171 quality director jobs at 117 companies in Berkeley, CA

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Director, Quality (Clinical)
San Francisco, California, United States
$195k-$230k/yr HybridFull Time
Braveheart Bio
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.
1mo
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Director, Quality
Foster City or Parsippany or United States
$191k-$272k/yr OnsiteFull Time
Gilead Sciences
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.
3mo
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Director, Quality Systems
Brisbane or United States
$212k-$228k/yr HybridFull Time
Annexon Biosciences
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.
Veeva Vault Quality, CSV, CSA, EDMS, LMS
1mo
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Director, Quality Assurance
Arcadia or Sacramento or San Francisco or Campbell or Pasadena
$114k-$140k/yr HybridFull Time
Pacific Clinics
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.
Electronic Health Record (EHR)
4d
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Director, Supplier Quality
San Jose, California, United States
$179k-$251k/yr OnsiteFull Time
QuantumScape
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.
APQP, PPAP, FMEA, SPC, MSA, 8D, IQC
1mo
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Director, Quality
Foster City or Parsippany
$191k-$272k/yr OnsiteFull Time
Gilead Sciences
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.
6d
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Senior Director / Director, Quality Assurance
San Carlos, California, United States
$210k-$280k/yr OnsiteFull Time
Attovia Therapeutics
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.
Veeva QMS, MasterControl, TrackWise
4w
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Director of Quality Excellence
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/yr RemoteFull Time
Phil
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%.
3mo
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Quality Director Fab Operations EPIC Center
Santa Clara, California, United States
$181k-$249k/yr OnsiteFull Time
Applied Materials
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.
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Associate Director, Quality Validation
Redwood City, California, United States
$186k-$233k/yr HybridFull Time
Revolution Medicines
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
2mo
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Director, Quality
Alameda, California, United States
$212k-$250k/yr OnsiteFull Time
Astra
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.
AS9100, NADCAP, QMS, Risk Management, Reliability Engineering
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Director, Quality Control
Redwood City, California, United States
$215k-$253k/yr OnsiteFull Time
Corcept Therapeutics
Corcept TherapeuticsNASDAQ: CORT: Develops pharmaceutical treatments that regulate cortisol hormone activity.
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.
2w
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Associate Director, Quality Operations
Palo Alto, California, United States
OnsiteFull Time
Kodiak Sciences
Kodiak SciencesNASDAQ: KOD: Developing biopolymer conjugate therapeutics for retinal vascular diseases.
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.
4w
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Director, Quality Assurance *PC 586
San Jose, California, United States
$212k-$250k/yr OnsiteFull Time
Miltenyi Biotec
Miltenyi Biotec: Develops products and services for cell processing and research.
15+ YOE10+ MgmtExtensive QA leadership experience in GMP manufacturing and CMC quality oversight; experience with QMS, inspections/audits, BLA/IND submissions, technical transfers, and regulatory compliance (21 CFR, EU GMP, ICH).
2w
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Director, Quality & Regulatory Affairs
Livermore, California, United States
$172k-$344k/yr OnsiteFull Time
Abbott
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.
Quality Management Systems (QMS)
2mo
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Associate Director, Quality System, QMS
Foster City, California, United States
$197k-$221k/yr HybridFull Time
Mirum Pharmaceuticals
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.
Veeva Vault QMS, GMP regulations, CSV, CSA, SOP writing, Audit support
1mo
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Sr. Director, Quality, Genetics Sciences Division (GSD)
Pleasanton, California, United States
$210k-$280k/yr OnsiteFull Time
Thermo Fisher Scientific
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%.
TrackWise, AGILE, E1/SAP, LIMS, FMEA, RCA
4w
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Senior Manager/Associate Director, Quality
Palo Alto, California, United States
$180k-$215k/yr OnsiteFull Time
Countable Labs
Countable Labs: Develops high-accuracy multiplexed genomics quantification platforms.
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
2mo
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Director, Quality Assurance
South San Francisco, California, United States
$205k-$218k/yr HybridFull Time
insitro
insitro: Decodes biology using machine learning to discover new medicines
10+ YOE10+ years QA in biotech/pharma; GXP mastery; vendor audits; CS validation familiarity; lead QMS development.
1mo
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Associate Director, External Quality
Newark, California, United States
$170k-$210k/yr OnsiteFull Time
Allogene Therapeutics
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