Director, Clinical Quality Assurance

Company: Fusion Pharmaceuticals
Location: Chelsea
Posted on: August 4, 2022

Job Description:

Fusion Pharmaceuticals (NASDAQ: FUSN) is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines to treat a broad range of cancers. Employing its platform technology, including proprietary Fast-Clear linker, Fusion connects alpha particle emitting isotopes to antibodies and other targeting molecules in order to selectively deliver the payloads to tumors. Fusion's lead program, FPI-1434, is currently in a Phase 1 clinical trial. The Company is growing a pipeline of precision oncology therapies in development, and recently announced a collaboration agreement with AstraZeneca. Position SummaryFusion has opened a newly created role in Quality Assurance for a Director, Clinical Quality Assurance. This position will focus on GCP and GLP compliance within Fusion sponsored clinical trials and the R & D organization and provide PV QA oversight in preparation for commercialization. This position will support quality management systems to ensure compliance and minimize risk in a regulated pharmaceutical environment. This role will report to the Head of Quality Assurance. Key ResponsibilitiesRepresent 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.Develop plans for quality oversight of GCP activities for clinical trials, ensuring compliance with global quality systems across Fusion locations with focus on GCP/GLP/PV.Acts as a SME on any QA-GLP and QA-GCP issues; contributes as SME for matters relating to formal quality management and regulatory compliance at nonclinical and clinical sites in collaboration with the Head of Quality AssuranceDevelops and ensures risk management principles and a continuous improvement culture are built into QA ways of working.Ensures the Nonclinical GLP and Clinical sites are "Audit ready" and compliant at all times.Ensures, where appropriate, that all personnel training, investigation, deviation actions, critical documentation and audit actions are completed and compliant for GLP and GCP studiesWrites GLP and GCP audit plans and other GLP/GCP-related documents.Overseeing conduct of and participating in the conduct of internal and external audits to assess compliance with GCP & GLP requirements, investigational plans, and Fusion standards for clinical trial related activities.Serving as a senior advisor to the Head of Quality, and to the Executive Management Team 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'sActing as point of contact with regulatory authorities regarding issues at the clinical trial sites.Ensuring regulatory commitments are met on time and sustainability measures are in place.Maintain good relationship with Regulatory bodies as well as Global Health Authority and Food and Drug Administration (FDA) inspectorsEnsuring required Quality Assurance management and quality expertise is available and effective for operations.Ensuring where appropriate that all personnel training, investigation, deviation actions, critical documentation and audit actions are completed on time.Ensuring escalation to the Head of Quality Assurance and leadership of all critical concerns from the site related to product quality issues encountered at the CRO and partner's quality system.Assists in constructing annual GLP and GCP training and requirements.Required QualificationsMaster's Degree or equivalent is required, advanced degrees a plusCertification in GCP Quality Auditing, a plusMinimum of 10-12 years of work experience in the pharmaceutical industry and at least 8 years performing Clinical Quality Assurance functions (GCP) for clinical trials phases I-IV including the auditing of clinical investigators and CROs/vendors.In depth knowledge of GxP/PV quality systems, quality assurance, quality control, and GCP/GLP/PV audits.Hands-on experience in regulatory inspections, vendor audits, vendor qualification, and internal audits is required.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 skillsAbility to design and implement global business processes/policies with a critical thinking approach and enterprise mindsetStrong written and verbal communication skillsEffective/concise communicator with management and internal teamsExperience with working in start-up environments moving in rapid growth/manufacturingInfluences a strong quality and compliance culture internally and externallyFusion requires all employees to be current with their COVID vaccination requirements.All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
PDN-9672f2da-a15b-48b5-b0af-2198c21ff5f6

Keywords: Fusion Pharmaceuticals, Chelsea , Director, Clinical Quality Assurance, Executive , Chelsea, Massachusetts