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
- 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.
- 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%