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.
North Chicago or Cambridge or Worcester or Florham Park or Irvine or San Francisco or United States
$142k-$269k/yrHybridFull Time
AbbVieNYSE: ABBV: Develops and sells innovative pharmaceutical and biopharmaceutical medicines.
7+ YOEBachelor’s degree in science or healthcare, 7+ years in pharmaceutical clinical development, regulatory affairs, or quality assurance, with extensive clinical regulations, auditing, leadership, and risk management expertise.
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)
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.
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.
Innoviva Specialty TherapeuticsNASDAQ: INVA: Develops therapies for critical care and infectious diseases.
10+ YOEB.S. in a scientific/technical field, 10+ years pharma experience (7+ in QA/GMP), expertise with small-molecule product quality, inspection readiness, regulatory submissions, and proficiency with document management systems and Microsoft Office.
document management systems, Microsoft Excel, Microsoft Word, Microsoft PowerPoint