Global Head of Quality — Devices & Combination Products
Biogen, Inc.
Biogen, Inc. is seeking a Head of Quality for Device and Combination Products to lead global quality strategy at our Cambridge, MA headquarters. The role requires a visionary leader to ensure compliance with regulatory standards, oversee quality management, and support both internal and external audits. We seek candidates with strong project management skills, extensive experience in medical devices, and a deep understanding of quality systems. A minimum of 12 years of relevant experience is required for this pivotal role. #J-18808-Ljbffr Biogen, Inc.
$10k
## Head of Quality, Device and Combination ProductsApplyremote type: Hybridlocations: Cambridge, MAtime type: Full timeposted... ...of Quality for Device and Combination Products, you will lead the development and execution of the global quality strategy, focusing on devices...SuggestedTemporary workLocal area- ...The Role We are looking for a Head of Quality to build and lead Eyebot’s... ...function as we scale our medical device operations across the United... ...EU MDR, UKCA, and other global certifications, while... ...location. The chance to build products that improve lives and redefine...SuggestedFull timeWork at officeFlexible hours
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- ...About The Role We are looking for a Head of Quality to build and lead Eyebot's quality and... ...assurance function as we scale our medical device operations across the United States and... ...management, incoming inspection, and production controls - that sustain product quality...SuggestedFull timeWork at officeFlexible hours
$148k - $222k
...Quality Product Complaints Associate Director The Quality Product Complaints... ...Quality System and the Global Recall and Defect... ...- e.g. QA operations, MSAT, Device Engineering Operational... ...., small molecule, devices/ combination products, biologics, cell and...Contract workWork experience placementSummer workRemote workFlexible hours2 days per week- Eyebot is on the lookout for a Head of Quality to lead their quality and regulatory function as they expand. The ideal candidate will drive regulatory strategies, develop a robust QMS, and ensure compliance with FDA and international frameworks. This is a full-time role...Full timeFlexible hours
$260k - $320k
...Position Overview: The Senior Director, Product Quality Assurance, Cambridge (PQA) will be... ...activities in the Cambridge location, and globally from a GMP perspective. Primary... ...the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture...Full timeContract workWorldwide- ...Zenas is a clinical-stage global biopharmaceutical company committed... ...diseases. Our core business strategy combines our experienced leadership team with a disciplined product candidate acquisition approach... ...to the Sr. Director of Global Quality Assurance, Clinical Development...Remote work
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$186.49k - $278.88k
...The Director, Global Product Quality, GMP Processes is a strategic leadership role responsible for benchmarking, standardizing, and optimizing global quality processes across the organization. This role ensures that product quality systems are aligned with Good Manufacturing...Temporary workWork at officeLocal areaFlexible hours$184k - $276k
...Summary: The Director, Quality Analytics is... ...across modalities and product lifecycle stages. This... ...projects or the equivalent combination of education and... ...pharmaceutical, biotechnology or device industry solving... ...Information Vertex is a global biotechnology company...Summer workRemote workFlexible hours2 days per week$220k - $300k
...Nova Biomedical: One Global Brand. One Vision. Together... ...to our customers. By combining our strengths, we're accelerating... ...The Senior Director of Quality focuses on assuring... ...plans related to product development as well as... ...medical diagnostic or device experience managing a quality...Hourly payWork at officeFlexible hours- ...solutions for demanding medical device, biotech and... ...efficient scale-up, a consistent, quality supply, or any combination thereof. Their experienced... ...delivering value to customers globally through a strong set of... ...requirements of new products/programs as well as ensuring...Work at officeFlexible hours
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...diseases that have high unmet need. As a global leader in the biology of the... ...motivated Senior Director of Global Quality Control. Reporting to the Head of Global Quality, this position is... ...partners supporting drug substance, drug product, raw materials, in-process, release,...Contract work$178k - $245k
About This Role: As the Head of IT Quality, you will spearhead the strategic direction for ensuring... ...that Biogen's digital systems meet global quality and compliance standards,... ...through an analytical approach utilizing a combination of factors including, but not limited...Full timeTemporary workLocal area$100k - $125k
Service Quality & Metrology Manager Location: Boston, US Vaisala is a global leader in measurement instruments... ...optimizing renewable energy production, our technology is... ...field, or equivalent combination of education and... ...years in a Pharma/Med‑Device or similarly regulated...Temporary workFor contractorsFor subcontractorWork at officeRemote workFlexible hours$265k - $300k
A clinical-stage biotechnology company is seeking an Executive Director of Clinical Quality Assurance to oversee quality assurance for clinical trials. This remote role requires expertise in GCP, GPvP, and GLP, ensuring compliance with regulations. Responsibilities include...Remote work$160k - $180k
...potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our follow-on product candidate, OP-3136, is a... ...Senior Manager, GCP Clinical Quality As the Senior Manager, GCP Clinical... ...based GCP compliance approach globally * Support Quality Management...Work at officeFlexible hours2 days per week$131.9k - $161.2k
About Us SharkNinja is a global product design and technology company, with a diversified portfolio of 5-star rated... ...hasn’t been invented yet, you’ll fit right in. Quality System Compliance Manager, Medical Devices As the Quality System Compliance Manager,...Full timeTemporary workLocal areaFlexible hours$238.3k - $327.66k
...caring environment forms a global community that celebrates... ...step in your career. As Head of Endovascular Robotics (EVR) Quality & Regulatory Affairs, you... ...strategy supporting new product development, market access... ...the lifecycle of medical device product development....Temporary workWork at officeLocal area- ...Nanobiosym is looking for a Quality Manager for its High-Complexity... ...CLIA, FDA and other global regulatory authorities. Position... ...regulatory submissions for all new products and modifications to existing... ...regulatory bodies. Medical device and/or invitro diagnostics...Full timeImmediate start
$213k
...Director, Quality Control Menlo Park, California, United States... ...Director, Quality Control – Combination Products will provide strategic and... ...inspection-ready and aligned with global regulatory expectations for... ..., autoinjectors, and device constituent components. Ensure...Contract workWork at officeLocal areaRemote work3 days per week$110k - $150k
...lead platform, PRIME Nexus™, combines reusable hardware with software... .... Role Information Title: Quality Manager Reports to: VP, Quality... ...drug delivery device, including DHF maintenance, design... ...file maintenance throughout the product lifecycle • Manage complaint...Temporary workCasual workWork at officeFlexible hours$109k - $140k
...of interdisciplinary experts combine innovative thinking and breakthrough... .... Our teams operate globally from offices across the UK,... ...and digitally connected products. We combine the application of... ...We are seeking a US Quality Manager to work in collaboration...Shift work$155k - $214k
About This Role:As the Associate Director, Global Quality Risk Management, you will be at the forefront of Biogen’s commitment to quality... ...is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills &...Temporary workLocal area$160k - $180k
...potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our follow‑on product candidate, OP‑3136, is a... ...Senior Manager, GCP Clinical Quality reporting to the Senior Director... ...based GCP compliance approach globally. Support Quality Management System...Work at office2 days per week$140k - $160k
...partnerships with leading global biopharmaceutical... ...Zai currently has four products on the market in China... ...conducting independent quality control (QC)... ...the Executive Director, Head of US Clinical Operations... ...activities; or equivalent combination of higher education, training...Work at officeRemote workWorldwideRelocation package$245k - $335k
A biopharmaceutical company in Cambridge is seeking a Senior Director of Global Quality Control. The role involves leading the global QC function across an outsourced model, ensuring compliance with regulatory standards, and providing strategic oversight for QC activities...- Bicara Therapeutics is seeking a Senior Director, Quality Management Systems in Boston to build and lead the company’s QMS from the ground up. This leadership role will ensure operational efficiency and compliance with GxP activities. The ideal candidate will have over...
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