36 qa director jobs at 28 companies in Barrington, RI
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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.
AbbVieNYSE: ABBV: Global biopharmaceutical discovering and delivering innovative medicines.
15+ YOE5+ MgmtBachelor’s degree required; 15+ years in GMP pharmaceutical, biologics, or medical device manufacturing; 5+ years leading people; advanced cGMP/GXP knowledge and project leadership skills.
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.
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.
Little People's College: Family-owned Massachusetts early education and childcare provider serving infants through school-age 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: 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.
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)
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.
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
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
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%.
5+ YOERegistered Nurse with Bachelor's (or Master/Doctorate) in inpatient care field, 5 years QA/PI experience, current state license to practice, CPHQ or eligibility within two years, leadership and data/reporting experience.
Seaport TherapeuticsNasdaq: SPTX: Public clinical-stage biopharmaceutical developing oral medicines for patients with depression, anxiety, and other neuropsychiatric disorders.
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.
Jade BiosciencesNasdaq: JBIO: Clinical-stage biotechnology developing biologic therapies for patients with autoimmune diseases.
10+ YOEBachelor's or Master's in a scientific discipline plus 12–15 years relevant experience; 10+ years operational GMP QA, CDMO management, regulatory inspection and submission experience, strong cGMP/ICH knowledge, and MS Office/SharePoint proficiency.
Microsoft Word, Microsoft Excel, Microsoft Visio, Adobe Acrobat Professional, Microsoft SharePoint