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, GXP Quality Assurance. This position will focus on GxP compliance within Fusion Pharmaceuticals internal systems, sponsored clinical trials, manufacturing, and the R & D organization and provide quality systems oversight in preparation for commercialization. This position must have at least 1 year of GXP auditing experience with a focus on internal audits and vendors. The identified candidate will have experience with internal auditing of quality systems, vendor audits. This role will report to the Sr Director of Clinical Quality Assurance.
Responsibilities
• Represent the Quality function on various internal and external audits and other working groups, functional areas, and with external partners in support of Fusion Pharmaceuticals R&D program and manufacturing proccesses.
• Ensures, where appropriate, that all personnel training, investigation, deviation actions, critical documentation and audit actions are completed and compliant through internal self inspection.
• Participate and lead internal and external audits to assess compliance with GXP requirements, investigational plans, and Fusion standards.
• Provide consultation to Quality Assurance and supported functions regarding GXP quality practices and issues.
• Reviews GxP systems, documents, Standard Operating Procedures to ensure compliance.
• Ensures required Quality Assurance expertise is available and effective for GXP 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 quality issues encountered internally, vendors and partner's quality system.
Qualifications
• Bachelors Degree or equivalent is required, advanced degrees a plus
• Certification in Quality Auditing, a plus
• Minimum of 5 years of work experience in the pharmaceutical industry and at least 1-2 years performing internal audits and external audits.
• Knowledge of GxP quality systems, quality assurance, quality control, and GMP/GCP/GLP/PV audits.
• Experience supporting IT systems audits and understanding of GxP quality standards, implementation 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.