- Ensure 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-Quality Systems in alignment with current business processes.
- Oversee the corporate cGxP training program and training records. Work with department heads to develop training curriculums for all GxP personnel.
- Drive the corporate cGxP document management program. Ensuring the workflows and documents are aligned in the Veeva Quality Vault.
- Ensure the e-QS Veeva Vault is maintained in accordance with current regulatory compliance requirements and meets current corporate quality and business objectives.
- Determine drug development phase appropriate quality system program elements.
- 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 meetings.
- Interact 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.
- Bachelors degree in Life Sciences, or related field
- Experience with Veeva Quality Vault eDS/eQS and Compliance Wire eLMS required
- Worked in an FDA regulated environment and familiar with Health Authority regulations and guidance
- Minimum of 10-12 years with increasing levels of responsibility in cGMP/Quality Systems
- Highly Proficient in Word, Excel, and PowerPoint - Smartsheet and SharePoint are a plus
- Ability to work effectively on multiple projects simultaneously with minimum supervision
- Strong interpersonal and communication skills
- Ability to design and implement global business processes/policies with a critical thinking approach and enterprise mindset
- 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
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Director, Quality 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 Summary
Fusion has opened the role in Quality Assurance for a Director, Quality Systems (QS). 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 Responsibilities
Required Qualifications
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-9b1e6806-8aa8-4165-aed8-35e863189a36
