audit cycle.  Contributes to identifying which programs require prioritization for audits based on applied risk methodology. This position interacts across the GxPs and is pivotal in ensuring that the organization is in a perpetual state of compliance.  May be tasked to work with integrity and compliance in assessing or addressing internal corporate audit needs for the organization in 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. Accountable for ensuring lessons learned from audits and inspections are provided to stakeholders and throughout QA team to ensure end-to-end organizational awareness and continuous improvement. General awareness and understanding of systems and tools used for clinical trials and ability to assess processes and ensure its purpose (limited to validation activities). Deploys inspection readiness programs are in place and supports regulatory inspections in collaboration with other QA functions and stakeholders.  In conjunction with QA Standards and Procedures, participates in continuous improvement initiatives stemming from lessons learned from audits and that may involve authoring procedural documents or enhancements. Ensures adequate audit strategy across boundaries and may be tasked to support audit activities within DS Group and/or affiliates.  Accountable for engineering relevant training activities to support lessons learned and ensure regulatory understanding and impact stemming from audits and inspections.  Ensure adequate issue escalation and risks are communicated to management and QA teams as aligned with QA Audit Planner and Risk Management.  Ability to conduct activities independently and applies systemic approach and strategy to address any organizational risks identified through audits.

Responsibilities

• Execute all aspects of a fully functional GCP-QA audit program against the audit strategy as assigned with focus 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 and consultants.
• Deploy the service provider Audit Program to assure that all GxP service providers and CROs are appropriately qualified.
• Lead and execute for all aspects of GCP/GCLP regulatory inspections (internal) at the GQA and DS facility in Baskin Ridge, NJ, and investigator sites, CROs this includes preparations, conduct, coordinating responses to inspections and ensure supporting documentation, tracking and verification of CAPA commitment implementation.
• Collaborate 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 vendors/CROs, investigator sites, bioanalytical labs, internal systems, etc.
• Identify and lead process improvement initiatives and ensures prompt communication to QA R&D team and other business functions.
• Interpret relevant regulations and apply them to practical clinical research and development programs.
• May support SOP creation/ updates relevant to the audit scope that adheres to regulatory guidance.
• May participate in lessons learned training for audit outcomes with other QA function and business stakeholders
• Lead metrics development and the implementation of corrective and preventive actions, tracking of audits and inspections including Quarterly Quality Reports for distribution to the Global QA group and stakeholders.

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

Education Qualifications (from an accredited college or university)

• 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 7-10 years pharmaceutical experience, at least 5 of which are in the GCP/PV audits
• Ability to be present at the Basking Ridge office (excluding the company approved telecommute days) for engaging in team interaction, building team dynamics & cohesivity and support during GCP sponsor inspections

Experience Qualifications

• 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. preferred
• First-hand knowledge of drug development as a CRA, GCP Compliance Professional or other related function. preferred
• Experience of direct dealings with the FDA, MHRA and other European regulatory agencies. preferred
• Direct dealings with regulatory agencies. preferred
• Strong appreciation of the impact of regulatory bodies on drug development. preferred
• International experience is a plus; but at minimum, experiences working with diverse cultures and employees. preferred
• Experience working with pharmaceutical development studies. preferred

Travel

• Ability to travel up to 30% In-house office position that may require travel (global).

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.

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.