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Xybion Corporation
Boston, MA, United States
About Us Serving more than 350 customers in 35+ countries,Xybion (TSXV:XYBN) has the global scale and expertise to bring employees around the world together to drive digital transformation of laboratories.Xybion is a leading ai enabled software as a service company dedicated to helping corporations solve business problems. Through intelligently des
Job Source: Xybion CorporationKura Oncology
Boston, MA, United States
Are you ready to join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines? At Kura Oncology, you have an opportunity to be a part of something bigger, with a lasting impact that you can be proud of. At Kura Oncology, we are working to change the paradigm and improve the sc
Job Source: Kura OncologyShine Associates
Boston, MA, United States
DIRECTOR/ASSOCIATE DIRECTOR, DEVELOPMENT POSITION SPECIFICATION Shine Associates, LLC has been retained to search, identify and recruit a Director/Associate Director, Development on behalf of our client (‘Company’). This person will report directly to the Senior Director, Development. This candidate will be located in the Boston, MA office. CONFID
Job Source: Shine AssociatesAlkermes
Waltham, MA, United States
Job Description Develop and implement a winning cheminformatics strategy that optimally utilizes state-of-the-art AI and ML technologies Derive information, insight, and knowledge from experimental and in silico data through the development, implementation, and application of AI/ML-driven predictive and generative modeling approaches Work closely
Job Source: AlkermesOSI
Boston, MA, United States
Associate Director/Director, Biomarker Position Summary PepGen is looking for a highly motivated Associate Director or Director level Biomarker scientist who will contribute to the preclinical/clinical development to support and expand their current and future pipeline. This person will be a key contributor to the clinical biomarker development an
Job Source: OSIKura Oncology, Inc.
Boston, MA, United States
ESSENTIAL JOB FUNCTIONS: The Associate Director/Director Biostatistics is responsible for providing technical leadership and biostatistical support to Clinical Development through the design and conduct of clinical studies; review and accuracy of clinical data; the evaluation, interpretation, and reporting of study results; and regulatory submissi
Job Source: Kura Oncology, Inc.Stratacuity
Waltham, MA, United States
Associate Director/ Director Biostatistician 2024364 Location: Waltham, MA (Hybrid) Therapeutic Area: Immuno-Oncology Job Overview: This role will lead statistical analyses for early development of clinical trials, support investigators and researchers on experimental design, and collaborate closely with internal teams while reporting to the Head o
Job Source: StratacuityShine Associates
Boston, MA, United States
DIRECTOR/ASSOCIATE DIRECTOR, DEVELOPMENT POSITION SPECIFICATION Shine Associates, LLC has been retained to search, identify and recruit a Director/Associate Director, Development on behalf of our client (‘Company’). This person will report directly to the Senior Director, Development. This candidate will be located in the Boston, MA office. CONFID
Job Source: Shine AssociatesBoston, MA, United States
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. 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; 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 Fusion’s TATs and AstraZeneca’s 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 Merck’s KEYTRUDA (pembrolizumab) in patients with solid tumors expressing IGF-1R. To support Fusion’s 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 an Associate Director/Director, Quality System (QS). The successful candidate will be responsible for leading the development, design and maintenance of the Quality 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
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-QMS 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 QS 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.
Required Qualifications
Bachelor’s degree in Life Sciences, or related field
Experience with Veeva Quality Vault eDMS/eQMS and Compliance Wire eLMS required
Worked in an FDA regulated environment and familiar with Health Authority regulations and guidance
Minimum of 6 years with increasing levels of responsibility in cGMP/Quality Management 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
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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Email Alert for Associate Director/Director, QMS jobs in Boston, MA, United States
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