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
Revolution MedicinesNASDAQ: RVMD: Developing precision oncology therapies for RAS-addicted cancers
15+ YOE8+ MgmtAdvanced scientific degree preferred, 15+ years of GxP quality and compliance experience, 8+ years leading global quality organizations, and experience with FDA and international regulatory inspections.
Quality Management System (QMS), Key Performance Indicators (KPIs), computerized system validation (CSV), electronic Quality Management Systems (eQMS)
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
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.
Associate Director Clinical Quality Assurance and GxP Compliance
Novato or South San Francisco
$199k-$246k/yrHybridFull Time
UltragenyxNASDAQ: RARE: Developing and commercializing therapies for rare genetic diseases.
7+ YOEBachelor's degree in a scientific or technical discipline, 7+ years in healthcare or biopharmaceuticals, regulatory inspection leadership, and quality assurance or compliance experience preferred.
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.
NovartisSIX Swiss Exchange, NYSE: NOVN, NVS: A global pharmaceutical developing and manufacturing medicines.
3+ YOEBachelor's degree in life sciences, chemistry, or related field; 3+ years in GxP biopharmaceutical or API manufacturing; 2+ years in regulated-environment quality assurance.
Johnson & JohnsonNYSE: JNJ: Provides pharmaceutical products and medical technology healthcare solutions.
5+ YOEBachelor’s degree or equivalent experience; 5+ years as a Product Analyst, 7+ years in PLM, 2+ years in medical devices, GxP and validation experience, Agile and stakeholder leadership skills.
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.
Quality Control Scientist II (Fully Onsite Position)
South San Francisco, California, United States
$79k-$141k/yrOnsiteFull Time
AbbVieNYSE: ABBV: Develops and sells innovative pharmaceutical and biopharmaceutical medicines.
7+ YOEBS with 7+ years or MS with 5+ years, including 2+ years in antibody release and stability testing, GMP stability analysis, JMP or statistical tools, LIMS, document management, and GxP environments.
Sagimet BiosciencesNasdaq: SGMT: Develops oral FASN inhibitor drugs for metabolic and inflammatory diseases.
12+ YOE5+ MgmtBachelor's degree in a scientific discipline, 12–15 years of pharmaceutical or biotech quality experience, 5+ years of senior leadership, GxP, CMC, GMP, regulatory inspection, and CMO/CDMO oversight expertise.
Quality Management System (QMS), SOPs, GxP, GCP, GMP, GLP, CAPA, 21 CFR, FDA, EMA, IND, NDA, BLA, CMC, APR, PQR, DS, DP, CTM, CMO, CDMO, ICH, CTA, MAA
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
RocheSIX Swiss Exchange: ROG: Develops and manufactures innovative medicines and diagnostic tests.
4+ YOEBachelor's in L&D or life sciences and 4 years in learning/training roles; experience with Cornerstone and CIDM, agile methodologies (Scrum, Product Ownership, SAM), instructional design, GxP regulations, and pharma drug development lifecycle.
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
SalesforceNYSE: CRM: Sells cloud-based customer relationship management and business software solutions.
2+ YOE2–4 years GRC/compliance/audit or information security experience; working knowledge of at least two of SOC 2, HIPAA, ISO 27001, or GxP; proficiency with GRC/audit tools and Microsoft Office or Google Workspace; strong communication skills.
SOC 2, HIPAA, ISO 27001, GxP, Microsoft Office Suite, Google Workspace, Drata, Vanta, OneTrust, ServiceNow GRC
RezoluteNASDAQ: RZLT: Clinical-stage biopharmaceutical developing therapies for rare metabolic diseases.
15+ YOE15+ Mgmt15+ years supply chain leadership in pharma/biotech; experience with commercial launch, global biologics/small molecule supply chains, GxP cold-chain logistics, S&OP, ERP, trade compliance, and team building; bachelor’s required, MBA preferred.
ERP, S&OP, Harmonized Tariff Schedule (HTS), Shipping System Qualification (SSQ), GCP, GMP, GDP
NovartisNew York Stock Exchange: NVS: Develops and manufactures innovative prescription medicines for patients.
8+ YOEBachelor's in a related field, 8+ years in clinical/GMP labs, 3+ years supporting IVD development, regulatory knowledge (GxP, Part 11, ICH, ISO, CLIA/CAP, IVDR, QSR), molecular biology familiarity, statistical understanding, strong communication.