Monster Jobs lê cada vaga aberta e diz, de 0 a 100, o match dela com o seu currículo — de graça. Você está vendo esta página sem a parte mais importante dela: a sua.
Pode ser 94. Pode ser 31.
O ponteiro só crava quando lemos o seu currículo. Leva 1 minuto, de graça.
DOSSIÊ MJ-8639 · ACESSO PARCIAL
Director, Clinical Quality Lead
Kardigan · South San Francisco, California, United States, Princeton, New Jersey, United States
PresencialNão informadoDiretor
Esta é 1 de 73.985 vagas encontradas nos últimos 30 dias. Nós comparamos todas com o seu currículo — hoje, esta página nem sabe quem você é.
Grátis, sem cartão. Só o seu currículo.
Encontrada ontem
Se candidatar no escuro custa uma noite.
Saber custa um minuto.
A conta que ninguém faz
Você, sozinho, numa noite
~20
vagas abertas e lidas uma a uma — a maioria descartada no terceiro parágrafo, quando o requisito que você não tem finalmente aparece. Dias assim, toda semana.
O Monster Jobs, enquanto isso
73.985
vagas já lidas e entendidas, prontas para ganhar nota contra o seu currículo no momento em que ele chegar. Você não procura mais vaga — recebe as que merecem a sua atenção.
Recrutador faz triagem de candidato.
Aqui, o recrutador é você — de vagas.
Cada uma chega com nota e motivo. Seu único trabalho é dizer sim ou não.
RELATÓRIO DE COMPATIBILIDADE · GERADO POR VAGA, POR PESSOA
Por que essa nota
Para quem tem conta, este bloco explica a nota em português — escrito sobre o seu histórico, não um texto genérico:
O raciocínio da nota é gerado para cada currículo depois do cadastro gratuito.
Aderência técnicapeso 0.45
Senioridadepeso 0.25
Localização e modelo de trabalhopeso 0.2
Setor e contextopeso 0.1
A seu favor
O que do seu histórico pesa a favor aqui.
O que falta
O que a vaga pede e seu currículo ainda não mostra.
Liberar meu relatório grátis
1 minuto: você envia o currículo, nós escrevemos o resto.
Ninguém caça sozinho. Esta vaga foi encontrada por outra pessoa e entrou no acervo de todo mundo. A caça continua enquanto você lê isto — e a sua parte do acervo (73.985 vagas, comparadas com o seu currículo) só passa a existir quando você entra.
O que você decide sobre cada vaga
Cada vaga vira um caso com histórico: candidatei, entrevista, proposta. Estes botões são os reais — só falta a conta.
Descrição da vaga
<div class="content-intro"><p><strong><span data-contrast="auto">About Us</span></strong><span data-ccp-props="{}"> </span></p>
<div data-olk-copy-source="MessageBody">Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world.<br><br></div>
<div>It is Kardigan’s mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve.</div>
<div> </div>
<div>Led by Tassos Gianakakos, Jay Edelberg, <span data-olk-copy-source="MessageBody">M.D., Ph.D.,</span> and Bob McDowell, Ph.D., Kardigan’s co-founders have reunited after leading MyoKardia to discover and develop mavacamten, the first cardiac myosin inhibitor, resulting in an acquisition by Bristol Myers Squibb in 2020.</div>
<div> </div>
<div>We have a cutting-edge discovery and translational research platform, a pipeline of late-stage candidates, and an industry-leading team that is driven to improve the lives of patients.</div>
<div> </div>
<div>At Kardigan, we are motivated by our values which guide how we work, interact, and achieve our goals. <strong>Driven by patients and their families</strong>, we are deeply committed to improving the lives of patients and prioritizing their needs above all else. We believe in <strong>being authentic</strong>—leading with truth to bring out the best in others by creating an environment where every person knows they will be fully accepted. With an <strong>eagerness to learn</strong>, we encourage the highest levels of curiosity and are open to changing our minds. We are committed to <strong>winning as a team</strong> with urgency, excellence, and intention, and support each other no matter what role we play or where we sit. Lastly, we strive to <strong>enable the impossible</strong> because patients are counting on us. We are not afraid to take risks to unlock innovation and advance scientific discoveries.</div>
<div> </div>
<div>These values are the foundation of our work, empowering us to make a real difference, every day.</div>
<div> </div>
<div> </div></div><p><strong><span data-contrast="auto">Job Overview</span></strong><span data-ccp-props="{"134233117":false,"134233118":false,"335559738":240,"335559739":240}"> </span></p>
<p><span data-contrast="auto">The Clinical Quality Lead will play a crucial role in driving a culture of quality and ensuring that compliance is embedded throughout the R&D process. This role will be responsible for managing GxP Quality Assurance (QA) functions and providing consultation in the interpretation of GxP regulations (GCP, GLP, GVP), guidelines, policies, and procedures. This involves engaging and collaborating with cross-functional internal and external teams to evaluate processes, procedures, and activities for adherence to relevant industry standards, regulatory guidelines, and company Standard Operating Procedures (SOPs) as appropriate. </span><span data-ccp-props="{"134233117":false,"134233118":false,"335559738":240,"335559739":240}"> </span></p>
<p><strong><span data-contrast="auto">Essential Duties and Responsibilities</span></strong><span data-ccp-props="{"134233117":false,"134233118":false,"335559738":240,"335559739":240}"> </span></p>
<p><span data-contrast="auto">Essential duties may include the following tasks depending on level of experience</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559738":240,"335559739":240}"> </span></p>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto">Partners with Clinical Development/Operations and actively participates in clinical study teams to ensure GCP compliance. Reviews study-related documents and plans.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="auto">Support and maintain the internal audit program, audit schedule, and approved vendor list.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="auto">Performs internal and external audits as assigned to ensure compliance with GXP regulations and guidelines.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="4" data-aria-level="1"><span data-contrast="auto">Communicates audit results to internal stakeholders and writes audit report.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="5" data-aria-level="1"><span data-contrast="auto">Supports Quality Management System (QMS) including quality oversight and operational support for processes as e.g. CAPAs, audits, inspections, deviation management, risk management, change control and quality complaint handling.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="6" data-aria-level="1"><span data-contrast="auto">Monitor, track, and trend GxP non-conformances, deviations, CAPAs</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="7" data-aria-level="1"><span data-contrast="auto">Leads or supports audit and inspection activities, including CAPA formulation, vendor assessments, and regulatory inspections.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="8" data-aria-level="1"><span data-contrast="auto">Responsible for maintaining current regulatory inspection knowledge as it relates inspections by regulatory agencies worldwide</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="9" data-aria-level="1"><span data-contrast="auto">Interprets global legislation, regulations and guidance for development or updates to policies and standards, identify gaps and redundancies</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="10" data-aria-level="1"><span data-contrast="auto">Leads or supports backroom activities during regulatory authority inspections and assists with GxP inspection readiness activities.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="11" data-aria-level="1"><span data-contrast="auto">Build and maintain cross-functional relationships to promote GxP compliance awareness throughout the R&D organization (GCP, GVP, GLP).</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="12" data-aria-level="1"><span data-contrast="auto">Support in training initiatives on processes, new regulations and systems to enable quality compliance.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="13" data-aria-level="1"><span data-contrast="auto">Contribute to defining and monitoring compliance and quality metrics to ensure oversight of processes and projects and management review.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"> </span></li>
</ul>
<p><strong><span data-contrast="auto">Basic Qualifications </span></strong><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":1,"335551620":1,"335559685":0,"335559737":0,"335559738":240,"335559739":240,"335559740":279}"> </span></p>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto">Bachelor’s degree in a scientific discipline</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="auto">7+ years in a QMS environment with proven experience in discovery, as well as non-clinical and clinical development</span></li>
</ul>
<ul>
<li data-leveltext="o" data-font="Courier New" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":1440,"335559991":360,"469769226":"Courier New","469769242":[9675],"469777803":"left","469777804":"o","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="2"><span data-contrast="auto">Direct experience with internal/external clinical systems and process audits</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"> </span></li>
</ul>
<ul>
<li data-leveltext="o" data-font="Courier New" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":1440,"335559991":360,"469769226":"Courier New","469769242":[9675],"469777803":"left","469777804":"o","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="2"><span data-contrast="auto">Experience in QA audits of Clinical Investigator sites and clinical vendors</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"> </span></li>
</ul>
<ul>
<li data-leveltext="o" data-font="Courier New" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":1440,"335559991":360,"469769226":"Courier New","469769242":[9675],"469777803":"left","469777804":"o","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="2"><span data-contrast="auto">Experience in the development of SOPs</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"> </span></li>
</ul>
<ul>
<li data-leveltext="o" data-font="Courier New" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":1440,"335559991":360,"469769226":"Courier New","469769242":[9675],"469777803":"left","469777804":"o","469777815":"hybridMultilevel"}" data-aria-posinset="4" data-aria-level="2"><span data-contrast="auto">Knowledge and experience in Good Clinical Practices (GCP)</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="auto">Strong interpersonal, negotiation, and leadership skills.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="4" data-aria-level="1"><span data-contrast="auto">Excellent written and verbal communication skills, with experience working in a culturally diverse, global team</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="5" data-aria-level="1"><span data-contrast="auto">Ability to work independently and effectively prioritize tasks</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="6" data-aria-level="1"><span data-contrast="auto">Expertise in Root Cause Analysis, CAPA development, and Risk Management methodology</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="7" data-aria-level="1"><span data-contrast="auto">Insightful, decisive, proactive, and solutions-oriented</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="8" data-aria-level="1"><span data-contrast="auto">Proven excellence in professional skills including communication, organization, prioritization, discretion, and accuracy</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="9" data-aria-level="1"><span data-contrast="auto">Exceptional customer service skills, including cultivating and maintaining close working relationships with both internal and external stakeholders</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="10" data-aria-level="1"><span data-contrast="auto">Proficiency in MS Office including Word, Excel, PowerPoint, Outlook, SharePoint, OneNote, and virtual meeting</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="11" data-aria-level="1"><span data-contrast="auto">Available to travel as needed</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="12" data-aria-level="1"><span data-contrast="auto">Available to be on site 4 days/week</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"> </span></li>
</ul>
<p><span data-ccp-props="{"134233117":false,"134233118":false,"335559685":720,"335559738":0,"335559739":0}"> </span><strong><span data-contrast="auto">Preferred Qualifications</span></strong><span data-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"> </span></p>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="13" data-aria-level="1"><span data-contrast="auto">15+ years’ experience in the pharmaceutical or biotechnology industry with in-depth pharmaceutical QMS knowledge</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="14" data-aria-level="1"><span data-contrast="auto">Knowledge and experience in Good Laboratory Practice (GLP, and/or Good Pharmacovigilance Practice (GVP) regulations</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"> </span></li>
</ul>
<p> </p><div class="content-pay-transparency"><div class="pay-input"><div class="description"><p>Exact Compensation may vary based on skills, experience and location.</p></div><div class="title">Pay range</div><div class="pay-range"><span>$194,000</span><span class="divider">—</span><span>$253,000 USD</span></div></div></div>
Vale a pena me candidatar? Ver minha nota
Leu tudo e ficou na dúvida? É exatamente isso que a nota resolve.
Por que criar conta agora
Leva 1 minuto
Envie o currículo e pronto. Sem formulário longo, sem questionário, sem teste.
Grátis de verdade
Sem cartão, sem período de teste que expira. Seu currículo só gera as suas notas.
Já tem vaga esperando
73.985 vagas encontradas nos últimos 30 dias — a sua nota nesta e em todas as outras sai assim que o currículo chega.