Job Description

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 role within Quality Assurance, Quality Management Systems for a Document and Training Manager. This position will focus on GxP compliance within Fusion sponsored clinical trials and the R & D organization providing training and documentation management support in preparation for commercialization. This role will be responsible for providing operational and administrative process support for GxP Quality Systems. This role will report to the Senior Director, QMS.

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Responsibilities

• Responsible for the day-to-day activities related to training management for document lifecycle and training programs for Fusion’s validated eLMS (Compliance Wire) and eDMS (Veeva Vault).

• Collaborate cross functionally to ensure timely completion of training and periodic review, develop and provide metrics/KPI

• Manage shared inboxes for Training and Document Management

• Collaborate with Functional leads to develop, maintain and optimize curriculums for GxP functions

• Responsible for ensuring that GxP training records are maintained, secure, and retrievable throughout defined retention cycles and external training documents are integrated into the eLMS

• Responsible for the day-to-day activities related to training including, but not limited to, training audience definition, maintenance training matrix, training content development and delivery using a validated eLMS (Compliance Wire)

• Assign end user training using eLMS, including, on-boarding of new employees, on-going assignments for new procedures, and/or quality initiatives

• Responsible for troubleshooting eLMS and eDMS issues with users, provides business process guidance and hands-on support with training and document

• Serves as primary system administrator and first line of customer support for training business processes and workflows, including assistance in approval routing of GxP documents, training completion entry in LMS and CV and JD management as per established processes

• Collects user feedback for system enhancements and provides 1:1 assistance as needed

• Manage and provide oversight of Document Management processes, eDMS system (Veeva) including but not limited to process improvements, record issuance, record retention and archive

• 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 for eLMS and eDMS as required

• Support Quality Culture initiatives, such as training, process improvements, and its corresponding KPI’s based on business needs

• Perform other QMS projects and duties as assigned

• Ability to manage direct report(s)

Qualificatioms

• Minimum of 5-8 years of previous GxP Training experience, QMS and, Document Control, experience in a regulated field strongly preferred

• Bachelor's degree required, preferably in a scientific discipline or equivalent

• Strong technical background with previous experience working with eQMS Veeva Vault is prefer

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• Strong technical experience with eLMS, UL Compliance Wire is preferred

• Strong written and verbal communication skills

• Proficient in MS Word and Excel

• Understanding of GxP regulations including GMP, GCP, GLP, PV

Fusion Pharmaceuticals is an equal opportunity employer that is committed to inclusive, barrier-free recruitment and selection processes, if contacted for an interview, please advise Human Resources if you require accommodation.

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.

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