Associate Director, Early Development Quality Lead, R&D QA
Cambridge or United States
$165k-$223k/yrHybridFull Time
Alnylam PharmaceuticalsNASDAQ: ALNY: Develops RNAi therapeutics to treat rare and common diseases.
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.
Ascensus Specialties: Manufacturer of high-purity specialty chemicals and reagents.
7+ YOE5+ MgmtBachelor's in a technical discipline, 7+ years QA/QMS experience in regulated manufacturing, 5+ years leading quality personnel, audit and CAPA expertise, strong leadership and project management skills.
AlkermesNASDAQ: ALKS: Develops medicines for psychiatric and neurological disorders.
10+ YOEBSc in a scientific discipline, 10+ years pharmaceutical experience (preferably oral solid dose) with strong analytical, cleaning validation, manufacturing QA, cGMP and data integrity expertise; up to 15% travel.
Arizona or North Carolina or Virginia or United States or Georgia or Texas or Florida or Boston or Colorado
$80k-$100k/yrRemoteFull Time
Apryse: Provides software development kits for digital document processing.
4+ YOE2+ Mgmt4+ years in sales ops/lead generation/QA, 2+ years people management, experience with pipeline/SDR functions, strong analytical and process orientation, experience using data to drive decisions; Salesforce familiarity a plus.
Los Angeles or Orange or El Segundo or Denver or Sacramento or Addison or Boston or Chicago or Royal Oak or San Francisco or San Diego or United States
$190k-$220k/yrHybridFull Time
HED: Integrated architecture and engineering firm providing design services.
15+ YOEBachelor’s degree in electrical engineering; PE licensure; 15+ years in AEC; experience leading offshore/distributed teams; EOR for large data-center projects; strong leadership and QA/QC skills.
Waltham or United States or Puerto Rico or North America
$78k-$113k/yrHybridFull Time
SanofiEuronext Paris: SAN: Researches, develops, and manufactures medicines and vaccines globally.
5+ YOEBachelor's degree or equivalent; minimum 5 years experience in training, learning management, quality, compliance, documentation, or QA; LMS and iLearn experience preferred; familiarity with GxP training requirements.
Tata Consultancy ServicesNational Stock Exchange of India: TCS: Global provider of IT services, consulting, and business solutions.
8+ YOE8+ years IT and QA experience, 5+ years supporting pharma/life sciences, experience leading global testing delivery, knowledge of GxP/CSV/CSA and 21 CFR Part 11, stakeholder management, test strategy and data validation.
Tango TherapeuticsNasdaq Capital Market: TNGX: Develops precision cancer medicines using synthetic lethality principles.
8+ YOEManage and continuously improve QMS for GxP compliance, document control, training, records, CAPA, metrics, and audit readiness; 8+ years QA/Compliance and bachelor\u0002s in life sciences/quality required.
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
Tampa or Jersey City or Dallas or Boston or Coppell
$75k-$150k/yrHybridFull Time
DTCC: Provides post-trade infrastructure for the global financial services industry
5+ YOE5+ years in QA/quality engineering for enterprise software, experience testing blockchain and distributed-ledger platforms, strong manual and automated testing skills, test framework development, API and web app testing, CI/CD experience.
Gentex: Produces advanced personal protection systems for defense and emergency responders
5+ YOE2+ MgmtBachelor's degree in a relevant computing or engineering field and 5+ years of software QA/testing experience, including embedded systems; leadership, automated testing, CI/CD, and regulated-program experience preferred.
Associate Director, Early Development Quality Lead, R&D QA (Cambridge, MA, US, 02142)
Cambridge, Massachusetts, United States
$165k-$223k/yrHybridFull Time
AlnylamNasdaq: ALNY: Developing and commercializing RNA interference (RNAi) therapeutics for diseases.
8+ YOE8+ years relevant quality experience in bioanalytical/toxicology with GLP/GCP/GCLP knowledge; experience in vendor oversight, auditing, risk-based QMS, and biomarker assay familiarity; master's degree preferred.
Research Development Quality Inspection Management Lead (GCP/GVP) (Billerica, Massachusetts, US, 01821)
Billerica or Boston
$139k-$209k/yrHybridFull Time
MerckXETRA: MRK: A science and technology providing healthcare, life science, and electronics solutions.
8+ YOE8+ years QA experience (≥5 years in Clinical QA), Bachelor’s in a scientific field, experience with MHRA/FDA/EMA/PMDA inspections, knowledge of drug development and GCP/GLP/GVP, willingness to travel globally up to 20%.
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.
Director / Senior Director, GCP Quality Assurance Lead (US/IL/EU)
Boston or Israel or Europe or United States
RemoteFull Time
Prilenia: Develops therapeutic drugs for neurodegenerative diseases.
10+ YOE3+ MgmtBachelor’s degree in life sciences/pharmacy (advanced degree preferred), 10+ years GCP QA experience (≥3 years leadership), deep GCP/GvP/GLP expertise, inspection experience, eTMF and QMS proficiency, and strong communication skills.
Lead Compliance Analyst / Safety Auditor - 90205030 - WIL / PHL / CHI / DC / BOS / NY
Wilmington or Philadelphia or Chicago or Washington or Boston or New York City
$94k-$122k/yrHybridFull Time
Amtrak: Operates America's national intercity passenger railroad system.
6+ YOEBachelor's degree or equivalent education and 6 years of relevant experience; driver's license required. Requires compliance, safety assurance, QA/QC, data analysis, regulatory knowledge, and Microsoft Office proficiency.
Microsoft Power BI, Enablon, Microsoft Word, Microsoft Excel, Microsoft SharePoint, Microsoft PowerPoint
Mariana OncologyNYSE: NVS: Developing precision radioligand therapies for solid tumors.
10+ YOEBachelor’s degree in a scientific or engineering discipline,10+ years QA experience in pharma/biotech, knowledge of global GMP/21CFR/ICH, experience with aseptic/radiopharmaceutical operations, and ability to lead QA teams.
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)