17 qa director jobs at 13 companies in Sturbridge, 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.
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.
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.
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.
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.
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
Sarepta TherapeuticsNASDAQ: SRPT: Develops precision genetic medicines for rare diseases.
15+ YOEBachelor's in life sciences with ~15 years in pharma/biotech drug development; minimum 10 years GCP/GVP QA (≥5 years focused GVP QA); clinical trial and inspection experience; QMS, SOPs, audit design, root-cause investigations, and strong technical writing skills.
Crescent BiopharmaNASDAQ: CBIO: Develops novel oncology therapies and antibody-drug conjugates for cancer.
8+ YOEPhD, MS, or BS in a relevant life science or engineering field; 8+ years in ADC bioconjugation process development and external CDMO manufacturing oversight; expertise in GMP, ICH, purification, and regulatory requirements.
Tenet HealthcareNYSE: THC: Operates a network of hospitals and ambulatory care centers.
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.
Lead Director - Commercial (ACAS) Quality Assurance
Hartford, Connecticut, United States
$100k-$232k/yrHybridFull Time
CVS HealthNYSE: CVS: Provides retail pharmacy, health insurance, and pharmacy benefit management services.
10+ YOE5+ MgmtRequires a bachelor's degree or equivalent, 10+ years in QA, quality engineering, or testing, 7+ years developing enterprise testing strategies in healthcare, and 5+ years leading transformation and large-scale testing programs.
12+ YOEBachelor's in Engineering/IT/CS, minimum 12 years in pharmaceutical quality/QA/CSV/IT compliance, leadership experience, expertise in 21 CFR and GAMP standards, GMP IT oversight, documentation and regulatory interaction skills.
Veranova: A global developer and manufacturer of complex active pharmaceutical ingredients focused on quality, compliance, and innovation.
15+ YOE10+ MgmtBS in Chemistry or related science; 15+ years QA/QC in FDA/EMA regulated industry, 10+ years managing staff, expertise in RCA/CAPA, batch production and QC labs, familiarity with Veeva, MasterControl, LIMS, TrackWise, ERP, and US/EU GMP/ICH Q7/Part 11.
Veeva, MasterControl, LIMS, TrackWise, ERP, Microsoft Word, Microsoft Excel, Microsoft PowerPoint
Crescent BiopharmaNASDAQ: CBIO: Develops novel oncology therapies and antibody-drug conjugates for cancer.
8+ YOEBachelor's in life sciences,8+ years GMP QA experience for biologics,experience with CDMOs,tech transfer,PPQ,BLA support,knowledge of global GMP and regulatory submissions.
Cogent BiosciencesNASDAQ: COGT: Develops precision therapies for genetically defined diseases
8+ YOEProvide GCP QA leadership, lead audits and inspection readiness, manage CAPAs and vendor oversight; requires 8+ years GCP QA experience and a scientific bachelor's degree.
RTXNYSE: RTX: RTX provides advanced aerospace and defense systems and services.
5+ YOE5+ MgmtRequires extensive quality/engineering/operations experience in aerospace or regulated industries (multiple degree/experience combinations accepted). Minimum 5+ years QA and 5+ years leadership; knowledge of QMS (ISO/AS9100/AS9110), audit processes, and regulatory frameworks; US citizenship required.