Auditor, GCP/GLP/Quality Assurance

Fusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical-stage oncology company focused on developing next-generation radioconjugates (RCs) as precision medicines.  Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors.  Fusion’s clinical portfolio includes:  FPI-2265 targeting prostate specific membrane antigen (PSMA) for metastatic castration resistant prostate cancer currently in a Phase 2 trial;  FPI-1434 targeting insulin-like growth factor 1 receptor currently in a Phase 1 trial;  FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1), currently in a Phase 1 trial; and FPI-2068, a bispecific IgG-based EGFR-cMET targeted radioconjugate currently in a Phase 1 trial.  In addition, Fusion is pursuing combination programs between RCs and DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. Fusion has a fully operational Good Manufacturing Practice (GMP) compliant state-of-the-art radiopharmaceutical manufacturing facility to meet supply demand for Fusion's growing pipeline of RCs.  

Position Summary

Fusion has opened a newly created role in Quality Assurance for an Auditor, GCP/GLP/ Quality Assurance.  This position will focus on GCP and GLP compliance within Fusion sponsored clinical trials and the R & D organization and provide clinical study oversight in preparation for commercialization.  This position must have at least 1 year of GCP auditing experience for clinical sites and vendors. They will also have experience with participating with clinical study team s in the execution of study protocols. This role will report to the Sr Director of Clinical Quality Assurance.

Responsibilities

•    Represent the GCP/GLP/PV Quality function on various clinical project teams and other working groups, functional areas, and with external partners providing GCP/GLP/PV oversight and supporting R&D clinical development programs through post marketing.

•    Ensures, where appropriate, that all personnel training, investigation, deviation actions, critical documentation and audit actions are completed and compliant for GLP and GCP studies

•    Executes against approved GLP and GCP audit plans and other GLP/GCP-related documents.

•    Participate and lead internal and external audits to assess compliance with GCP & GLP requirements, investigational plans, and Fusion standards for clinical trial related activities.

•    Provide consultation to Clinical Operations and Quality Assurance regarding GCP & GLP quality practices and issues.

•    Reviews GLP and GCP protocols, GLP and GCP study reports, and Standard Operating Procedures to ensure GLP and GCP compliance.

•    Assists the Nonclinical team with GLP compliance for animal rule and non-animal rule therapeutics and the Clinical team with GCP compliance for clinical studies.

•    Ensures required Quality Assurance expertise is available and effective for GLP and GCP study execution.

•    Support deployment and implementation of HIPPA, Data Integrity and GxP's

•    Ensuring regulatory commitments are met on time and sustainability measures are in place.

•    Ensuring where appropriate that all personnel training, investigation, deviation actions, critical documentation and audit actions are completed on time.

•    Ensuring escalation to the Sr Director of Clinical Quality Assurance and leadership of all critical concerns from the site related to clinical quality issues encountered at the CRO and partner's quality system.

Qualifications

•    Bachelors Degree or equivalent is required, advanced degrees a plus

•    Certification in GCP Quality Auditing, a plus

•    Minimum of 5 years of work experience in the pharmaceutical industry and at least 1-2 years performing Clinical Quality Assurance functions (GCP) for clinical trials phases I-IV including the auditing of clinical investigators and CROs/vendors.

•    Knowledge of GxP/PV quality systems, quality assurance, quality control, and GCP/GLP/PV audits.

•    Experience supporting IT systems audits and understanding of GCP and GLP quality standards and practice is highly desired.

•    High level of written and oral communication skills and presentation skills.

•    Use of Microsoft Office (Excel, Word, Microsoft Project, PowerPoint).

•    Strong interpersonal and communication skills

•    Strong written and verbal communication skills

•    Effective/concise communicator with management and internal teams

•    Experience with working in start-up environments moving in rapid growth/manufacturing

•    Influences a strong quality and compliance culture internally and externally

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual, gender identity, national origin, disability, or status as a protected veteran.