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.
Scholar RockNASDAQ: SRRK: Develops monoclonal antibodies for serious neuromuscular and metabolic diseases.
8+ YOEBachelor's degree or equivalent experience, 8+ years in enterprise applications, and 4+ years implementing Veeva Vault in regulated GxP environments. Requires Veeva expertise, vendor management, validation, data integrity, and stakeholder leadership.
Zifo: Provides scientific informatics services for life sciences R&D organizations.
4+ YOEBachelor's/Master's in pharma/biotech/biomedical/chemical, 4+ years relevant experience (incl. 1 year software dev/testing and 1 year business analysis), lab IT troubleshooting, validation/compliance, customer liaison, and MS Office proficiency.
Unix, Windows, MVS, Object Oriented Programming, Structured Programming, Waterfall, Agile, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Visio, Microsoft Project, Microsoft SharePoint
Ionis PharmaceuticalsNASDAQ: IONS: Discovers and develops RNA-targeted medicines for serious diseases.
3+ YOEBachelor's degree in a science-related field, 3+ years quality assurance experience in pharmaceutical/biotech, strong knowledge of GxP/GMP and quality systems, familiarity with AI in GxP desirable, strong communication and problem-solving.
5+ YOEBachelor's in a scientific discipline (or equivalent), 5+ years QA/document control experience in regulated biotech/pharma, GxP/eQMS knowledge, audit/CAPA/training support, Smartsheet and Microsoft Excel proficiency.
electronic Quality Management Systems (eQMS), Smartsheet, Microsoft Excel
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.
Verista: Provides compliance, automation, and validation services to life sciences.
3+ YOEMaster's with 3–5 years quality/validation experience or Bachelor's with 8+ years; cGMP knowledge; QA oversight of GMP manufacturing; validation and aseptic experience; experience with Veeva, Nuvolo, ViewLinc.
Veeva, Nuvolo, ViewLinc, Building Management Systems (BMS), Environmental Monitoring Systems (EMS)
Veeva Vault RIM Test & Validation Lead (CSV / QEA)
Boston, Massachusetts, United States
$71k-$113k/yrHybridFull Time
CognizantNASDAQ: CTSH: Provides IT consulting and technology services to global enterprises.
3+ YOE3–5 years Veeva Vault RIM configuration/support; 8+ years CSV; life sciences with GxP; regulatory affairs knowledge; experience with regulatory submissions.
Veeva Vault RIM Test & Validation Lead (CSV / QEA)
Boston, Massachusetts, United States
$71k-$113k/yrHybridFull Time
CognizantNasdaq: CTSH: Provides global information technology and business process outsourcing services.
8+ YOE3–5 years Veeva Vault RIM configuration; 8+ years CSV experience; Life Sciences with GxP; Regulatory Affairs and eCTD knowledge; regulatory submission experience.
ModernaNasdaq: MRNA: Develops and manufactures messenger RNA medicines and vaccines.
6+ YOEBachelor's in CS/Engineering, 6+ years in industrial software/automation or systems integration, experience with APIs/middleware and robotics software, GMP/GxP familiarity, support for FAT/SAT and commissioning.
Assoc. Dir , Product Manager, Disease Biology & PharmTox
West Point or Boston or Cambridge or Rahway
$142k-$224k/yrOnsiteFull Time
Merck & Co.NYSE: MRK: Develops and manufactures prescription medicines, vaccines, and animal health products.
5+ YOERequires a scientific or technical degree and 5+ years of scientific software, pharmaceutical sciences, target discovery, or scientific data management experience; expertise in product management, Agile, SDLC, GxP, and stakeholder leadership.
Terrestrial: Develops micro-array patch technology for patient-friendly drug delivery.
0+ YOEBachelor's or master's degree in a relevant science or engineering discipline; formulation process development experience; 0–2 years for Engineer I or 3+ years for Engineer II; GxP documentation, communication, and problem-solving skills.
BC Platforms: Provides secure data platforms for healthcare and life sciences.
8+ YOE8+ years in security, compliance or governance; CISSP or CISM preferred; experience with ISO 27001, GDPR, SOC 2, GxP/21 CFR Part 11; cloud security, audit readiness, stakeholder engagement and strong communication.
ISO 27001, GDPR, SOC 2, GxP, 21 CFR Part 11, EHDS, EU AI Act
Principal ProServe Cloud Architect, Healthcare and Life Sciences (HCLS) , AWSI Sales, AWSI Sales
Boston or Jersey City or Arlington or New York or Chicago or Raleigh or Dallas
$183k-$272k/yrOnsiteFull Time
AmazonNASDAQ: AMZN: Global online retail and cloud computing technology provider.
8+ YOE8+ years cloud architecture experience, bachelor's in CS/Math or related, experience with enterprise AI/ML and agentic AI, pharmaceutical/life sciences domain knowledge (CDISC, GxP, HIPAA, GDPR), and experience positioning cloud solutions to executives.
Sarepta TherapeuticsNASDAQ: SRPT: Develops precision genetic medicines for rare diseases.
Provide GxP oversight for vendor management and GPV/GLP/GCLP audits, develop audit plans/reports, evaluate vendor responses, support inspections, and maintain GxP quality documentation.
Kymera TherapeuticsNASDAQ: KYMR: Develops targeted protein degradation medicines to treat human diseases.
5+ YOEBachelor's in life sciences, 5+ years quality systems/GxP/document control experience in a sponsor organization, hands-on eQMS administration, GxP training program management, knowledge of 21 CFR Part 11 and ICH E6(R3).
Veeva Vault, Microsoft Word, Microsoft Excel, Microsoft PowerPoint