- Quality Systems in alignment with current business processes.
- QMS Veeva Vault is maintained in accordance with current regulatory compliance requirements and meets current corporate quality and business objectives.
- Smartsheet and SharePoint are a plusAbility to work effectively on multiple projects simultaneously with minimum supervisionStrong 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/manufacturingAll 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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Director, Quality Management Systems - Somerville, United States - Fusion Pharmaceuticals LLC
Description
Fusion Pharmaceuticals (NASDAQ:
FUSN) is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors.
Fusions 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; and FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1), currently in a Phase 1 trial.
In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop novel targeted alpha therapies (TATs) and combination programs between Fusions TATs and AstraZenecas DNA Damage Response Inhibitors (DDRis) and immune-oncology agents.
Fusion has also entered into a collaboration with Merck to evaluate FPI-1434 in combination with Mercks KEYTRUDA (pembrolizumab) in patients with solid tumors expressing IGF-1R.
To support Fusions growing pipeline of TATs, the company has signed strategic actinium supply agreements with TRIUMF, Niowave, and BWXT Medical.
Position SummaryFusion has opened the role in Quality Assurance for a Director, Quality Management System (QMS).The successful candidate will be responsible for leading the development, design and maintenance of the Quality Management System with the goal of maximizing efficiency, effectiveness and compliance with all appropriate quality regulations and standards of practice.
This role will report to the Head of Quality Assurance.Key ResponsibilitiesEnsure compliance with cGXP regulations while overseeing the continual evaluation and advancement of quality standards and requirements.
Oversee the design, development, roll-out and maintenance of a Global GxP e
Drive the corporate cGxP document management program. Ensuring the workflows and documents are aligned in the Veeva Quality Vault.
Ensure the e
Will define and generate quality performance and compliance metrics.
Develop, establish write and implement QA SOPs and supporting documentation as necessary.
Promote Quality and GxP awareness across the organization including training initiatives.
Facilitate the development and maintenance of quality systems supporting pre-clinical, clinical, manufacturing and distribution activities.
Represent QMS in departmental or team teract effectively with company management, internal departments and other sites to effectively implement and maintain the company QMS.Foster a culture of accountability with progressively increased empowerment.
Required QualificationsBachelors degree in Life Sciences, or related fieldExperience with Veeva Quality Vault eDMS/eQMS and Compliance Wire eLMS required Worked in an FDA regulated environment and familiar with Health Authority regulations and guidanceMinimum of 10-12 years with increasing levels of responsibility in cGMP/Quality Management SystemsHighly Proficient in Word, Excel, and PowerPoint
