ImmunityBioNASDAQ: IBRX: Develops next-generation immunotherapies for cancer and infectious diseases.
4+ YOE4+ years in IT systems administration; 1+ year in a GxP environment; bachelor's in IT/CS/engineering or 8+ years with HS.; knowledge of 21 CFR Part 11 and CSV.
Windows, TCP/IP, DNS, DHCP, VLANs, Active Directory, 21 CFR Part 11, GxP, CSV
AmgenNASDAQ: AMGN: Develops and manufactures biotechnology medicines for serious diseases.
6+ YOE6+ MgmtDoctorate+6yrs OR Master’s+10yrs OR Bachelor’s+12yrs in quality/operations/digital with demonstrated digital quality and AI-enabled experience; 6yrs managerial experience; GxP/QMS platform expertise.
Manager II, Enterprise Applications (R&D & GxP Systems)
Irvine, California, United States
$134k-$188k/yrHybridFull Time
Tarsus PharmaceuticalsNASDAQ: TARS: Develops and commercializes therapeutic treatments for prevalent ophthalmic diseases.
8+ YOEBachelor’s degree and 8+ years in life sciences IT; 6+ years with GxP systems; knowledge of 21 CFR Part 11, EU Annex 11; Veeva Vault experience a plus.
Veeva Vault, QMS, GxP systems, SDLC, Validation, ERP/IT systems
Manager II, Enterprise Applications (R&D & GxP Systems)
Irvine, California, United States
$134k-$188k/yrHybridFull Time
Tarsus PharmaceuticalsNASDAQ: TARS: Developing therapeutics for eye care and infectious disease prevention.
8+ YOE8+ years IT in life sciences/pharma; 6+ years GxP systems; Veeva Vault; SDLC and validation; 21 CFR Part 11; strong communication; vendor management.
AlconNYSE: ALC: Manufactures ophthalmic surgical equipment and vision care products.
5+ YOE3+ MgmtBachelor's degree or equivalent experience, 5 years relevant experience, 3 years leadership, experience with regulatory submissions, GxP/SOP compliance, medical device/pharma support, and fluent English.
AstraZenecaLondon Stock Exchange: AZN: Researches, develops, and manufactures prescription medicines for major diseases.
5+ YOEBachelor's degree or equivalent experience; 5+ years in a GxP-regulated environment; experience with quality systems, deviations, CAPAs, change controls, controlled documents, risk assessments, SOPs, and quality metrics.
Validation - Engineer III / Lead Engineer - Project Farma
South San Francisco or Pasadena or San Diego or Portland or California or Texas or Colorado
FieldFull Time
PerkinElmer: Provides analytical instruments and laboratory services for scientific industries.
2+ YOEBachelor's in life science/engineering or equivalent, 2+ years consulting/engineering experience, CQV/GxP and validation expertise, protocol and SOP authoring, project controls familiarity, and willingness to travel extensively for client assignments.
Earned Value Analysis (EVA), GxP, CQV, Computer System Validation
Nihon KohdenTokyo Stock Exchange: 6849: Manufactures medical electronic equipment and patient monitoring systems.
6+ YOE2+ MgmtBachelor's degree in a STEM or related field, 6+ years in medical device or pharmaceutical industry, and 2+ years managing people. Requires knowledge of GxP, ISO 13485, ISO 14971, FDA 21 CFR 820, and Canadian regulations.
Quality Management System (QMS), Corrective and Preventive Action (CAPA), Configuration Management, Learning Management Systems, ISO 13485, ISO 14971, FDA 21 CFR 820, GxP, Canadian Medical Devices Regulations SOR/98-282
Manufacturing Application Engineer – Digital Manufacturing & Automation, Cell Therapy
Tarzana, California, United States
$127k-$191k/yrHybridFull Time
AstraZenecaLondon Stock Exchange: AZN: Global biopharmaceutical developing and manufacturing prescription medicines.
8+ YOE8+ years in manufacturing systems or automation with MES/LIMS experience, technical product ownership, vendor governance, API/middleware knowledge, GxP compliance, and Agile delivery.
Sr. Manager, Business Process- Cell Therapy Cost Accounting
Santa Monica, California, United States
$143k-$185k/yrOnsiteFull Time
Kite PharmaNASDAQ: GILD: Developing engineered cell therapies to treat and cure cancer.
6+ YOEAdvanced experience in ERP/business process management with SAP S/4HANA, strong understanding of cost/project accounting in manufacturing, regulatory compliance (SoX/GxP), and leadership experience.
Arrowhead PharmaceuticalsNASDAQ: ARWR: Develops RNAi medicines to treat genetic and intractable diseases.
8+ YOEBachelor's degree with 12+ years or master's degree with 8+ years of relevant GxP bioanalytical experience; expertise in method development, validation, regulated analysis, and analytical platforms required.
LC-MS/MS, LC-FL, hybrid assays, immunoassays, Good Documentation Practices (GDP)
STAAR SurgicalNASDAQ: STAA: Develops and sells implantable lenses for vision correction.
8+ YOE8+ years implementing and supporting enterprise QMS, 5+ years ComplianceQuest experience, Bachelor's in related field, ComplianceQuest/Salesforce expertise, knowledge of FDA/ISO/GxP compliance.
ComplianceQuest, Salesforce, Oracle Fusion, Oracle Integration Cloud (OIC), PLM, MES
New Brunswick or Jacksonville or Guaynabo or Irvine
$94k-$152k/yrHybridFull Time
Johnson & JohnsonNYSE: JNJ: Develops and manufactures pharmaceutical drugs and medical devices.
4+ YOERequires 4–6 years in facilities or compliance, quality systems, investigations, CAPA, nonconformances, and GxP manufacturing; high school diploma required, English proficiency, and MS Office literacy.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Quality Management System (QMS), Document Management System (DMS), Standard Operating Procedure (SOP)
FortiveNYSE: FTV: Manufactures professional instrumentation, industrial tools, and specialized software.
0+ YOEBachelor's in a scientific discipline, 0–2 years laboratory experience, strong compliance and safety knowledge, critical thinking, and effective communication; GxP/QSR/FDA/ISO experience preferred.
Altasciences: Provides clinical research and manufacturing services for drug development.
1+ YOEAdminister Master Control to support GxP compliance, provide user and IT support, manage issues, document/version control, and participate in audits; 1-4 years quality/pharma experience preferred.
RoviSys: Provides independent industrial automation and information systems integration solutions.
7+ YOE7+ years automation experience in Life Sciences, proficiency with Rockwell/Siemens/Schneider/AVEVA/PI, GxP control system design and validation, BS in engineering, strong communication and project skills.
Associate Director (Multiple Positions) | ZR_880_JOB
Westlake Village or United States
$160k/yrFieldFull Time
Agilisium: Data and AI technology consulting for life sciences companies.
5+ YOEBachelor's degree in IT, computer science, or related field plus 5 years' experience in validation engineering, with expertise in regulated data, GxP compliance, governance, clinical systems, BI, and quality systems.
RoviSys: Provides industrial automation, process control, and system integration services.
7+ YOE7+ years automation experience in Life Sciences; proficient with Rockwell/Schneider/AVEVA/PI/Siemens; GxP control system design, coding, validation; BS in engineering; strong communication and self-motivated.
Best Formulations: Contract manufacturer of nutritional supplements and personal care products.
3+ YOERequires 3–5 years supporting SAP Business One, 2+ years in batch manufacturing, and knowledge of BOMs, routings, MRP, warehouse hardware, GxP compliance, costing, and cross-functional collaboration.
SAP Business One, SAP B1, HANA, WMS, Honeywell, UROVO, Zebra, SATO, Microsoft Dynamics, CRM, OA, SRM, MRP, BOM, Computer System Validation (CSV), 21 CFR Part 11 ERES