26 qa director jobs at 19 companies in Acushnet, 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
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.
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.
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.
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
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.
Seaport Therapeutics: Develops oral neuropsychiatric medicines using a proprietary technology platform.
12+ YOEBachelor's degree with 12+ years related experience (8+ years in clinical QA preferred). Deep knowledge of global regulations (FDA, EMA, ICH, GxP), audit and inspection readiness, vendor oversight, and strong communication skills.
Associate Director, Early Development Quality Lead, R&D QA (Cambridge, MA, US, 02142)
Cambridge, Massachusetts, United States
$165k-$223k/yrHybridFull Time
AlnylamNasdaq: ALNY: Developing and commercializing RNA interference (RNAi) therapeutics for diseases.
8+ YOE8+ years relevant quality experience in bioanalytical/toxicology with GLP/GCP/GCLP knowledge; experience in vendor oversight, auditing, risk-based QMS, and biomarker assay familiarity; master's degree preferred.
Massachusetts Bay Transportation Authority: Operates public transportation services in the Greater Boston area.
5+ YOE2+ MgmtBachelor's in engineering/architecture/construction management,5+ years heavy construction experience in transit (structures/movable bridges),2 years supervisory experience,PE preferred,valid driver's license,24/7 availability,and strong project delivery and QA/QC skills.
Foundation Medicine: Molecular profiling for personalized cancer treatment and research.
5+ YOEBoard-certified molecular genetic pathologist with 5+ years post-training experience, NGS fellowship and NYS qualification for oncology-molecular markers; experience with NGS testing, SOP review, QA, and staff supervision.
Celea Therapeutics: Developing transformative therapies for serious respiratory diseases.
10+ YOEBachelor's or master's degree in a scientific discipline and 10+ years in pharmaceutical or biotechnology QA, with GMP drug product manufacturing, quality systems, audits, CAPA, validation, and regulatory inspection experience.
Formation Bio: Accelerating drug development through an AI-native pharmaceutical platform.
10+ YOEBachelor's in a scientific discipline,10+ years GMP QA experience in biologics,deep knowledge of FDA/EMA/ICH,CMC and CMO oversight,investigations and documentation skills,excellent communication and organization.
Director / Senior Director, GCP Quality Assurance Lead (US/IL/EU)
Boston or Israel or Europe or United States
RemoteFull Time
Prilenia: Develops therapeutic drugs for neurodegenerative diseases.
10+ YOE3+ MgmtBachelor’s degree in life sciences/pharmacy (advanced degree preferred), 10+ years GCP QA experience (≥3 years leadership), deep GCP/GvP/GLP expertise, inspection experience, eTMF and QMS proficiency, and strong communication skills.