Associate Director, Clinical Quality Assurance

<div class="content-intro"><p><em>Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, </em><em>is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders. Centessa’s lead investigational candidate – cleminorexton (formerly ORX750) – is being developed for narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. Centessa's OX2R agonist portfolio includes additional clinical and preclinical-stage assets with potential utility across a broader range of neurological, neurodegenerative, and neuropsychiatric conditions.</em></p> <p><em> </em><em>Headquartered in Boston, Massachusetts, Centessa was recognized as a <strong>Great Place to Work</strong>® in 2026.</em></p></div><p><strong>Description of Role</strong></p> <p><span class="TextRun SCXW55759648 BCX0" lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW55759648 BCX0">The Associate Director, Clinical Quality Assurance (CQA) will oversee GCP-focused quality assurance for Centessa-sponsored clinical trials (Early to Late Phase), ensuring compliance with global regulations, ICH guidelines, Centessa SOPs, and industry standards. This role leads daily clinical quality operations, </span><span class="NormalTextRun SCXW55759648 BCX0">maintains</span><span class="NormalTextRun SCXW55759648 BCX0"> effective quality programs and documentation, and ensures GCP compliance and </span><span class="NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW55759648 BCX0">inspection</span><span class="NormalTextRun SCXW55759648 BCX0"> readiness across all regulatory requirements.</span></span><span class="EOP Selected SCXW55759648 BCX0" data-ccp-props="{}"> </span></p> <p><strong>Key Responsibilities</strong></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="10" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto">Lead and maintain GCP QA programs, policies, and procedures.</span></li> <li data-leveltext="" data-font="Symbol" data-listid="10" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">Serve as primary GCP QA expert and point of contact.</li> <li data-leveltext="" data-font="Symbol" data-listid="10" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">Ensure clinical programs comply with global health authority regulations and ICH guidelines.</li> <li data-leveltext="" data-font="Symbol" data-listid="10" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">Provide QA oversight for protocols, ICFs, CSRs, and other trial documents.</li> <li data-leveltext="" data-font="Symbol" data-listid="10" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">Monitor evolving GCP regulations and communicate impact to stakeholders.</li> <li data-leveltext="" data-font="Symbol" d