Director, Clinical Quality Assurance
Company: Fusion Pharmaceuticals
Location: Chelsea
Posted on: August 4, 2022
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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
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