43 qa director jobs at 31 companies in Stoneham, MA
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Sr Director, QA- GxP Systems
Needham, Massachusetts, United States
$258k-$280k/yrHybridFull Time
Candel TherapeuticsNASDAQ: CADL: Develops viral immunotherapies for the treatment of cancer.
10+ YOEBachelor's in life sciences,10+ years biotech/pharma QA with GxP systems, vendor oversight, CSV, audits, and Part 11 compliance; experience with eQMS/EDMS and regulated clinical workflows.
Intellia TherapeuticsNASDAQ: NTLA: Develops curative gene-editing treatments using CRISPR technology.
10+ YOE10+ years industry experience with GMP QC oversight; advanced degree (MS/PhD preferred); experience with stability, reference standards, analytical methods, audits, and regulatory interactions.
EDMS, LIMS, JMP, MINITAB, GraphPad Prism, PLA, HPLC, UPLC, CE
Dyne TherapeuticsNASDAQ: DYN: Developing therapeutics for genetically driven neuromuscular diseases.
8+ YOEBachelor's in engineering/science (Master's preferred), 8+ years in cGMP environment and 5+ years in QA, experience overseeing CMOs/CDMOs, knowledge of FDA/EMA regulations, GxP QA systems, strong communication and decision-making skills.
LonzaSIX Swiss Exchange: LONN: Manufactures medicines and provides development services for healthcare companies.
8+ YOEBachelor's in science/engineering required (MS/PhD preferred); 8+ years QA in biotech/pharma or regulated manufacturing; leadership in GMP environments; strong cGMP, sterile manufacturing, deviations/CAPA/change control experience; TrackWise/LIMS/ELN/SAP exposure.
Rhythm PharmaceuticalsNASDAQ: RYTM: Develops precision medicines for rare neuroendocrine and obesity diseases.
8+ YOE8+ years industry experience with 5+ years GCP QA or clinical trial QA, experience with GCP/GLP/GVP regulations and regulatory inspections, strong communication and project management skills.
Director/Senior Director, QMS, Digital QA and GxP Compliance
Waltham, Massachusetts, United States
$200k-$260k/yrOnsiteFull Time
Crescent BiopharmaNASDAQ: CBIO: Develops novel oncology therapies and antibody-drug conjugates for cancer.
8+ YOEBachelor's degree,8+ years in QMS and digital QA in biotech/pharma,expertise in GxP computerized systems,validation,data integrity,vendor qualification,audit and inspection readiness.
Vertex PharmaceuticalsNASDAQ: VRTX: Develops and sells prescription drugs for serious genetic diseases.
8+ YOEBachelor's in biotech/life sciences required (Master's preferred), typically 8+ years' industry experience in manufacturing/QA/QC for biotech/pharma, strong GxP/cGMP knowledge, deviation/CAPA/root-cause expertise, and electronic QMS experience.
QMS, Trackwise, Veeva, cGMP, GXP, LEAN, DMAIC, Six Sigma
Little People's College: Operates early education and childcare centers for young children.
5+ YOE3+ MgmtEEC Director I certification; Bachelor's in Early Childhood Education or related field (preferred); 5 years licensed ECE; 3 years leadership; licensing/QA experience desirable.
Nova Biomedical: Develops and manufactures blood testing analyzers and diagnostic equipment.
12+ YOE12+ Mgmt12+ years medical device/diagnostic QA experience with 12+ years managing quality teams; strong GMP, QMS, CAPA, audits, root cause analysis, validation, supplier and training oversight.
Electric Hydrogen: Manufactures industrial-scale electrolyzers for cost-effective green hydrogen production.
10+ YOEBachelor's in engineering or related field, 10+ years in quality or manufacturing quality, experience building QMS and achieving ISO 9001, supplier quality management, leadership across QA/QC/QMS, data-driven problem solving; relevant quality certifications preferred.
Solid BiosciencesNASDAQ: SLDB: Develops precision genetic medicines for neuromuscular and cardiac diseases.
10+ YOE3+ MgmtRequires a science-related bachelor's degree or equivalent experience, 10–15 years of biotech technical QA experience, 3+ years leading outsourced activities, GMP expertise, biologics experience, and regulatory inspection experience.
AgenusNASDAQ: AGEN: Developing immuno-oncology therapies and vaccines to treat cancer.
10+ YOEBachelor's in a scientific discipline,10+ years QA experience in biotech/pharma, GMP/GCP/GLP expertise, eQMS experience, CMO oversight, inspection readiness, and leadership skills.
Bristol Myers SquibbNew York Stock Exchange: BMY: Develops and distributes innovative medicines for serious diseases.
12+ YOEBachelor's in Engineering/IT/Computer Science, 12+ years in pharmaceutical quality/CSV/IT compliance, leadership experience, expertise in 21 CFR and GAMP, QA and validation knowledge, strong technical writing and problem-solving skills.
Catalent: Global provider of drug development and manufacturing solutions.
10+ YOEBachelor's in chemistry/biology required, master's preferred; 10+ years leading QA/QC in pharmaceutical GMP; regulatory inspection experience; knowledge of change management and Lean; leadership and budget management skills.
Lean, Good Manufacturing Practice (GMP), GEA Niro SD1, GEA Niro SD4, GEA Niro SD7, Dry Powder Inhaler (DPI)
Boston or Charlotte or Chicago or Denver or New York or Salt Lake City or Colorado or Texas or Massachusetts or North Carolina or Utah or Illinois or New York or Florida or United States
$96k-$130k/yrRemoteFull Time
DEPT: Global digital agency providing integrated technology and marketing services.
5+ YOE5+ years programmatic agency experience, advanced proficiency with The Trade Desk, DV360, Amazon DSP and Google Ads/YouTube, team leadership, campaign architecture, QA, launch management, and operational/process development.
The Trade Desk, DV360, Amazon DSP, Google Ads, YouTube, Trello
Lyra Technology Group: Operates a global portfolio of managed IT service providers.
5+ YOE5+ years operations or service-delivery leadership (MSP/IT services preferred); proven experience building operational infrastructure, process documentation, change management, QA, contract lifecycle, and automation; familiarity with ConnectWise PSA and Datto RMM.
Jade BiosciencesNASDAQ: JBIO: Developing best-in-class therapies for autoimmune diseases.
10+ YOEAdvanced degree plus senior-level experience in clinical operations/QA (10+ years relevant). Strong knowledge of ICH-GCP, vendor/CRO oversight, audit/inspection support, CAPA development, and leadership skills.
Genetix Biotherapeutics: Developing and commercializing curative gene therapies for rare diseases.
10+ YOEBachelor's degree with 10+ years QA/GxP experience; strong validation and product lifecycle expertise; in-depth US/EU GMP and ICH knowledge; experience with CMOs/CTOs and inspection readiness.
Associate Director, Early Development Quality Lead, R&D QA
Cambridge or United States
$165k-$223k/yrHybridFull Time
Alnylam PharmaceuticalsNASDAQ: ALNY: Develops RNAi therapeutics to treat rare and common diseases.
8+ YOE8+ years relevant experience in bioanalytical/toxicology quality (GLP/GCP/GCLP); experience with assay development, risk-based QA, auditing, vendor oversight, and regulatory guidance across FDA/PMDA/EU/MHRA. Master's preferred.
Bridgewell: Provides social and human services for individuals with disabilities.
5+ YOE3+ MgmtMaster's degree plus 5+ years in human services, experience with data analytics, QA/QI systems, regulatory compliance (CARF, DDS, DMH, DPH), 3+ years supervisory experience, valid US driver's license.