Associate Director/Director, Q

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About Theseus Theseus Pharmaceuticals is passionately committed to improving the lives of cancer patients by working to outsmart cancer resistance. Led by a team of targeted oncology pioneers with a proven track record developing and commercializing cancer therapeutics, we are developing the next generation of tyrosine kinase inhibitors (TKIs): "pan-variant" targeted therapies that address all known drug resistant mutations. We believe a pan-variant approach is the only way to address cancer resistance. Our lead program, THE-630, is a pan-variant KIT inhibitor for patients with advanced gastrointestinal stromal tumors (GIST), whose cancer has developed resistance to earlier lines of kinase inhibitor therapy. We are also developing a fourth-generation, selective epidermal growth factor receptor (EGFR) inhibitor to address C797S-mediated resistance to first- or later-line osimertinib treatment in patients with non-small cell lung cancer (NSCLC). For more information, visit theseusrx.com or follow the company on LinkedIn . Role Description The Associate Director/Director, Quality Assurance is responsible for the strategic development and operational management of Theseus's quality assurance program. The individual will support Good Clinical Practices (GCP) and Pharmacovigilance (PV) as well as manage and collaborate with external consultants/contractors, as necessary, to support QA activities in Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP). In addition, this role will be accountable for the execution and administration of the Quality Management System in support of the GxP functions, and quality compliance at Theseus and its vendors in accordance with FDA, ICH, EMA regulations and guidelines and industry standards. The Associate Director/Director, Quality Assurance will build relationships with external consultants/contractors, as necessary, to support QA activities and responsibilities, and will provide guidance to the organization on global quality matters. At minimum, this position requires expertise in current GCP and PV Quality relevant regulations. This role is accountable for ensuring that sites and vendors are compliant with global regulations, prepared for potential Sponsor Audits and Regulatory Inspections, an
About Theseus Theseus Pharmaceuticals is passionately committed to improving the lives of cancer patients by working to outsmart cancer resistance. Led by a team of targeted oncology pioneers with a proven track record developing and commercializing cancer therapeutics, we are developing the next generation of tyrosine kinase inhibitors (TKIs): "pan-variant" targeted therapies that address all known drug resistant mutations. We believe a pan-variant approach is the only way to address cancer resistance. Our lead program, THE-630, is a pan-variant KIT inhibitor for patients with advanced gastrointestinal stromal tumors (GIST), whose cancer has developed resistance to earlier lines of kinase inhibitor therapy. We are also developing a fourth-generation, selective epidermal growth factor receptor (EGFR) inhibitor to address C797S-mediated resistance to first- or later-line osimertinib treatment in patients with non-small cell lung cancer (NSCLC). For more information, visit theseusrx.com or follow the company on LinkedIn . Role Description The Associate Director/Director, Quality Assurance is responsible for the strategic development and operational management of Theseus's quality assurance program. The individual will support Good Clinical Practices (GCP) and Pharmacovigilance (PV) as well as manage and collaborate with external consultants/contractors, as necessary, to support QA activities in Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP). In addition, this role will be accountable for the execution and administration of the Quality Management System in support of the GxP functions, and quality compliance at Theseus and its vendors in accordance with FDA, ICH, EMA regulations and guidelines and industry standards. The Associate Director/Director, Quality Assurance will build relationships with external consultants/contractors, as necessary, to support QA activities and responsibilities, and will provide guidance to the organization on global quality matters. At minimum, this position requires expertise in current GCP and PV Quality relevant regulations. This role is accountable for ensuring that sites and vendors are compliant with global regulations, prepared for potential Sponsor Audits and Regulatory Inspections, an
Contacte al anunciante