521 Results for

Director Of Quality Assurance Jobs in San Jose, CA

Jobs

Pleasanton, CA30+ days ago

10+ years of relevant regulatory affairs experience in the bioanalytical CRO or biotechnology/pharmaceutical industry, or a combination of education and experience. Crystal Bio Solutions, a member of Crystal Pharmatech, is a leading biologics analytical organization with operations in the San Francisco Bay Area and New Jersey.

San Jose, CA30+ days ago

$192,000–$210,000 Per Year

Data and Metrics Governance • Understand and support existing key performance indicators (KPIs) and quality metrics to ensure process improvements align with organizational objectives • Assess impact of proposed system and data changes on established governance frameworks and data integrity • Collaborate with data governance teams to evaluate risks and opportunities related to metrics and reporting when implementing process changes • Analyze performance data to identify trends, opportunities, and areas for improvement while maintaining alignment with existing measurement systems. • Model: Operational Excellence Focus • Location: San Francisco Bay Area preferred; other northern California locations considered • Success Metrics • Successful implementation of quality improvement initiatives • Measurable improvements in operational KPIs and process efficiency • Effective stakeholder engagement and cross-functional collaboration • Timely completion of assigned projects and deliverables • Knowledge transfer and capability building within client organization.

Alameda, California30+ days ago

$210,000–$250,000 Per Year

GeneFab's technology platform includes bioinformatic-guided discovery of cell type promoters, directed evolution of small molecule-regulated gene switches, and the engineering of highly sensitive kill switches for enhanced safety and control of cellular therapies. A minimum of 15 years of experience in compliance, quality, and CDMO/CMO management with a focus on regulatory documentation and lifecycle management within the pharmaceutical or biotechnology industry is a must, including 10 years of experience in management/leadership roles.

New!

Palo Alto, California3 days ago

HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. The Senior Director QA will report to the Vice President, Quality Assurance and Regulatory CMC, and provide comprehensive GMP quality oversight across the full chemistry, manufacturing, and controls (CMC) lifecycle for Summit’s oncology pipeline.

New!

South San Francisco, CA6 days ago

$250,000–$340,000 Per Year

Nkarta is a publicly traded (Nasdaq symbol NKTX), clinical-stage biotechnology company headquartered in South San Francisco, focused on advancing the development of allogeneic, off-the-shelf natural killer (NK) cell therapies to treat autoimmune disease. While getting better work-life balance and improving communications between groups in an early stage start up environment are two areas on which we are working, here are real, anonymous comments about or regarding why people think Nkarta is a great place to work.

Palo Alto, CA24 days ago

$217,000–$271,000 Per Year

HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. Overview of Role: The Senior Director QA will report to the Vice President, Quality Assurance and Regulatory CMC, and provide comprehensive GMP quality oversight across the full chemistry, manufacturing, and controls (CMC) lifecycle for Summit's oncology pipeline.

South San Francisco, CA30+ days ago

$205,000–$218,000 Per Year

We work hard to bring together diverse teams-grounded in a wide range of expertise and life experiences-and work even harder to ensure those teams thrive in inclusive, growth-oriented environments supported by equitable company and team practices. These powerful models rely on extensive biological and computational infrastructure and allow insitro to advance novel targets and patient biomarkers, design therapeutics and inform clinical strategy.

South San Francisco, CA30+ days ago

$193,000–$242,000 Per Year

The Clinical QA Director is responsible to ensure quality is embedded throughout the lifecycle of all the ongoing clinical programs through oversight, assessment and monitoring, risk assessment tools, auditing and risk mitigations. This involves working closely with Clinical Operations, Clinical Development, Clinical Supply Chain, Data Management, Pharmacovigilance, Medical Affairs, Regulatory, Legal, and other teams across Alumis.

Redwood City, CA30+ days ago

$265,000–$331,000 Per Year

The company's RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. Minimum of 15 years of experience in the pharmaceutical or biotechnology industry, including at least 10 years in GCP QA or clinical quality leadership roles, with demonstrated experience leading and hosting regulatory inspections (e.g., FDA BIMO, EMA, MHRA, PMDA).

Redwood City, California30+ days ago

The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. Minimum of 15 years of experience in the pharmaceutical or biotechnology industry, including at least 10 years in GCP QA or clinical quality leadership roles, with demonstrated experience leading and hosting regulatory inspections (e.g., FDA BIMO, EMA, MHRA, PMDA).

San Francisco, CA30+ days ago

Founded in 2015, the company has built a portfolio of 20+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs. The Director / Senior Director, Quality Assurance is responsible for managing and overseeing the Good Pharmacovigilance Practices (GVP) quality and compliance program at Eidos Therapeutics and other assigned BridgeBio affiliate companies.

South San Francisco, CA30+ days ago

$184,500–$215,250 Per Year

This role will hare strategic responsibility for the QA CSV / CSA function to support cross-functional and QA goals for GXP systems and deliver results for corporate initiatives, as well as independently drive and own multiple complex CSV-related projects in partnership with multiple cross-functional leaders. Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction.

Redwood City, CA30+ days ago

Lead, manage, and train others on GCP audits, including clinical investigative site audits, clinical vendor audits, clinical department internal audits, Trial Master File (TMF) audits, and applicable study document audits, including Clinical Study Reports (CSRs). The Director of Clinical Quality Assurance (CQA) is a senior member of the CQA team and will lead and perform day-to-day clinical quality operations and compliance activities to support the success of the clinical studies sponsored or supported by Corcept.

Brisbane, CA30+ days ago

$170,538–$193,493 Per Year

As a virtual drug developer, Nurix operates through a lean internal infrastructure and relies on a curated ecosystem of Software-as-a-Service (SaaS) and cloud-hosted platforms to support GxP-regulated activities across clinical development, quality operations, manufacturing oversight, and regulatory submissions. The role requires an individual who combines deep technical knowledge of GxP computerized systems with practical experience in SaaS and cloud-based platform qualification, and who can translate regulatory requirements into pragmatic, fit-for-purpose validation approaches that support a modern, agile biotech environment.

New!

Foster City, California3 days ago

Provide quality oversite for the GCP/GVP/GLP vendor activities, including internal/external deviations, CAPAs, change controls, and KPIs/KQIs. 10-12 years of experience in the pharmaceutical industry, including 5-10 years in GCP Quality and 5+ years supervising GCP Quality internal staff and/or external consultants.

New!

San Carlos, California3 days ago

$300,000–$350,000 Per Year

The Executive Director, Quality Assurance, External Manufacturing is responsible for leading the External Manufacturing Quality function and executing the quality strategy across Vaxcyte’s global network of Contract Development and Manufacturing Organizations (CDMOs) and external partners. This leader drives a proactive, risk-based quality approach and implements scalable systems, governance, and partnerships to enable operational excellence across the external network, supporting clinical development, BLA readiness, and commercial supply.

South San Francisco, CA11 days ago

$200,000–$270,000 Per Year

By offering trust, flexibility, and autonomy through programs like NovoLife, our flexible benefits framework, we empower team members to create an effective work-life balance that delivers professional satisfaction and maximum results for clients. As a globally recognized leader in clinical research and scientific advisory services, we are proud to combine our position at the forefront of the industry with an award-winning workplace culture that values ambition, innovation, and growth.

Menlo Park, CA16 days ago

$213,000–$240,000 Per Year

Review and approve GMP documentation, including master batch records, executed batch records, analytical methods, specifications, validation protocols and reports, tech transfer documentation, stability protocols and reports, and risk-assessment documentation. Oruka's mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year.

Redwood City, California30+ days ago

The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. The Director, Good Laboratory Practice Quality Assurance (GLP QA) is responsible for ensuring Good Laboratory Practices (GLP) compliance at RevMed and external vendors contracted to perform regulated work on behalf of RevMed including all GLP vendors.

Foster City, CA30+ days ago

$190,000–$205,000 Per Year

10-12 years of experience in the pharmaceutical industry, including 5-10 years in GCP Quality and 5+ years supervising GCP Quality internal staff and/or external consultants. Provide quality oversight for the GCP/GVP/GLP vendor activities, including internal/external deviations, CAPAs, change controls, and KPIs/KQIs.

Redwood City, CA30+ days ago

$186,000–$233,000 Per Year

The company's RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.

Redwood City, California30+ days ago

The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.

New!

South San Francisco, CA5 days ago

$215,600–$266,300 Per Year

The Director, CMC QA will report to the Senior Director of CMC QA and be responsible for maintaining strategic responsibility over QA Manufacturing Operations, developing and implementing Ultragenyx CMC Quality approach for assigned programs, and working with colleagues to improve processes utilized to ensure product quality. In this role, in collaboration with key stakeholders in Technical Operations, DIR CMC QA provides quality oversight and support to ensure clinical through commercial development lifecycle activities for drug substance and drug product meet cGMP regulatory requirements and guidelines.

New!

Alameda, CA5 days ago

$190,000–$269,000 Per Year

Acts as the Subject Matter Expert for current global regulatory compliance expectations and proactively reviews changes in regulatory requirements and industry environment that would necessitate future changes and drives completion of impact assessments. Responsible for setting the strategic plan for maintaining organizational inspection readiness across the organization and developing an annual inspection readiness plan, ensures activities are completed, and drives continuous improvement initiatives.

San Ramon, CA30+ days ago

$195,000–$230,000 Per Year

Working closely with QA engineers, mobile developers, backend teams, product management, and support organizations, the QA Manager ensures that testing approaches reflect real-world enterprise usage and release risks. Today, we are a global team of nearly 7,000 and our main objective is to create opportunities for our team members to explore, learn, and grow - all while seeing their ideas come to life and celebrating the differences that make us who we are and the work we do possible.

Redwood City, CA30+ days ago

$211,000–$264,000 Per Year

The company's RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. The Opportunity: The Associate Director (AD) Good Laboratory Practice Quality Assurance (GLP QA) is responsible for ensuring Good Laboratory Practices (GLP) compliance at RevMed and external vendors contracted to perform regulated work on behalf of RevMed including all GLP vendors.

South San Francisco, CA30+ days ago

$275,000–$325,000 Per Year

The companys platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available superior small molecule medicines that overcome current limitations of biologic and peptide drugs. The scope of this strategic role covers both sponsor and outsourced activities of clinical trials, developing a high-performing team of GCP experts, and fostering an understanding and importance of GCPs across the company, ensuring patient safety and data integrity.

alameda, CA30+ days ago

$153,500–$217,000 Per Year

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: Bachelor's degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 11 years of relevant experience; or, Master's degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 9 years of relevant experience; or, PhD degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 5 years of relevant experience; or, Equivalent combination of education and experience. This leader provides insight and partners with both GCP QA staff and Clinical Operations Quality Management (OQM) to address day-to-day clinical trial operations activities focused on deviations, investigations, audit findings and CAPAs.

Alameda, CA30+ days ago

$185,000–$263,000 Per Year

The GCP/GVP QA Director is accountable for Good Clinical Practices (GCP) and Good Pharmacovigilance Practices (GVP) systems and activities, drives compliance and continuous improvement, ensures that Quality is integrated throughout GCP/GVP processes, supports internal/external audits, implements Quality Risk Management (QRM), tracks and trends key metrics, and ensures clinical data integrity. EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education: BS/BA degree in related discipline and a minimum of 13 years of related experience; or, MS/MA degree in related discipline and a minimum of 11 years of related experience; or, PhD in related discipline and a minimum of 8 years of related experience; or, Equivalent combination of education and experience.

Palo Alto, CA25 days ago

$235,000–$285,000

We are looking for an enthusiastic and talented Chemistry, Manufacturing, and controls (CMC) -Good Manufacturing Practice (GMP) Quality Assurance candidate (CMC-GMP QA) who is experienced in the current good manufacturing practices (cGMP) related quality assurance, and who thrive on challenges and changes of Chemistry, Manufacturing and Controls area, who can roll up their sleeves, put on multiple hats and have a can-do attitude without a lot of oversight or instruction. The ideal FTE candidate would have been in a Senior Director/Director of GMP Quality Assurance position and experience from a prior Pharmaceutical or Biotech company with strong records of accomplishments in quality management system, quality assurance, quality audits, pre-approval and GMP inspections and quality assurance aspects for small molecule or biological .

Alameda, CA30+ days ago

Integrates quality by design throughout functional and cross-functional GCP and GVP processes, and a risk-based approach to associated audits; supports cross-functional Quality Risk Management (QRM) processes to identify, track, and mitigate risk within GCP/GVP, develops, tracks, and trends key metrics to inform risk-based decisions, and collaborates with functional representatives to manage patient safety and clinical data integrity and reliability risks through support of functions and QA oversight activities. In addition, this position drives GCP/GPV Inspection Readiness initiatives internally and serves as the coordinator for the Inspection Readiness Governance Council (IRGC), partners with clinical study teams and CROs to conduct inspection preparation activities at Clinical Sites, and collaborates with Compliance QA on the conduct of GCP/GVP mock inspections, internal, and clinical site audits.

San Carlos, CA30+ days ago

$211,000–$246,000 Per Year

The Director will serve as a key quality leader, influencing cross-functional stakeholders and external partners, while driving continuous improvement, risk-based decision-making, and operational excellence across the vendor ecosystem. Summary: The Director, Quality Assurance - Vendor Management is responsible for executing the global vendor quality strategy to ensure compliance, scalability, and inspection readiness across Vaxcyte's GxP supplier network.

Cupertino, CA30+ days ago

Develop and implement scalable QA protocols - including sampling strategies, inter-annotator agreement measures, and error taxonomy frameworks - to ensure consistent, high-quality labeled data. As Senior Manager of QA for Data Annotation, you will own the end-to-end quality assurance strategy for annotation pipelines that feed directly into Apple's AI and machine learning models.

san jose, CA30+ days ago

$140,000–$165,000 Per Year

Oversight of managing and improving site supplier quality Be an advocate for lean and six sigma manufacturing principles and drive continuous improvement Drive cross functional projects with manufacturing, supply chain, and engineering to verify and validate existing manufacturing processes and capabilities Coordinate development of Quality Plan and participate in Design for Manufacturability (DFM) reviews for new customer on-boarding Address process yields by driving cross-functional teams to develop and implement corrective actions utilizing a methodical approach (DMAIC) to root cause and continuous improvement. Recognized as a technology leader, Sanmina Corporation provides end-to-end manufacturing solutions, delivering superior quality and support to Original Equipment Manufacturers (OEMs) primarily in the communications networks, defense and aerospace, industrial and semiconductor systems, medical, multimedia, computing and storage, automotive and clean technology sectors.

San Leandro, CA22 days ago

$116,000–$147,000 Per Year

Kindred Hospital San Francisco Bay Area is a 99-bed long-term acute care hospital offering the same in-depth care you would receive in a traditional hospital, but for an extended recovery period. Maintains oversight responsibility for all regulatory body surveys, including The Joint Commission (TJC), State Licensing Reviews, and CMS Validation surveys.

New!

San Mateo, CA2 days ago

Work with QA/QC responsible person and the Project Executive to compile checklist of hot points applicable to assigned projects (Glazing, EIFS, Roofing System, Wall Systems, Water Proofing, Sealants, Metal Panel Systems, and Swimming Pools). Management of Quality Assurance/Quality Control Staff Work in conjunction with the regional Operations Manager in conducting annual performance reviews for QA/QC personnel establishing meaningful goals and an accurate reflection of their performance.

San Jose, California30+ days ago

$190,000–$230,000 Per Year

Driven by a belief that infectious disease diagnosis should be quick, accurate, and accessible to all, Visby has developed the world’s first single-use PCR platform that disrupts the traditional model and redefines the way infectious disease is tested and treated.$190,000 You will lead and participate in all aspects of the quality management system (QMS) and work closely with cross-functional teams to drive continuous improvement and maintain compliance with the QMS throughout the product lifecycle.

New!

Menlo Park, CA3 days ago

Remote

Antheia is seeking an experienced and driven Associate Director of Global Quality to provide hands-on quality leadership across our regulated starting material (RSM) and pharmaceutical active pharmaceutical ingredient (API) operations. Maintain current knowledge of evolving GMP regulations, ICH guidelines, and DEA requirements relevant to controlled substance API and RSM manufacturing; communicate changes and impact assessments to leadership.

San Carlos, CA30+ days ago

$151,000–$176,000 Per Year

Summary: Vaxcyte is seeking a Manager, Quality Assurance, Compliance who is responsible for providing day-to-day operational oversight governance and strategic oversight of key Quality System processes, with a primary focus on leading Change Control governance and deviation/investigation oversight review board leadership. The Manager acts as an operational backbone a governance leader for cross-functional quality processes, proactively identifying systemic risks, ensuring procedural compliance, driving performance through KPIs, and presenting quality system health and trends through Management Review.

New!

San Carlos, California3 days ago

$151,000–$176,000 Per Year

Vaxcyte is seeking a Manager, Quality Assurance, Compliance who is responsible for providing day-to-day operational oversightgovernance and strategic oversight of key Quality System processes, with a primary focus on leading Change Control governance and deviation/investigation oversightreview board leadership. The Manager acts as an operational backbonea governance leader for cross-functional quality processes, proactively identifying systemic risks, ensuring procedural compliance, driving performance through KPIs, and presenting quality system health and trends through Management Review.

Pleasanton, CA30+ days ago

Reporting to the Head of Quality and Regulatory, the Quality Assurance Manager will play a pivotal role in defining, developing and implementing the lab's quality infrastructure, ensuring compliance with CLIA, CAP, and state (including California and New York) requirements. • Clinical Quality Framework Establishment and Oversight Implement document control, deviation/CAPA systems, training programs, and internal audit processes compliant with CLIA, CAP, and applicable state and federal regulations.

Brisbane, CA30+ days ago

$140,000–$190,000 Per Year

Vera Therapeutics' lead product candidate is atacicept, a fusion protein self-administered at home as a subcutaneous once weekly injection that blocks both B-cell Activating Factor (BAFF) and A Proliferation-Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy (IgAN) and lupus nephritis. Vera Therapeutics' receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Vera Therapeutics and such organization and will be considered unsolicited and Vera Therapeutics will not be responsible for related fees.

San Carlos, CA30+ days ago

This role leads batch disposition, reviews critical GMP documentation, supports PPQ activities, and collaborates cross-functionally to resolve complex manufacturing and quality issues. Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked.

New!

San Carlos, California3 days ago

$151,000–$176,000 Per Year

San Jose, CA30+ days ago

$180,000–$265,000 Per Year

Business Acumen: Able to apply knowledge of business functions, processes and strategies to provide services, solutions and advice that considers and improves the organization as a whole as evidenced by: Ability to understand core business operations/structure of various businesses. Written pre-approval by the Client Service Assurance Partner and the Practice Region RTD and RBLL and the Practice Office OBLL for the specific assignment before a Director may perform duties of Engagement Director of that specific assignment.

Pleasanton, CA16 days ago

$88,700–$165,900 Per Year

Your role at Clorox: As a Scientist II in Global Stewardship / Regulatory, you will be part of the Quality Assurance Unit (QAU) with responsibility for Good Laboratory Practice (GLP), working with a cross functional team to generate quality data and documentation for business critical Regulatory submissions to the US Environmental Protection Agency (EPA). A QAU exists to assure management that facilities, personnel, practices and records are in compliance with regulations, to maintain a master schedule sheet of studies, to inspect each study at intervals to assure compliance and to report findings to Study Director, Study Sponsors and Management.

CA30+ days ago

Private Cloud Director is designed for the experienced infrastructure team, offering a familiar GUI experience for managing VMs and containers, seamless integration with your existing hardware and third-party storage, and critical enterprise features (HA/DR, scale, reliability) built-in. With over 30,000 nodes in production at some of the world's largest enterprises, including Cloudera, EBSCO, Juniper Networks, and Rackspace, Platform9 is the proven path to achieving true vendor independence and operational consistency.

Silicon Valley, CA30+ days ago

$134,000–$348,500 Per Year

The AI Solutions Engineering Delivery Lead will oversee multiple multidisciplinary teams consisting of data scientists, software engineers, front-end developers, and other specialists in the design, development, deployment, monitoring, and maintenance of full-stack AI solutions. Those in data science and machine learning engineering at PwC will focus on leveraging advanced analytics and machine learning techniques to extract insights from large datasets and drive data-driven decision making.

South San Francisco, CA30+ days ago

$193,638–$224,270 Per Year

The Associate Director, GCP Clinical Quality will play a key role in ensuring the successful execution of Denali's clinical trials by delivering strategic quality oversight and fostering a culture of compliance and continuous improvement. Key Accountabilities/Core Job Responsibilities: Serve as a GCP Quality team member on Study Execution Teams (SETs) and deliver a cohesive strategic GCP framework across Denali clinical trials.

New!

San Mateo, CA2 days ago

$190,000–$205,000 Per Year

Oversee system configuration, user acceptance testing (UAT), and validation activities (e.g., CSV/CSA) to ensure the system is fit for intended use and compliant with global GMP regulations. Demonstrated ability to successfully interact with regulatory health authorities at inspections and thorough understanding of audit and vendor management programs.

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Director Of Quality Assurance Jobs in San Jose, CA

Manager/ Director of Quality Assurance CRYSTAL PHARMATECH INC

Senior Director of Quality Assurance Jones Lang LaSalle Inc

Director of Quality Assurance GeneFab

Senior Director of Technical QA (GMP) Summit Therapeutics

Senior Director/Executive Director, Head of GCP Quality Assurance Nkarta, Inc.

Senior Director of Technical QA GMP Summit Therapeutics Inc

Director, Quality Assurance Insitro Inc

Director, Clinical Quality Assurance - Contractor Alumis Inc

Executive Director, GCP QA Good Clinical Practice, Quality Assurance Revolution Medicines Inc

Executive Director, GCP QA (Good Clinical Practice, Quality Assurance) Revolution Medicines

Quality Assurance Director / Sr. Director GVP/PV BridgeBio Pharma Inc

Associate Director, QA Computer System Validation Cytokinetics Inc

Director, Clinical Quality Assurance Corcept Therapeutics Inc

Associate Director, Computer Systems Assurance Quality Nurix Therapeutics Inc

Associate Director, GCP QA Mirum Pharmaceuticals

Executive Director Quality Assurance, External Manufacturing Vaxcyte

Senior Director Quality Assurance Novotech Health Holdings Pte Ltd

Director, GMP Quality Assurance Oruka Therapeutics Inc

Director, GLP Quality Assurance Revolution Medicines

Associate Director, GCP QA Mirum Pharmaceuticals Inc

Associate Director, Clinical Quality Assurance Revolution Medicines Inc

Associate Director, Clinical Quality Assurance Revolution Medicines

Director External Quality Assurance Ultragenyx Pharmaceutical Inc

Compliance QA Director Exelixis Inc

Senior Director, Quality Assurance Engineering PTC Inc

Director, GLP Quality Assurance Revolution Medicines Inc

Executive Director, Global GCP QA Structure Therapeutics Inc

Associate GCP/GLP QA Director Exelixis Inc

GCP/GVP QA Director Exelixis Inc

Senior Director / Director - CMC/GMP Quality Assurance Semnur, Inc.

Executive Director, GCP Quality Assurance Exelixis Inc

Director, Quality Assurance - Vendor Management Vaxcyte Inc

Senior Manager of Quality Assurance, AIML Data Operations Apple Inc

Regional Director of Quality Engineering Sanmina Corp

Director of Quality Management Full Time Knight Health Holdings LLC

Director of Safety and Quality in Construction s j amoroso construction

Director of Quality Visby Medical

Associate Director of Global Quality Antheia

Manager, Quality Assurance, Compliance Vaxcyte Inc

Manager, Quality Assurance, Compliance Vaxcyte

Quality Assurance Manager - CLIA/CAP Laboratory 10X Genomics Inc

Senior Manager, Quality Assurance Vera Therapeutics Inc

Manager, Quality Assurance, External Manufacturing Vaxcyte Inc

Manager, Quality Assurance, External Manufacturing Vaxcyte

Assurance Director bdo consulting

GLP Quality Assurance Specialist The Clorox Co

MTS/SMTS - QA Engineer Platform9 Systems Inc

Digital Assurance & Transparency - Responsible AI - Director PricewaterhouseCoopers LLP

Associate Director, Clinical Quality Denali Therapeutics Inc

Associate Director, Quality System, QMS Mirum Pharmaceuticals

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