Director, Global Quality Systems - Lexington, MA

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Supports compliant implementation and continual improvement of quality activities such as daily use of integrated electronic systems. · Familiar with Document Control/Records Management requirements · ...

This position is currently classified as hybrid in accordance with Takeda's Hybrid and Remote Work policy. · Astrategic, innovative mindsetwith the ability to shape and execute a long-term vision for global quality systems while delivering tangible, short-term improvements. · Ext ...

The Quality System Specialist / Senior Quality System Specialist plays a key role in supporting and enhancing Vaxess Technologies' Quality Management System (QMS) to ensure compliance with applicable GMP/GLP standards. · ...

Location: Woburn, MA (on-site 5 days per week) · Vaxess is developing a pipeline of next-generation therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the Vaxess' patch combines room temperature stability with simplified applica ...

The Director, Quality Systems and Compliance provides strategic direction and oversight of the Quality Systems and Quality Compliance functions at ElevateBio to ensure execution and performance meets regulatory requirements and current industry best practices.You will be responsi ...

Support the global Quality Systems and their operations in ensuring compliance and fit for intended use in accordance with applicable global SOPs. · ...

Job summary:The job involves supporting the global Quality Systems and their operations in ensuring compliance and fit for intended use in accordance with applicable global SOPs. The specialist will assist in governance of Quality System applications , participate in meeting/work ...

The Quality System Specialist will support global Quality Systems under the QS&C management team to ensure compliance and fit for intended use in accordance with applicable global SOPs. · ...

We are seeking a Quality System Specialist to support the global Quality Systems and their operations in ensuring compliance and fit for intended use in accordance with applicable global SOPs. · ...

The Role:  · We are seeking a motivated and detail-oriented Summer Quality Systems Intern to support key operational activities within our Quality and Training Systems. This internship offers hands-on exposure to regulated industry practices, including document control, training ...

· At WHOOP, we're on a mission to unlock human performance and health span. WHOOP empowers its members to perform at a higher level through a deep understanding of their bodies and daily lives.  · WHOOP is looking for a Regulatory Affairs Specialist II to be a core member of the ...

This position plays a key role in supporting daily manufacturing activities by resolving operational issues and driving high-quality investigations. · 6+ years experience in pharma/biotech manufacturing environments. · Proven background in investigations, RCA, QC analytics, and G ...

We are looking for a Regulatory Affairs Specialist II to execute regulatory strategy and support QMS maintenance deliverables in a dynamic and agile environment. · Support and submit U.S. regulatory documentation including Q-submissions, De Novo requests, 510(k)s, product change ...

WHOOP is looking for a Regulatory Affairs Specialist II to be a core member of the Digital Health team at WHOOP. · This role requires creative problem-solving and adaptability in an innovative and evolving space. · ...

We're on a mission to unlock human performance and health span at WHOOP. · Support and submit U.S. regulatory documentation including Q-submissions. · Create detailed regulatory deliverables for global distribution of medical devices. · Prepare regulatory submissions for medical ...

Location: · Remote, onshore in the USA · Salary: · $125k to $185k per year depending on experience and skills · How to Apply: · Please submit your resume and a cover letter (in .pdf) that a) highlights your relevant experience related to the qualifications listed below; b) explai ...

We are looking for a Quality Systems Engineer to join our team in Somerville, MA. As a progressive-minded quality professional, you will thrive in a fast-paced, high-growth environment and have the opportunity to drive our digital transformation efforts. · ...

Who is Fikst? · Re:Build Fikst, LLC (Fikst), a Re:Build Manufacturing, LLC (Re:Build) company is a growing product design and engineering consulting firm located in Wilmington, MA. We work with pioneering clients to develop their technology, design their products, and bring those ...

This role is to own and manage individual QMS processes and ensure their ongoing compliance and continuous improvement cross functionally.We are looking for a Quality Systems Engineer who can lead quality and validation-related discussions with incoming and existing customers. · ...