171 quality director jobs at 117 companies in Berkeley, CA
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Director, Quality (Clinical)
San Francisco, California, United States
$195k-$230k/yrHybridFull Time
Braveheart Bio: Develops therapies for hypertrophic cardiomyopathy and cardiovascular disease.
10+ YOEBachelor's in life/health sciences required; 10+ years GxP quality experience with deep GCP oversight for global clinical development; experience with audits, vendor/CRO oversight, inspection readiness, computerized system validation, and strong communication and risk assessment skills.
Gilead SciencesNASDAQ: GILD: Develops and sells medicines for life-threatening infectious diseases.
10+ YOELead global product quality complaints program as Global Process Owner; ensure compliant complaint handling, investigation oversight, trending, regulatory reporting, inspection readiness. 10+–12+ years quality experience in pharma/devices and a relevant science or advanced degree required/desired.
Annexon BiosciencesNASDAQ: ANNX: Develops therapies for complement-mediated neuroinflammatory and autoimmune diseases.
10+ YOE5+ MgmtBachelor's in a related field; 10+ years GxP quality systems experience in biologics/pharma; expertise in CSV/CSA, Veeva Vault Quality; strong regulatory knowledge.
Arcadia or Sacramento or San Francisco or Campbell or Pasadena
$114k-$140k/yrHybridFull Time
Pacific Clinics: Provides comprehensive behavioral health care and social services.
5+ YOEBachelor's in mental/behavioral health; 5 years healthcare experience with at least 1 year implementing utilization review or quality assurance; knowledge of Quality Improvement processes and Medi-Cal regulations.
QuantumScapeNYSE: QS: Develops next-generation solid-state batteries for electric vehicles.
12+ YOE3+ MgmtBS in engineering/materials/chemistry required,12+ years quality experience with 3+ years supplier quality leadership, APQP/PPAP/FMEA/SPC/MSA/8D expertise, lean experience, supplier audits and corrective action skills.
Gilead SciencesNASDAQ: GILD: Develops and sells medicines for life-threatening infectious diseases.
10+ YOEGlobal complaints process ownership with 10+ years in quality/regulatory in pharma or devices, strong cGMP/regulatory knowledge, inspection experience, statistical trending, process improvement, and people leadership.
Attovia Therapeutics: Creates biotherapeutics for treating immune-mediated diseases and oncology.
12+ YOE12+ years QA experience in biotech with CDMO/CRO oversight, strong GMP/GCP/GLP knowledge, vendor auditing, quality agreement negotiation, batch record review; bachelor’s degree in life science/chemistry/engineering.
San Francisco or Arizona or California or Colorado or Florida or Georgia or Iowa or Idaho or Illinois or Indiana or Massachusetts or Michigan or Missouri or North Carolina or New Hampshire or New Jersey or New York or Ohio or Oklahoma or Oregon or Pennsylvania or South Carolina or Tennessee or Texas or Utah or Virginia or Washington or Wisconsin or West Virginia
$160k-$190k/yrRemoteFull Time
Phil: Streamlines prescription access and management for patients and pharmacies.
10+ YOE5+ Mgmt10+ years in operational quality or quality engineering, 5+ years scaling quality functions, experience with software quality and AI/LLM monitoring, bachelor\u0002s degree or equivalent experience, strong data-driven problem solving, ability to travel up to 20%.
Applied MaterialsNASDAQ: AMAT: Manufacturers of equipment for semiconductor and display production.
Executive leader for quality management of EPIC fab/lab operations; requires semiconductor fab or lab experience, QMS and ISO familiarity, global quality interfaces, team leadership, and ability to drive corrective actions.
Revolution MedicinesNASDAQ: RVMD: Developing precision oncology therapies for RAS-addicted cancers
10+ YOEBachelor's in a scientific/engineering/technical discipline; 10+ years GMP quality experience with validation (PPQ, CPV, cleaning, packaging, transportation); experience with CMOs, regulatory inspections, and risk-based decision making.
electronic quality systems, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook, Microsoft Visio
Astra: Manufacturer of orbital launch vehicles and satellite propulsion systems.
10+ YOE10+ years in aerospace/defense quality and mission assurance; Bachelor's in engineering or related technical field; proven QMS and leadership in a manufacturing/startup; AS9100/NAS/DoD familiarity.
10+ YOEProvide strategic leadership of QC and stability programs, oversight of external contract labs, author stability sections for regulatory filings; 10+ years QC pharma experience and advanced degree preferred.
5+ YOEBachelors in pharmaceutical sciences or related field, 5+ years regulated-industry experience, quality management system and cGMP experience, knowledge of validation, tech transfer, audits, and regulatory submissions.
AbbottNYSE: ABT: Manufactures medical devices, diagnostics, and nutritional health products.
12+ YOEBachelor's degree,12+ years healthcare regulatory/compliance and quality systems experience with people leadership; experience with QMS,CAPA,Joint Commission,CMS,state licensing; strong analytical and communication skills.
Mirum PharmaceuticalsNASDAQ: MIRM: Develops and commercializes therapies for rare liver diseases.
12+ YOE12+ years in Quality/Quality Systems in drug development; experience with electronic QMS (ideally Veeva Vault QMS); strong PM/Change mgmt; SOP writing; audit support; cross-functional collaboration.
Thermo Fisher ScientificNYSE: TMO: Sells equipment and chemicals for scientific research and healthcare.
10+ YOEBachelor's in Science/Engineering, 10+ years medical device industry experience, expert QMS knowledge (21 CFR Part 820, ISO 13485, MDSAP), multi-site quality operations, Lean/Six Sigma training, TrackWise/AGILE/E1/SAP/LIMS familiarity; travel up to 30%.
7+ YOE3+ MgmtBachelor's in life sciences/biotech/engineering, 7+ years in quality with 3+ years leadership in biotech/diagnostics; experience with design control, DHF, supplier/CDMO quality, QMS, CAPA, change control, risk management (FMEA); strong cross-functional leadership.
Quality Management System (QMS), Design History File (DHF), SOPs, CAPA, CoAs, SCARs, FMEA, ISO 13485, FDA 21 CFR Part 820 (QSR/QMSR), GMP, CE IVD, UL
Allogene TherapeuticsNASDAQ: ALLO: Develops allogeneic cell therapies for cancer and autoimmune diseases
7+ YOE7+ years biopharma experience with manufacturing oversight, BS in engineering/chemistry/biological sciences required (advanced degree preferred), ASQ certifications preferred, strong knowledge of US FDA GMP/EMA/ICH, inspection leadership, and MS Office proficiency.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Visio, Microsoft Project, statistical software