Executive Director, Global GCP QA

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    "description": "<p><span style=\"font-weight: bold\"><span><span>About Us</span><span>:</span></span></span><span> </span></p>\n<p><span><span>Structure<span> </span></span><span>Therapeutics develops life‐changing medicines for patients using advanced structure‐based and computational drug discovery technology. The company’s platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs. We are advancing a clinical‐stage pipeline of differentiated treatments focused on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions.</span></span><span> </span></p>\n<p><span><br></span></p>\n<p><span><span>Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors. The company completed<span> </span></span><span>an initial</span><span><span> </span>public offering (IPO) in February</span><span><span> </span></span><span>2023. With offices in California and Shanghai, Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and capitalizing on the strengths of each geographic location.</span></span><span> </span></p>\n<p><span> </span></p>\n<p><span style=\"font-weight: bold\"><span><span>Position Summary:</span></span></span><span> </span></p>\n<p><span><span>Reporting to the Vice President, Quality</span><span> this position will </span><span>be responsible for</span><span> ensuring all clinical </span><span>studies</span><span> conducted by Structure </span><span>comply with</span><span> all relevant global regulations and guidelines, e.g. (FDA, EMA, NMPA, ICH)</span><span>.  </span><span>The scope of this strategic role covers both sponsor and outs</span><span>ourced activities of clinical </span><span>trials</span><span>, developing a high performing team of GCP experts and fostering an understanding and importance of GCP’s across the company, ensuring patient safety and data integrity</span><span>.  </span></span><span> </span></p>\n<p><span style=\"font-weight: bold\"><span><br></span></span></p>\n<p><span style=\"font-weight: bold\"><span><span>Job </span><span>Responsibilities</span><span>:</span><span> </span></span></span><span> </span></p>\n<ul>\n<li><span><span>Act as the primary GCP QA subject matter expert and point of contact for all GCP/PV</span><span><span> </span></span><span>-</span><span> </span><span>  related matters and issues.</span><br></span><span> </span></li>\n</ul>\n<ul>\n<li><span><span>Ensure ongoing clinical trials are compliant with relevant global regulations and guidelines.</span><br></span><br><span>Develop and support quality audit strategy for all clinical trials, including investigator site audits, </span><span>V</span><span>endor</span><span>/CRO audits.</span><br><span style=\"font-size: 12pt\"> </span></li>\n</ul>\n<ul>\n<li><span><span>Provide quality oversight and GCP guidance to clinical study teams and CROs/vendors to ensure compliance with ICH GCP, applicable regulatory requirements.</span><br></span><span> </span></li>\n</ul>\n<ul>\n<li><span><span>Evaluate clinical trial </span></span><span><span>IND/IMPD/NDA enabling</span></span><span><span> documentation, study processes, and operational </span></span><span>pla</span><span>n</span><span>s</span><span> to confirm alignment with </span><span style=\"font-size: 12pt\"><span>relevant global regulations and guidelines.</span><br></span><span style=\"font-size: 12pt\"> </span></li>\n</ul>\n<ul>\n<li><span><span>Final quality decision authority on critical deviations, investigations, and quality risk management in </span><span>GCP</span><span> domain with a focus on risk-based thinking and operational efficiency.</span><br></span><span> </span></li>\n</ul>\n<ul>\n<li><span><span>Establish </span><span>appropriate meeting</span><span> cadence with Clinical Development Operations to </span><span>leverage</span><span> cross-department information, </span><span>identify</span><span> and correct issues early, and </span><span>eliminate</span><span> potential redundancies in </span></span><span>activities.</span><br><span style=\"font-size: 12pt\"> </span></li>\n</ul>\n<ul>\n<li><span><span>Partner with clinical functions to </span><span>provide</span><span> quality guidance and drive the implementation of fit-for-purpose procedures that ensure data and documentation are generated and managed in </span></span><span>compliance</span><span> with GCP.</span><br><span style=\"font-size: 12pt\"> </span></li>\n</ul>\n<ul>\n<li><span><span>Work with cross </span><span>f</span><span>unctional teams to assess and manage risks associated with vendors, supporting study compliance, data integrity, and participant safety.</span><br></span><span> </span></li>\n</ul>\n<ul>\n<li><span><span>Support the creation, maintenance, and improvement of quality SOPs, manuals, templates, process maps, and approval flows to </span><span>establish</span><span> a robust GCP QMS.</span><br></span><span> </span></li>\n</ul>\n<ul>\n<li><span><span>Ensure the periodic reporting of key quality metrics to leadership to support continuous improvement in GCP compliance across Structure.</span><br></span><span> </span></li>\n</ul>\n<ul>\n<li><span><span>Lead GCP inspection readiness, regulatory authority inspections, and partner audits.</span><br></span><span> </span></li>\n</ul>\n<ul>\n<li><span><span>Promote a culture of quality through effective communication, training, and proactive engagement with internal and external stakeholders.</span><br></span><span> </span></li>\n</ul>\n<p><span> </span></p>\n<p><span style=\"font-weight: bold\"><span><span>Key Competencies</span><span>:</span></span></span><span><br></span><span> </span></p>\n<ul>\n<li><span><span>Ability to </span><span>identify</span><span> and hire excellent candidates </span><span>possessing</span><span> the correct skills at the right time and organizational level. </span></span><span> </span></li>\n</ul>\n<ul>\n<li><span><span>Highly organized and detail-oriented, with the ability to manage multiple priorities in a fast-paced, evolving environment. </span></span><span> </span></li>\n</ul>\n<ul>\n<li><span><span>Exceptional leadership, project management, and communication skills. </span></span><span> </span></li>\n</ul>\n<ul>\n<li><span><span>Demonstrated examples of strategic planning with successful outcomes. </span></span><span> </span></li>\n</ul>\n<ul>\n<li><span><span>Contemporary GCP knowledge of current agency and industry trends, standards, and methodologies</span></span><span> </span></li>\n</ul>\n<p><span style=\"font-weight: bold\"><span><br></span></span></p>\n<p><span style=\"font-weight: bold\"><span><span>Education/</span><span>Qualifications</span><span>:</span><span> </span></span></span><span> </span></p>\n<ul>\n<li><span><span>BS, or equivalent, in a scientific discipline </span><span>required</span><span>; MS or PhD degree is preferred.</span><br></span><span> </span></li>\n</ul>\n<ul>\n<li><span><span>Auditor certifications </span><span>required</span><span>; SQA RQAP GCP credentials are preferred.</span><br></span><span> </span></li>\n</ul>\n<ul>\n<li><span><span>15+ years of progressive experience in Clinical Quality Assurance within global pharmaceutical, biotechnology organizations, or CRO.</span><br></span><span> </span></li>\n</ul>\n<ul>\n<li><span><span>Minimum 5 years overseeing outsourced clinical trial </span><span>model</span><span> and direct GCP auditing experience.</span><br></span><span> </span></li>\n</ul>\n<ul>\n<li><span><span>Proven leadership leading GCP regulatory inspections.</span><br></span><span> </span></li>\n</ul>\n<ul>\n<li><span><span>Expertise</span><span> in GCP and ICH E6(R3); knowledge of 21 CFR Part 11/EU Annex 11, and pharmacovigilance a plus.</span><br></span><span> </span></li>\n</ul>\n<ul>\n<li><span><span>Prior</span><span> success in designing and implementing electronic quality management system (</span><span>eQMS</span><span>) and electronic document management system (</span><span>eDMS</span><span>).</span><br></span><span> </span></li>\n</ul>\n<p><span> </span></p>\n<p><span> </span></p>\n<p><span> </span></p>\n<p><span style=\"font-weight: bold\"><span><span>Travel Required:</span><span> </span></span></span><span><span>Typically,</span><span> 20% based on business </span><span>needs</span><span>.  </span></span><span> </span></p>\n<p><span> </span></p>\n<p><span style=\"font-weight: bold\"><span><span>Structure Therapeutics </span><span>Inc. is an </span><span>E</span><span>qual-</span><span>O</span><span>pportunity </span><span>E</span><span>mployer.</span></span></span><span> </span></p>\n<p><span><span>Structure Therapeutics </span><span>is committed to fair and </span><span>equitable</span><span> compensation </span><span>practices,</span><span> and we strive to provide employees with total compensation packages that are market competitive. For this role, the </span><span>anticipated</span><span> base pay range is </span><span>$275,000 - $325,000</span><span>. The exact </span><span>base</span><span> pay offered for this role will depend on </span><span>various factors</span><span>, including but not limited to the candidate’s geography, qualifications, skills, and experience.</span></span><span> </span></p>\n<p><span><span>At </span><span>Structure</span><span>, base pay is only one part of your total compensation package. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. </span><span>Structure Therapeutics </span><span>also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, </span><span>unlimited PTO, </span><span>and a number of paid holidays</span><span> including winter shutdown</span><span>.</span><span> </span></span><span> </span></p>\n<p><span style=\"font-weight: bold\"><span><br></span></span></p>\n<p><span style=\"font-weight: bold\"><span><span>Notice to Recruiters/Staffing Agencies</span></span></span><span> </span></p>\n<p><span><span>Recruiters and staffing agencies should not contact </span><span>Structure Therapeutics </span><span>through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees.</span></span><span> </span></p>\n<p><span><span>We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file.</span></span><span> </span></p>\n<p><span><span>Structure Therapeutics</span><span>’ receipt or acceptance of an unsolicited resume </span><span>submitted</span><span> by a vendor organization to this website or employee does not constitute an actual or implied contract between </span><span>Structure Therapeutics </span><span>and such organization and will be considered unsolicited and </span><span>Structure Therapeutics </span><span>will not be responsible for related fees. </span></span><span> </span></p>\n<p><span style=\"font-weight: bold\"><span><br></span></span></p>\n<p><span style=\"font-weight: bold\"><span><span>Fraud Alert</span></span></span><span> </span></p>\n<p><span><span>To all candidates: your personal information and online safety are a top priority for us. At </span><span>Structure Therapeutics</span><span>, direct candidates to apply through our official career page at </span></span><a href=\"https://structuretx.bamboohr.com/careers\" target=\"_blank\" rel=\"noopener noreferrer\"><span><span>BambooHR</span></span></a><span><span>.</span></span><span> </span></p>\n<p><span><span>Recruiters will always contact you using the domain of </span><span>Structure</span><span>tx.com. We will never request payments, ask for financial account information or sensitive information like social security numbers. If you are unsure if a message is from </span><span>Structure Therapeutics</span><span>, please email human resources.</span></span><span> </span></p>\n<p><span> </span></p>",
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