(Senior) Director, Drug Safety and Pharmacovigilance Operations
Vancouver, BCAbCellera: AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology,…
12+ ansCandidates need at least 12 years of drug safety or PV experience, ideally with monoclonal antibodies, and a healthcare degree such as RN, PharmD, PA or NP. They must have expert knowledge of global PV regulations, safety database experience (ARGUS, ARISg, Veeva Vault Safety) and a record of managing FDA, EMA and Health Canada interactions.
ARGUS, ARISg, Veeva Vault Safety
QA Specialist - Batch Record Review
Vancouver, BCAbCellera: AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology,…
5+ ansCandidates need a BSc in a relevant science with 5+ years of industry experience, or an MSc with 3+ years, in QA, QC or manufacturing in a cGMP-regulated environment. They need hands-on batch record review experience, knowledge of Health Canada, FDA, EU and ICH cGMP requirements, and strong attention to detail.
ERP system
External QA Specialist/Manager
Vancouver, BCAbCellera: AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology,…
5+ ansCandidates need a relevant science bachelor's degree and 5+ years of QA experience (Specialist) or 8+ years (Manager) in a regulated life sciences environment, including external biologics manufacturing. They need deep knowledge of global cGMPs, strong eQMS and SAP or Veeva skills, and excellent attention to detail and communication.
Veeva, SAP