Head of Quality
2 days ago
We are seeking a Head of Quality & Regulatory Affairs to own and scale our quality system and regulatory strategy as we advance from pre-clinical development into clinical trials and early commercialization. This role is both strategic and hands-on . You will design and implement a fit-for-purpose QMS, define regulatory pathways, lead agency interactions, and act as the internal authority on quality, compliance, and risk. You will be a core member of the leadership team and a key partner to R&D, Manufacturing, Clinical, and Operations. Key Responsibilities Design, implement, and maintain a scalable Quality Management System (QMS) aligned with: FDA (21 CFR 820, 21 CFR 210/211 as applicable), ISO 13485 / ISO 9001 (as appropriate), GLP / GCP / GMP interfaces Own quality governance including: SOPs, change control, CAPAs, deviations, complaints, Risk management (ISO 14971), Document control and training systems Serve as the final authority on quality decisions, balancing speed with compliance Lead internal audits and support external audits, inspections, and partner diligence Define and own the regulatory strategy across product lines (device, biologic, combination product, or hybrid pathway as applicable) Lead FDA interactions including: Pre-Subs / Q-Subs, IND / IDE strategy (as applicable), briefing documents and meeting leadership Advise leadership on regulatory risk, sequencing, and trade-offs Interface with global regulators as needed (EMA, MHRA, etc.) Embed quality and regulatory thinking early into: R&D and preclinical study design, manufacturing process development, vendor qualification and tech transfer Partner closely with: R&D / Preclinical, Clinical, Manufacturing & Supply chain, Operations & Program Management Act as a translator between technical teams and regulators Initially operate as a player-coach / IC Hire and develop QA and RA team members over time Establish external partner strategy (consultants, CROs, notified bodies, etc.) Build systems that will scale through clinical trials and toward commercialization Qualifications 5+ years of experience in Quality, Regulatory Affairs, or combined QA/RA in biotech, medtech, or combination products Direct experience building or scaling a QMS in an early- or mid-stage company Handson experience leading FDA interactions (Pre-Sub, IND, IDE, or equivalent) Strong working knowledge of: FDA regulations (21 CFR 820, 210/211, 11 as relevant), ISO 13485 and risk management frameworks Track record of sound judgment in ambiguous, fastmoving environments Ability to operate at both strategic and execution levels Preferred / Nice to Have Experience with IDE, firstinhuman or novel modalities Combination product or platform technology experience Prior inspection or audit leadership experience Experience in organ preservation, devices, biologics, or translational research (contextdependent)$180,000 - $350,000 a year #J-18808-Ljbffr
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Head of Quality
3 hours ago
San Francisco, CA, United States Until Full timeA leading biotech company is seeking a Head of Quality & Regulatory Affairs to advance their quality system as they transition into clinical trials. The role requires strategic thinking and hands-on implementation of QMS aligned with FDA and ISO standards. Candidates should have over 5 years of relevant experience and strong knowledge of regulatory...
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Head of Quality
7 hours ago
San Francisco, United States Until Full timeA leading biotech company is seeking a Head of Quality & Regulatory Affairs to advance their quality system as they transition into clinical trials. The role requires strategic thinking and hands-on implementation of QMS aligned with FDA and ISO standards. Candidates should have over 5 years of relevant experience and strong knowledge of regulatory...
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Head of Ads Quality Engineering
2 days ago
San Francisco, CA, United States Whatnot Full timeJoin to apply for the Head of Ads Quality Engineering role at Whatnot If you would like to know a bit more about this opportunity, or are considering applying, then please read the following job information. This range is provided by Whatnot. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay...
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Head of Quality
4 hours ago
San Francisco, CA, United States Until Full timeWe are seeking a Head of Quality & Regulatory Affairs to own and scale our quality system and regulatory strategy as we advance from pre-clinical development into clinical trials and early commercialization. You will design and implement a fitforpurpose QMS, define regulatory pathways, lead agency interactions, and act as the internal authority on quality,...
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Head of Medical Operations
2 weeks ago
San Francisco, CA, United States University of California - San Francisco Full timeHead of Operations for READY Center Full Time This is a 1 year Contract Position The Head of Operations will provide supervision and guidance to research and technical staff, ensuring alignment with the strategic objectives of the Research and Engineering to Accelerate DiscoverY (READY) Center at QBI. The appointee will oversee program administration,...
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Head of Ads Quality Engineering
2 days ago
San Francisco, CA, United States Whatnot Full timeJoin to apply for the Head of Ads Quality Engineering role at Whatnot This range is provided by Whatnot. Your actual pay will be based on your skills and experience talk with your recruiter to learn more. Base pay range $280,000.00/yr - $410,000.00/yr About Whatnot 🚀 Join the Future of Commerce with Whatnot! Whatnot is the largest live shopping platform...
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Head of Quality Assurance
2 weeks ago
San Francisco, CA, United States Abdera Therapeutics Inc. Full timeAbdera Therapeutics Inc. is a precision oncology company developing next-generation targeted radiation therapies- one of the most cutting-edge and highly promising areas of drug development. The company is built on a proprietary modular technology platform optimized for the delivery of radioisotopes to selectively destroy tumor cells while sparing healthy...
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Head of Quality
8 hours ago
San Francisco, United States Until Full timeWe are seeking a Head of Quality & Regulatory Affairs to own and scale our quality system and regulatory strategy as we advance from pre-clinical development into clinical trials and early commercialization. This role is both strategic and hands-on. You will design and implement a fit-for-purpose QMS, define regulatory pathways, lead agency interactions, and...
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Head of Quality Assurance
4 weeks ago
San Francisco, CA, United States Abdera Therapeutics Inc. Full timeWho we are Abdera Therapeutics Inc. is a precision oncology company developing next-generation targeted radiation therapies- one of the most cutting-edge and highly promising areas of drug development. The company is built on a proprietary modular technology platform optimized for the delivery of radioisotopes to selectively destroy tumor cells while sparing...
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Head of Medical Operations
4 weeks ago
San Francisco, CA, United States University of California, San Francisco Full timeThe Head of Operations will provide supervision and guidance to research and technical staff, ensuring alignment with the strategic objectives of the Research and Engineering to Accelerate DiscoverY (READY) Center at QBI. The appointee will oversee program administration, development, and operational execution, translating high-level objectives into...
