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 but is not limited to: 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; and FPI-2068, a bispecific IgG-based EGFR-cMET targeted radioconjugate currently in a Phase 1 trial. Fusion has multiple other pipeline programs that will soon be entering into early FIH trials. In addition, Fusion is pursuing combination programs between RCs and other therapeutic modalities including DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. To support execution for these programs, Fusion has a fully operational Good Manufacturing Practice (GMP) compliant state-of-the-art radioconjugate manufacturing facility to meet supply demand for our growing pipeline of RCs.
Position Summary
Fusion has opened a newly created role within Quality Assurance, Quality Management Systems for a Senior Quality Management System (QMS) Specialist. This position will focus on GxP compliance and maintenance of the Quality Management Systems (QMS) within Fusion with the goal of maximizing efficiency and effectiveness. This role will be providing operational and administrative process support for the GxP Quality Systems. The role will report to the Senior Director, Quality Management Systems and will be based in the Boston office. Candidates will be expected to work on a hybrid basis.
Responsibilities
• Responsible for the day-to-day activities related to Quality Management Systems (Deviations/Lab Investigations/CAPA/Change Control/Complaints) using Fusion’s validated eQMS (Veeva Vault).
• Collaborate cross functionally to ensure timely completion of eQMS records and provide metrics/KPIs.
• Manage shared inboxes for eQMS systems and QMS board management to discuss and ensure on time closure of records.
• Responsible for ensuring that GxP records are maintained, secure, and retrievable throughout defined retention cycles and comply with business process.
• Responsible for troubleshooting eQMS issues with users, provides business process guidance and hands-on support and liaise with Veeva Administrator as required.
• Serves as business system administrator for the eQMS system.
• Collects user feedback and provides 1:1 assistance as needed.
• Supports inspections by health authorities and maintain a state of inspection readiness.
• Assist in project related work as required, UAT, process exercises in support of eQMS implementation and enhancement projects.
• Support Quality Culture initiatives, such as process improvements, and its corresponding KPI’s based on business needs.
• Perform other QMS projects and duties as assigned.
Qualifications
• Minimum of 6-8 years of previous GxP Quality Management Systems (QMS), experience in a regulated field strongly preferred
• Bachelor's degree, preferably in a scientific discipline or equivalent
• Strong technical background with previous experience working with eQMS and eDMS, Veeva Vault is preferred
• Strong written and verbal communication skills
• Ability to work effectively on multiple projects simultaneously with minimum supervision.
• Experience with working in start-up environments moving in a rapid growth/manufacturing.
• Proficient in MS Word and Excel
• Understanding of GxP regulations including GMP, GCP, GLP, and PV
• 5-10% travel
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.
