QA Testing Director /Manager/SME Tanisha SystemsQA Testing Director /Manager/SMESanta Clara, CAFull timeWhat Success Looks Like / Expected Outcome –– Success in this role means establishing a unified, automation-first QA strategy that is consistently applied across programs, with Cypress frameworks fully integrated into CI/CD pipelines to deliver reliable regression, API, and integration coverage while reducing manual effort; quality metrics and dashboards drive leadership decisions with defect leakage reduction, cross-functional teams align on clear quality objectives embedded into sprint planning and release cycles, multiple strategic initiatives achieve on-time, defect-minimized releases, QA engineers are mentored into automation-first practitioners with elevated skills in Cypress, TypeScript, and API testing, and proactive risk identification and mitigation practices are embedded to ensure business programs progress without major quality-related disruptions and increase in AI adoption. 10 years in Quality Engineering & Test Architecture – Automation testing with Cypress & Typescript, Performance & scalability testing, CI/CD, API/UI, Microservices, test data, and non-functional testing.
Director Of Quality Assurance VitalConnectDirector Of Quality AssuranceSan Jose, CA$200,000–$230,000 / yearAdditionally, this position will be responsible for documentation control, receiving and in-process inspection, finished product release, calibration, preventive maintenance, employee training and other quality initiatives. The estimated hiring salary range for this position is $200,000 - $230,000 * The actual salary will be based on a variety of job-related factors, including geography, skills, education and experience.
Director of Quality Assurance VitalConnect IncDirector of Quality AssuranceSan Jose, CA$200,000–$230,000 / yearAdditionally, this position will be responsible for documentation control, receiving and in-process inspection, finished product release, calibration, preventive maintenance, employee training and other quality initiatives. The estimated hiring salary range for this position is $200,000 - $230,000 * The actual salary will be based on a variety of job-related factors, including geography, skills, education and experience.
Senior Director/Executive Director, Head of GCP Quality Assurance Nkarta, Inc.Senior Director/Executive Director, Head of GCP Quality AssuranceSouth San Francisco, CA$250,000–$340,000 / yearNkarta 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.
Director, Quality Assurance InsitroDirector, Quality AssuranceSouth San Francisco, CA$205,000–$218,000 / yearWe 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.
Director Quality Assurance Imperative Care IncDirector Quality AssuranceCampbell, CA$234,000–$244,000 / yearWhat You'll Bring: Bachelor's degree in engineering or related discipline and a minimum of 10 years of progressive responsibility in quality assurance in a medical device, regulated or robotics setting, plus a minimum of 3 years of prior people management experience; or equivalent combination of education and work experience. As a key leader, this role takes part of strategic conversations and activities that include building a quality infrastructure aimed at transferring operations from concept to manufacturing in collaboration with robotics upper management and consultants.
Director Quality Assurance Imperative CareDirector Quality AssuranceCampbell, CA$234,000–$244,000 / yearWhat You'll Bring: Bachelor's degree in engineering or related discipline and a minimum of 10 years of progressive responsibility in quality assurance in a medical device, regulated or robotics setting, plus a minimum of 3 years of prior people management experience; or equivalent combination of education and work experience. As a key leader, this role takes part of strategic conversations and activities that include building a quality infrastructure aimed at transferring operations from concept to manufacturing in collaboration with robotics upper management and consultants.
Director, Clinical Quality Assurance - Contractor Alumis Inc.Director, Clinical Quality Assurance - ContractorSouth San Francisco, CA$193,000–$242,000 / yearThe 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.
Director, Quality Assurance Insitro IncDirector, Quality AssuranceSouth San Francisco, CA$205,000–$218,000 / yearWe 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.
Senior Director / Director, Quality Assurance Attovia TherapeuticsSenior Director / Director, Quality AssuranceSan Carlos, CA$210,000–$280,000 / yearReporting directly to the Quality Officer, this role is responsible for vendor quality management: qualifying and auditing CDMOs/CROs, negotiating and maintaining Quality Agreements, performing final quality review for batch release and lot disposition, and ensuring the company's internal Quality Management System (QMS) ties together all outsourced activity into a single, inspection-ready compliance picture. Working across internal functions and with external clinical/nonclinical QA consultants, drive the development of the internal QMS, including SOPs governing vendor oversight, deviations, CAPA, change control, document control, clinical operations, data management, pharmacovigilance, biostatistics, and training, and continuously improve it to support scaling clinical pipelines.
Quality Assurance Director / Sr. Director GVP/PV BridgeBio Pharma IncQuality Assurance Director / Sr. Director GVP/PVSan Francisco, CAFounded 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.
Executive Director, GCP QA (Good Clinical Practice, Quality Assurance) Revolution Medicines, Inc.Executive Director, GCP QA (Good Clinical Practice, Quality Assurance)Redwood City, CA$265,000–$331,000 / yearThe 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).
Senior Director / Director, Quality Assurance Attovia Therapeutics IncSenior Director / Director, Quality AssuranceSan Carlos, CA$210,000–$280,000 / yearReporting directly to the Quality Officer, this role is responsible for vendor quality management: qualifying and auditing CDMOs/CROs, negotiating and maintaining Quality Agreements, performing final quality review for batch release and lot disposition, and ensuring the company''s internal Quality Management System (QMS) ties together all outsourced activity into a single, inspection-ready compliance picture. Working across internal functions and with external clinical/nonclinical QA consultants, drive the development of the internal QMS, including SOPs governing vendor oversight, deviations, CAPA, change control, document control, clinical operations, data management, pharmacovigilance, biostatistics, and training, and continuously improve it to support scaling clinical pipelines.
Executive Director, GCP QA Good Clinical Practice, Quality Assurance Revolution Medicines IncExecutive Director, GCP QA Good Clinical Practice, Quality AssuranceRedwood City, CA$265,000–$331,000 / yearThe 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).
Executive Director, GCP QA (Good Clinical Practice, Quality Assurance) Revolution MedicinesExecutive Director, GCP QA (Good Clinical Practice, Quality Assurance)Redwood City, California$265,000–$331,000 / yearThe 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).
Associate Director, QA Computer System Validation Cytokinetics IncAssociate Director, QA Computer System ValidationSouth San Francisco, CA$184,500–$215,250 / yearThis 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.
Associate Director, GCP QA Mirum PharmaceuticalsAssociate Director, GCP QAFoster City, California$190,000–$205,000 / yearProvide 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.
Director, Clinical Quality Assurance GCP Eikon Therapeutics IncDirector, Clinical Quality Assurance GCPMillbrae, CA$204,000–$246,750 / yearEikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets. Lead quality management system (QMS) assessment for service providers and collaborate closely with Clinical Development Vendor Oversight team to ensure service provider qualification process is robust and timely.
Associate Director / Senior Manager, Quality Assurance AllakosAssociate Director / Senior Manager, Quality AssuranceRedwood City, CaliforniaAssociate Director / Senior Manager, Quality Assurance Allakos Inc. is a clinical-stage company developing therapeutic antibodies for inhibitory receptors on the surface of immune effector cells involved in allergic, inflammatory and proliferative diseases. Position Summary: As a member of the Allakos team you will be responsible for quality oversight activities related to Method Validation, Release testing, and Stability for Drug Substance and Drug Product.
Executive Director, CMC QA Ultragenyx Pharmaceuticals Inc.Executive Director, CMC QASouth San Francisco, CA$294,100–$363,300 / yearThe role will lead and develop a team of approximately 8-12 quality professionals, partner closely with Technical Operations, Product Development, Supply Chain, Regulatory, and Quality stakeholders, and represent CMC QA in governance forums, inspections, regulatory submissions, and external partner interactions. Strong technical understanding of CMC development and manufacturing across multiple modalities such as biologics, small molecules, oligonucleotides, gene therapy, mRNA, enzymes/proteins, or other advanced/novel therapeutics; direct experience with starting materials, drug substance, and drug product preferred.
Director, Clinical Quality Assurance (Cqa) Coherus BiosciencesDirector, Clinical Quality Assurance (Cqa)Redwood City, CA$190,000–$240,000 / yearThe position will also be responsible for supporting and hosting regulatory inspections and defining and implementing clinical compliance plans to include GCP/GCLP/GVP audits of service providers, CROs, investigator sites, bioanalytical laboratories, and Drug Safety and Pharmacovigilance systems and processes. This role is responsible for ensuring that Coherus plans and systems that govern clinical studies are in compliance with regulatory requirements, industry best practices (ie GCP, GLP, GVP) and company SOPs by working with Quality management, external auditors, and other internal Clinical functions.
Executive Director Quality Assurance, External Manufacturing Vaxcyte IncExecutive Director Quality Assurance, External ManufacturingSan Carlos, CA$300,000–$350,000 / yearSummary: 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.
Director QA Systems Contract Adverum Biotechnologies IncDirector QA Systems ContractRedwood City, CALeveraging the research capabilities of its proprietary intravitreal IVT platform, Adverum is developing durable single-administration therapies designed to be delivered in physicians offices to eliminate the need for frequent ocular injections to treat these diseases. Actively partner with cross-functional leadership to address challenges, develop solutions, and execute plans for integration with corporate systems and preparation for commercial stage support.
NewDirector, Quality Assurance Operations Adicet BioDirector, Quality Assurance OperationsRedwood City, CaliforniaAdicet is located in a state-of-the-art facility and works to create an incredible office experience with an onsite gym and various other fitness options, onsite parking with electric vehicle charging stations and free shuttle (Caltrain), company-subsidized lunches (delivered onsite daily) and fully stocked breakrooms. To ensure the wellness of our employees and their loved ones, we offer comprehensive health plans (medical, dental, vision, etc.), Flexible Health and Commuter Spending Accounts (FSA) and a company matched Health Savings Account (HSA).
Associate Director, GCP QA Mirum Pharmaceuticals IncAssociate Director, GCP QAFoster City, CA$190,000–$205,000 / year10-12 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.
Director, Clinical Quality Assurance CQA Coherus Oncology IncDirector, Clinical Quality Assurance CQARedwood City, CA$190,000–$240,000 / yearThe position will also be responsible for supporting and hosting regulatory inspections and defining and implementing clinical compliance plans to include GCP/GCLP/GVP audits of service providers, CROs, investigator sites, bioanalytical laboratories, and Drug Safety and Pharmacovigilance systems and processes. This role is responsible for ensuring that Coherus plans and systems that govern clinical studies are in compliance with regulatory requirements, industry best practices (ie GCP, GLP, GVP) and company SOPs by working with Quality management, external auditors, and other internal Clinical functions.
Executive Director Quality Assurance, External Manufacturing VaxcyteExecutive Director Quality Assurance, External ManufacturingSan Carlos, California$300,000–$350,000 / yearThe 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.
Associate Director, Clinical Quality Assurance Revolution Medicines, Inc.Associate Director, Clinical Quality AssuranceRedwood City, CA$186,000–$233,000 / yearThe 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.
NewSr/Exec Director, Quality Assurance GCP ErascaSr/Exec Director, Quality Assurance GCPSouth San Francisco, CAConduct gap analysis and risk assessment for critical study level activities that may impact subject safety and/or the quality and reliability of data, including but not limited to: Study Design and Protocol Requirements, Clinical Vendors and Service Providers-Transferred Obligations, contractual duties per SOW, and overall performance, Internal processes (e.g., vendor oversight), and Clinical Site and PI assessment and performance. Reporting to the Chief Operating Officer, the Senior or Executive Director Quality Assurance GCP will lead GCP activities and have responsibility for strategic and tactical oversight and implementation of QA GCP operations in support of Erasca's clinical development programs (Phase 1, 2, 3), regulatory submissions, and planned future commercial launches.
Director, GLP Quality Assurance Revolution Medicines IncDirector, GLP Quality AssuranceRedwood City, CA$211,000–$264,000 / yearThe 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 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.
Director, GLP Quality Assurance Revolution MedicinesDirector, GLP Quality AssuranceRedwood City, California$211,000–$264,000 / yearThe 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.
Senior Director, Global GMP Quality Assurance Structure Therapeutics IncSenior Director, Global GMP Quality AssuranceSouth San Francisco, CA$240,000–$300,000 / yearThe company's 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. Position Summary: We are seeking a Senior Director of GMP Quality Assurance (QA) to serve as a senior quality leader responsible for developing, leading, and executing the global GMP QA strategy in support of a transition from clinical development to commercial readiness.
Associate QA Operations Director - Labeling & Systems Exelixis IncAssociate QA Operations Director - Labeling & SystemsAlameda, CA$176,000–$250,500 / yearThe Associate QA Operations Director - Labeling & Systems is accountable for providing QA lead support for Quality Systems (Deviations, Change Control, CAPA, etc.), As a Partner responsible for guiding the organization in the successful, thorough, and timely execution of complex Quality Events (Deviations, Change Requests, CAPA's, CAPA Actions, Change Actions, Effectiveness Checks, etc.). BS/BA degree in Biology, Computer Science, Education, Learning & Development, Sciences, or related discipline and 11 years of related experience; or, MS/MA degree in Biology, Computer Science, Education, Learning & Development, Sciences, or related discipline and 9 years of related experience; or, Equivalent combination of education and experience.
Associate QA Operations Director - Systems And Process Exelixis Inc.Associate QA Operations Director - Systems And ProcessAlameda, CA$176,000–$250,500 / yearThe Associate QA Operations Director - Systems and Process is accountable for providing QA lead support for Quality Systems (Deviations, Change Control, CAPA, etc.), As a Partner responsible for guiding the organization in the successful, thorough, and timely execution of complex Quality Events (Deviations, Change Requests, CAPA's, CAPA Actions, Change Actions, Effectiveness Checks, etc.). BS/BA degree in Biology, Computer Science, Education, Learning & Development, Sciences, or related discipline and 11 years of related experience; or, MS/MA degree in Biology, Computer Science, Education, Learning & Development, Sciences, or related discipline and 9 years of related experience; or, Equivalent combination of education and experience.
Executive Director, CMC QA Ultragenyx Pharmaceutical IncExecutive Director, CMC QASouth San Francisco, CA$294,100–$363,300 / yearThe role will lead and develop a team of approximately 8-12 quality professionals, partner closely with Technical Operations, Product Development, Supply Chain, Regulatory, and Quality stakeholders, and represent CMC QA in governance forums, inspections, regulatory submissions, and external partner interactions. Strong technical understanding of CMC development and manufacturing across multiple modalities such as biologics, small molecules, oligonucleotides, gene therapy, mRNA, enzymes/proteins, or other advanced/novel therapeutics; direct experience with starting materials, drug substance, and drug product preferred.
Director, QA Systems (Contract) Adverum Biotechnologies, Inc.Director, QA Systems (Contract)Redwood City, CALeveraging the research capabilities of its proprietary intravitreal (IVT) platform, Adverum is developing durable, single-administration therapies designed to be delivered in physicians' offices to eliminate the need for frequent ocular injections to treat these diseases. Actively partner with cross-functional leadership to address challenges, develop solutions, and execute plans for integration with corporate systems and preparation for commercial stage support.
Associate Director, Clinical Quality Assurance Revolution Medicines IncAssociate Director, Clinical Quality AssuranceRedwood City, CA$186,000–$233,000 / yearThe 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.
Associate Director, Clinical Quality Assurance Revolution MedicinesAssociate Director, Clinical Quality AssuranceRedwood City, CaliforniaThe 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.
Director, Quality Assurance *PC 586 Miltenyi BiotecDirector, Quality Assurance *PC 586San Jose, California$212,237–$249,690 / yearMiltenyi Bioindustry plays a unique role as both the producer and the service provider, relying on our instruments and reagents for each workflow step, controlling the entire supply chain and thus delivering greater security and planning clarity to our customers. 15 years applicable experience in Technical Operations (preferably manufacturing, QA and/or QC rel. to ATMPs) in the Pharmaceutical, Medical Device, or other Lifescience industry (preferred) with 10+ years in various Quality Assurance leadership roles.
Associate Gcp/Glp QA Director Exelixis Inc.Associate Gcp/Glp QA DirectorAlameda, CA$177,500–$251,500 / yearEDUCATION/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. SUMMARY/JOB PURPOSE: This key role drives consistency across QA systems and processes for the Clinical QA team, identifying issues and risks, escalating in a timely fashion, and aligning metrics that provide input into a compliance scorecard for Clinical programs.
Director, Quality Assurance *PC 586 Miltenyi Biotec GmbHDirector, Quality Assurance *PC 586San Jose, CAThe role provides oversight of QMS maintenance and batch release activities, supplier quality, management of health authority inspections and client audits, technical transfers as well as the support of client commercialization programs. 15 years applicable experience in Technical Operations (preferably manufacturing, QA and/or QC rel. to ATMPs) in the Pharmaceutical, Medical Device, or other Lifescience industry (preferred) with 10+ years in various Quality Assurance leadership roles.
GCP/GVP QA Director Exelixis IncGCP/GVP QA DirectorAlameda, CA$185,000–$263,000 / yearThe 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.
Gcp/Gvp QA Director Exelixis Inc.Gcp/Gvp QA DirectorAlameda, CA$185,000–$263,000 / yearThe 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.
Senior Director / Director - CMC/GMP Quality Assurance Semnur, Inc.Senior Director / Director - CMC/GMP Quality AssurancePalo Alto, CA$235,000–$285,000We 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.
Executive Director, GCP Quality Assurance Exelixis IncExecutive Director, GCP Quality AssuranceAlameda, CAIntegrates 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.
Director, Quality Assurance - Vendor Management Vaxcyte IncDirector, Quality Assurance - Vendor ManagementSan Carlos, CA$211,000–$246,000 / yearThe 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.
Associate Director of Global Quality Antheia IncAssociate Director of Global QualityMenlo Park, CARemoteAntheia 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.
Director of Quality Management Full Time Knight Health Holdings LLCDirector of Quality Management Full TimeSan Leandro, CA$116,000–$147,000 / yearKindred 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.
Associate Director Of Global Quality AntheiaAssociate Director Of Global QualityMenlo Park, CARemoteAntheia 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.
Associate Director of Global Quality AntheiaAssociate Director of Global QualityMenlo Park, CARemoteAntheia 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.