Director of Quality Assurance
6 days ago
The Director of Quality Assurance will be responsible for handling GMP Quality Operations for drug substance activities, managing CSPs, vendors and CMOs. This person will be building out a team of direct reports and will be playing a critical role as the company moves from late-clinical to commercialization.
Responsibilities:
- Providing phase-appropriate oversight of internal and external QA operation activities
- Oversight/management of manufacturing and quality control operations for programs in early and late stages
- Handling Drug Substance oversight of contract service providers, including review of master/executed batch records, analytical test data, specifications
- Review/Approve validation protocols/reports, analytical test methods, stability reports
- Support QMS implementation, including vendor management, CAPAs/Deviations/Change Controls
- Support Supplier Quality activities including audits
- Contribute to CMC sections of submissions
- Leadership responsibilities (cross-functional + building out a team)
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Clinical Quality Assurance Director
1 week ago
South San Francisco, California, United States GQR Full timePosition Title: Director of Clinical Quality AssuranceLocation: South San FranciscoEmployment Status: Full-time direct hire; Hybrid role with 3 days on-siteThe Director of Clinical Quality Assurance (CQA) plays a pivotal role in overseeing that clinical trials comply with relevant GCP regulations, including FDA guidelines, international standards, and...
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Clinical Quality Assurance Director
1 week ago
South San Francisco, California, United States GQR Full timePosition Title: Director of Clinical Quality AssuranceLocation: South San FranciscoEmployment Status: Full-time direct hire; Hybrid role with 3 days onsiteThe Director of Clinical Quality Assurance (CQA) is a pivotal role that demands active engagement in ensuring that clinical trials comply with relevant GCP regulations (such as FDA, international, and...
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Director, Quality Assurance
3 weeks ago
South San Francisco, United States GQR Full timeTitle: Director, Quality Assurance (Drug Substance)Location: South San Francisco, CAHybrid: 3-4 days a week onsiteCompensation: Annual Salary of $230,000Annual bonus of 20%plus equity in shares of optionsWe are seeking an experienced professional to join our team as Director, of Quality Assurance.This role will provide oversight of drug substance contract...
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Director, Quality Assurance
3 weeks ago
South San Francisco, United States GQR Full timeTitle: Director, Quality Assurance (Drug Substance)Location: South San Francisco, CAHybrid: 3-4 days a week onsiteCompensation: Annual Salary of $230,000Annual bonus of 20%plus equity in shares of optionsWe are seeking an experienced professional to join our team as Director, of Quality Assurance.This role will provide oversight of drug substance contract...
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Director, Clinical Quality Assurance
1 month ago
South San Francisco, United States GQR Full timeTitle: Director, Clinical Quality AssuranceLocation: South San FranciscoStatus: Full-time direct hire; Hybrid role 3 days a week onsiteThe Director of Clinical Quality Assurance (CQA) is a hands-on position responsible for ensuring clinical trials adhere to applicable GCP regulations (e.g., FDA, ex-US, country-specific), ICH guidelines, Standard Operating...
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Director, Clinical Quality Assurance
1 month ago
South San Francisco, United States GQR Full timeTitle: Director, Clinical Quality AssuranceLocation: South San FranciscoStatus: Full-time direct hire; Hybrid role 3 days a week onsiteThe Director of Clinical Quality Assurance (CQA) is a hands-on position responsible for ensuring clinical trials adhere to applicable GCP regulations (e.g., FDA, ex-US, country-specific), ICH guidelines, Standard Operating...
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Clinical Quality Assurance Director
1 week ago
South San Francisco, California, United States GQR Full timePosition Title: Director of Clinical Quality AssuranceLocation: South San FranciscoEmployment Status: Full-time direct hire; Hybrid role with 3 days onsiteThe Director of Clinical Quality Assurance (CQA) is a pivotal role that involves active participation in ensuring that clinical trials comply with relevant Good Clinical Practice (GCP) regulations,...
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Director of Quality Assurance
5 days ago
South San Francisco, United States GQR Full timeThe Director of Quality Assurance will be responsible for handling GMP Quality Operations for drug substance activities, managing CSPs, vendors and CMOs. This person will be building out a team of direct reports and will be playing a critical role as the company moves from late-clinical to commercialization. Responsibilities:Providing phase-appropriate...
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Senior Director of Quality Assurance
4 hours ago
South San Francisco, California, United States Annexon Bioscience Full timeJob SummaryAnnexon Biosciences is seeking a highly experienced Senior Director of Quality Assurance to lead our quality management efforts. As a key member of our leadership team, you will be responsible for ensuring the quality and compliance of our products and processes.Key ResponsibilitiesQuality Leadership: Provide strategic direction and oversight for...
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Associate Director, Quality Assurance GMP
6 days ago
South San Francisco, United States Kanvas Biosciences Full timeAbout Us Kanvas Biosciences is a biotechnology company dedicated to studying and leveraging the microbiome towards developing next-generation treatment strategies. As a leader in microbial imaging and therapeutics, we're passionate about illuminating host-microbiome interactions with our advanced microscopy tools and leveraging them to create the next...
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Associate Director, Quality Assurance GMP
5 days ago
South San Francisco, United States Kanvas Biosciences Full timeAbout Us Kanvas Biosciences is a biotechnology company dedicated to studying and leveraging the microbiome towards developing next-generation treatment strategies. As a leader in microbial imaging and therapeutics, we're passionate about illuminating host-microbiome interactions with our advanced microscopy tools and leveraging them to create the next...
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Director, Quality Assurance
2 weeks ago
san francisco, United States GQR Full timeTitle: Director, Quality Assurance (Drug Substance)Location: South San Francisco, CAHybrid: 3-4 days a week onsiteCompensation: Annual Salary of $230,000Annual bonus of 20%plus equity in shares of optionsWe are seeking an experienced professional to join our team as Director, of Quality Assurance.This role will provide oversight of drug substance contract...
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Director, Quality Assurance
1 week ago
san francisco, United States GQR Full timeTitle: Director, Quality Assurance (Drug Substance)Location: South San Francisco, CAHybrid: 3-4 days a week onsiteCompensation: Annual Salary of $230,000Annual bonus of 20%plus equity in shares of optionsWe are seeking an experienced professional to join our team as Director, of Quality Assurance.This role will provide oversight of drug substance contract...
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Director, Quality Assurance Drug Product
1 month ago
South San Francisco, United States GQR Full timeTitle: Director, Quality AssuranceLocation: South San Francisco, CAHybrid: 3-4 days a week onsiteCompensation: Annual Salary of $230,000Annual bonus of 20%plus equity in shares of optionsWe are seeking an experienced professional to join our team as Director, of Quality Assurance.This candidate will be responsible for Quality Operations and oversight of...
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Director, Quality Assurance Drug Product
1 month ago
South San Francisco, United States GQR Full timeTitle: Director, Quality AssuranceLocation: South San Francisco, CAHybrid: 3-4 days a week onsiteCompensation: Annual Salary of $230,000Annual bonus of 20%plus equity in shares of optionsWe are seeking an experienced professional to join our team as Director, of Quality Assurance.This candidate will be responsible for Quality Operations and oversight of...
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South San Francisco, California, United States GQR Full timeJob SummaryGQR is seeking a highly experienced Director of Clinical Quality Assurance to join our team. As a key member of our organization, you will be responsible for ensuring the highest level of quality in our clinical trials.Key ResponsibilitiesRepresent Clinical Quality at Program Team MeetingsProvide operational quality guidance to development...
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Senior Director, Quality Assurance
4 days ago
South San Francisco, California, United States Hibio Full timeJob SummaryWe are seeking a highly experienced and strategic Senior Director, Quality Assurance to join our team at Hibio. This role will be responsible for overseeing and participating in the development, implementation, and maintenance of quality management practices and systems to ensure compliance with internal policies, business objectives, procedures,...
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Director, Clinical Quality Assurance
2 months ago
South San Francisco, United States Abdera Therapeutics Full timeJob DescriptionJob DescriptionWho 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...
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Senior Director of Clinical Quality Assurance
2 months ago
South San Francisco, California, United States Alumis Inc. Full timeAlumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. Alumis is hiring a Clinical Quality Assurance...
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Senior Director of Clinical Quality Assurance
2 months ago
South San Francisco, United States Alumis Inc. Full timeAlumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. Alumis is hiring a Clinical Quality...