Manager, QA GxP Audits

Location
Basking Ridge, NJ, United States
Posted
Nov 05, 2020
Ref
10510BR
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:

Under the direction of Head of Global QA GxP Audits ensures the following:
  • Assigned GCP and PV audits are managed and conduct audit related activities from preparation to writing and distribution of reports issued as per pre-defined timelines
  • Close collaboration with CAPA and Deviation Manager, to verify adequacy of CAPA plans stemming from audits and inspections. Play a major role to establish appropriate implementation and effectiveness checks Ensure CAPAs and or trends included in respective Monthly and Quarterly Quality Reports are correct, adequate and provides the accurate management awareness.
  • Prioritization and scheduling for audits in the Global Audit Master Schedule (GAMS) using feasibility assessments (remote audits), GxP Risk Assessment questionnaires, in-house risk assessment techniques and other pertinent tools and strategies available to the audit team.
  • Lessons learned from audits and inspections are provided to stakeholders and throughout QA team to ensure end-to-end organizational awareness and continuous improvement. May participate in continuous improvement initiatives stemming from these lessons learned from audits and that may involve authoring procedural documents or enhancements.
  • Effective collaboration with stakeholders and QA cross-functional teams (Global R&D QA, R&D Audits, PV-Audits, DSE & DSBr QA, QA Standards and Procedures, QA Strategy and Operations, PERM etc.)
  • Support to the QA GxP Audits team that leads in preparing and supporting Investigator Site Inspections and larger QA team actively in all other inspection support activities such as CRO, Service Provider and GCP/PV inspections
  • Strong collaboration with QA Standards and Procedures and proactively identifies areas in need of process improvement initiatives and ensures prompt communication to R&D QA team.
  • Value added interaction across GxPs for developing a robust culture of quality
Responsibilities:
  • Relevant experience in conducting hands on GCP and PV audits in one or some of the following audit types.
    • Investigator Site Audits (GCP)
    • Service Provider/Vendor Audits (GCP/PV)
    • Internal Systems and Process Audits (GCP and PV)
    • Submission specific Clinical Documents audit such as CSR/TMF (GCP)
    • Computer System Audits (GCP/PV)
    • Audit of Licensing Partners & Affiliates (PV)
  • Demonstrated knowledge of ICH GCP E6 R2, FDAs 21 CFRs and guidance/predicate laws
  • General awareness and understanding of systems and tools used for clinical trials such EDC, IxRS, CTMS, EMR, eTMF, eCOA and CDR. Additional awareness of audit tools such as eQMS, Trackwise, Mastercontrol, Veeva etc
  • Understanding of ALCOA+ Data Integrity and GDPR regulations
  • Understanding of Computerized Systems Validation (CSV) and associated processes, ER/ES and applicable regulations such as 21 CFR Part 11 and EU Annex 11.
  • Thorough understanding of QIs and their trending analysis, KQIs, QRI and QTL attributes
  • Proficiency in understanding CAPA and CAPA lifecycle (Initiation, Facilitation, Approval and Implementation) including sources, triage, root cause analysis, effectiveness checks etc.
  • Ability to conduct activities without supervision and applies systemic approach and strategy to address any organizational risks identified through audits.
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 5 years pharmaceutical experience, at least 2 of which are in the GCP/PV audits
  • Ability to be 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
  • Ability to travel up to 25%
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
Manager, QA GxP Audits

City
Basking Ridge

Functional Area
Quality Assurance

State
New Jersey