11 qa director jobs at 8 companies in San Marcos, CA
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Director, QA - Product Development Processes
San Diego, California, United States
$164k-$274k/yrHybridFull Time
DexcomNasdaq: DXCM: Manufacturer of continuous glucose monitoring systems for diabetes management.
13+ YOE8+ MgmtBachelor’s degree in a technical discipline preferred, 13+ years of medical device development experience, and 8–9+ years of progressive leadership or management experience. Expertise in Design Control, Risk Management, CAPA, audits, and quality systems required.
Continuous Glucose Monitoring (CGM), ISO 14971, IEC 60812, FDA QMSR, ISO 13485, Value Stream Mapping, Business Process Mapping, Corrective and Preventive Action (CAPA), Quality Management System (QMS), Design Control, Risk Management, Software Development Lifecycle (SDLC)
Viking TherapeuticsNASDAQ: VKTX: Develops therapies for metabolic and endocrine disorders.
10+ YOE5+ MgmtBachelor's in life sciences or engineering, 10+ years QA experience with 5+ years in leadership; deep GMP/FDA/ICH knowledge, eQMS (Veeva) experience, QRM, audit and inspection readiness.
Travere TherapeuticsNASDAQ: TVTX: Developing and selling therapies for rare kidney diseases.
10+ YOEBachelor's in life science,10+ years FDA-regulated QA experience,experience managing teams,cGMP knowledge,validation and vendor oversight,MS Office proficiency,ability to travel 10-25%.
Microsoft Word, Microsoft Excel, Adobe, Microsoft PowerPoint
DanaherNYSE: DHR: Develops scientific instruments and diagnostic tools for healthcare markets.
10+ YOE6+ MgmtBachelor's in science/engineering (or Master's/Doctorate) with extensive executive experience (18–20+ yrs), 10+ years quality leadership in IVD/medical device, 6+ years people leadership, deep QA/QC/process validation and regulatory (FDA/ISO) knowledge.
Danaher Business System (DBS), Quality Management System (QMS)
ADARx Pharmaceuticals: Develops RNA-targeting therapeutics for treating genetic and cardiometabolic diseases.
10+ YOE10+ years GCP QA experience in biotech/pharma, experience with late-stage trials and inspection readiness; bachelor's in life sciences/pharmacy required; advanced degree preferred; strong leadership and communication skills.
Artiva BiotherapeuticsNASDAQ: ARTV: Develops allogeneic natural killer cell-based therapies for various diseases.
15+ YOE8+ Mgmt15+ years GMP QA experience in biologics/cell therapy with 8+ years senior quality leadership, bachelor's degree required, deep knowledge of 21 CFR/ICH regs, inspection and BLA experience.
ErascaNASDAQ: ERAS: Developing precision oncology medicines to treat cancer patients.
12+ YOE12+ years in GCP quality with regulatory inspection experience; demonstrated leadership in clinical QA, knowledge of ICH GCP and global regulations, ability to manage audits, CAPAs, and mentor staff.
ErascaNASDAQ: ERAS: Developing precision oncology medicines to treat cancer patients.
8+ YOEBachelor of Science or equivalent required; advanced degree preferred. Requires 8–10 years in GxP pharmaceutical environments, including at least 8 years of GMP QA, solid oral dosage and biologics manufacturing, and FDA inspection experience.
electronic document management systems, Quality Management System software platforms
Artiva BiotherapeuticsNASDAQ: ARTV: Develops allogeneic natural killer cell-based therapies for various diseases.
8+ YOEBS/BA in a scientific field,8+ years clinical/QA experience,4+ years clinical QA,knowledge of ICH-GCP/GCLP/CLIA/CAP,FDA regs,inspection and audit experience,Microsoft Word/Project/Excel skills.
Microsoft Word, Microsoft Project, Microsoft Excel
Travere TherapeuticsNASDAQ: TVTX: Developing and selling therapies for rare kidney diseases.
8+ YOEBachelors in life science,8+ years analytical experience in drug/biologics development with GMP QA and analytical validation expertise; knowledge of cGMP/ICH/FDA; ability to support audits and regulatory submissions; travel up to 10-20%.