37 qa director jobs at 30 companies in Haverhill, MA
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Sr Director, QA- GxP Systems
Needham, Massachusetts, United States
$258k-$280k/yrHybridFull Time
Candel TherapeuticsNasdaq Global Market: CADL: Public clinical-stage biopharmaceutical developing off-the-shelf viral immunotherapies for patients with 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 Global Market: NTLA: Clinical-stage biopharmaceutical developing CRISPR-based gene-editing treatments for people with severe diseases.
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 Global Select Market: DYN: Clinical-stage biotechnology developing targeted therapies for people with 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: A global partner to the pharmaceutical and biotech industries.
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 Pharmaceuticals, Inc.NASDAQ: RYTM: Commercial-stage biopharmaceutical developing precision medicines for patients with rare neuroendocrine 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.
Climb BioNASDAQ: CLYM: Public clinical-stage biotechnology developing immune-mediated disease treatments for patients.
8+ YOEBachelor's degree in a scientific or engineering field and 8–14+ years of progressive GMP quality assurance experience in biotech or pharma, including clinical-stage manufacturing and investigational product management.
North Chicago or Cambridge or Worcester or Florham Park or Irvine or San Francisco or United States
$142k-$269k/yrHybridFull Time
AbbVieNYSE: ABBV: Global biopharmaceutical discovering and delivering innovative 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 Capital Market: CBIO: Clinical-stage oncology biotechnology developing bispecific antibodies and antibody-drug conjugates for people with solid tumors.
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.
Nova Biomedical: A private US manufacturer of analytical instruments and consumables serving biopharmaceutical, clinical, veterinary, and food-and-beverage customers.
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: U.S. manufacturer of advanced electrolyzer plants serving heavy industry and clean-hydrogen developers.
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: Public biotechnology developing precision genetic medicines for patients with rare 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 Capital Market: AGEN: Clinical-stage biotechnology developing immunotherapies for patients with cancer and infectious diseases.
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.
Catalent: Global contract development and manufacturing organization for pharmaceutical and biotechnology industries.
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: Private holding operating independently managed managed-IT service businesses for small and midsize organizations worldwide.
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.
Genetix Biotherapeutics: Privately held commercial-stage biotechnology delivering FDA-approved genetic therapies for patients with severe 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.
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: Empowering individuals with disabilities and life challenges.
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 Therapeutics: Private biopharmaceutical subsidiary developing and delivering therapies for patients in critical care and infectious disease.
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
Olema OncologyNasdaq: OLMA: Clinical-stage biopharmaceutical developing targeted therapies for patients with metastatic breast cancer and other solid tumors.
8+ YOEBachelor's required (advanced degree preferred),8+ years in pharmaceutical GMP/GMP QA, knowledge of cGMP, small-molecule experience, NDA/BLA submission experience, quality systems familiarity, strong leadership and communication.
Veeva, TrackWise, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft SharePoint
Ionis PharmaceuticalsNasdaq: IONS: Public biotechnology developing and commercializing RNA- and DNA-targeted medicines for people with serious diseases.
5+ YOEAdvanced degree and extensive GCP QA experience (varies by degree: BSc+12 yrs, MSc+8 yrs, PhD+5 yrs or equivalent). Strong knowledge of ICH/GCP, inspection readiness, audit conduct, CAPA management, risk-based QA, and ability to travel 30–40%.