Reporting to the Vice President, Quality this position will be responsible for ensuring all clinical studies conducted by Structure comply with all relevant global regulations and guidelines, e.g. (FDA, EMA, NMPA, ICH). The scope of this strategic role covers both sponsor and outsourced activities of clinical trials, 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. Job Responsibilities:
Act as the primary GCP QA subject matter expert and point of contact for all GCP/PV - related matters and issues. - Ensure ongoing clinical trials are compliant with relevant global regulations and guidelines. Develop and support quality audit strategy for all clinical trials, including investigator site audits, Vendor/CRO audits. - Provide quality oversight and GCP guidance to clinical study teams and CROs/vendors to ensure compliance with ICH GCP, applicable regulatory requirements. - Evaluate clinical trial IND/IMPD/NDA enabling documentation, study processes, and operational plans to confirm alignment with relevant global regulations and guidelines. - Final quality decision authority on critical deviations, investigations, and quality risk management in GCP domain with a focus on risk-based thinking and operational efficiency. - Establish appropriate meeting cadence with Clinical Development Operations to leverage cross-department information, identify and correct issues early, and eliminate potential redundancies in activities. - Partner with clinical functions to provide quality guidance and drive the implementation of fit-for-purpose procedures that ensure data and documentation are generated and managed in compliance with GCP. - Work with cross functional teams to assess and manage risks associated with vendors, supporting study compliance, data integrity, and participant safety. - Support the creation, maintenance, and improvement of quality SOPs, manuals, templates, process maps, and approval flows to establish a robust GCP QMS. - Ensure the periodic reporting of key quality metrics to leadership to support continuous improvement in GCP compliance across Structure. - Lead GCP inspection readiness, regulatory authority inspections, and partner audits. - Promote a culture of quality through effective communication, training, and proactive engagement with internal and external stakeholders. Key Competencies:
Ability to identify and hire excellent candidates possessing the correct skills at the right time and organizational level. - Highly organized and detail-oriented, with the ability to manage multiple priorities in a fast-paced, evolving environment. - Exceptional leadership, project management, and communication skills. - Demonstrated examples of strategic planning with successful outcomes. - Contemporary GCP knowledge of current agency and industry trends, standards, and methodologies
Education/Qualifications:
BS, or equivalent, in a scientific discipline required; MS or PhD degree is preferred. - Auditor certifications required; SQA RQAP GCP credentials are preferred. - 15+ years of progressive experience in Clinical Quality Assurance within global pharmaceutical, biotechnology organizations, or CRO. - Minimum 5 years overseeing outsourced clinical trial model and direct GCP auditing experience. - Proven leadership leading GCP regulatory inspections. - Expertise in GCP and ICH E6(R3); knowledge of 21 CFR Part 11/EU Annex 11, and pharmacovigilance a plus. - Prior success in designing and implementing electronic quality management system (eQMS) and electronic document management system (eDMS). Travel Required: Typically, 20% based on business needs. Structure Therapeutics Inc. is an Equal-Opportunity Employer. Structure Therapeutics is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $275,000 - $325,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience. At Structure, 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. Structure Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, unlimited PTO, and a number of paid holidays including winter shutdown. Notice to Recruiters/Staffing Agencies
Recruiters and staffing agencies should not contact Structure Therapeutics 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. We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file. Structure Therapeutics’ receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Structure Therapeutics and such organization and will be considered unsolicited and Structure Therapeutics will not be responsible for related fees. Fraud Alert
To all candidates: your personal information and online safety are a top priority for us. At Structure Therapeutics, direct candidates to apply through our official career page at BambooHR. Recruiters will always contact you using the domain of Structuretx.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 Structure Therapeutics, please email human resources.
