Global GCP QA Director — Compliance & Inspections
Structure Therapeutics, Inc.
Structure Therapeutics Inc. seeks a Director, Global GCP QA to govern clinical study quality, drive continuous improvement, and ensure compliance with ICH GCP and global regulations. You will lead audits, oversee CROs, mentor QA staff, and partner with clinical functions to safeguard patient safety and data integrity. Role supports FDA/EMA inspections, performs risk-based audits, and reports to the Executive Director. Travel up to 50%; remote or onsite work possible in a hybrid model. #J-18808-Ljbffr Structure Therapeutics, Inc.
- Structure Therapeutics is seeking an Associate Director, Global GCP QA to oversee regulatory compliance for global clinical programs, including IND/NDA reviews and vendor oversight. The role reports to the Executive Director, Global GCP, QA, and supports continuous improvement...Suggested
$283k - $325k
...innovators and financed by top-tier global life sciences investors.... ...highly motivated Executive Director, Clinical Compliance to lead clinical compliance... ...on Phase 3 readiness, inspection planning, and regulatory... ...sponsor oversight documentation, GCP procedures, clinical trial...SuggestedContract work- ...day decisions align with global regulatory expectations... ...data integrity and compliance. Review and approve... ...managementtools. Serve as inspection host and primary point... ..., mentor, and develop QA team members while... ...and deliver GMP / GDP / GCP training and contamination...Suggested
- ...750,000 patients worldwide. The Director, Clinical Quality & Compliance is responsible for the strategic... ...requirements and Good Clinical Practice (GCP), and maintain inspection readiness across all studies,... ...requirements for multi-site global trials.Participates in and leads...SuggestedWork experience placementWork at officeLocal areaWorldwideRelocationShift work
- ...milestones, we are seeking a Senior Director of Quality Systems and Compliance to shape and lead our quality and... ..., you will define and execute the global compliance strategy for clinical... ...provide strategic oversight over inspection readiness across the network, quality...SuggestedWork at officeLocal areaRemote work2 days per week
$160k - $210k
...deployed across 170+ countries. About the RoleWe are seeking a Global Ops Trade and Compliance Manager to lead Verkada's international logistics,... ...primarily for vendor visits, broker meetings, and site inspections at distribution hubs.Employee BenefitsVerkada is committed...Full timeWork visaFlexible hoursShift work$210.38k - $272.25k
...together.Job DescriptionDirector, Global Supplier Quality Management ProgramPosition ImpactThe Director, Global Supplier Quality... ...working, and enhances quality, compliance, supply continuity, and... ...regulatory requirements and inspection-ready expectations.Drive risk...Full timeFor contractorsLocal area- ...Therapeutics Inc. seeks an Executive Director, Clinical Compliance to lead clinical compliance and partner with QA to ensure readiness across... ..., CRO oversight, CAPA, and inspection readiness, reporting to the... ...addressing risks across global trials in NA, Europe, and APAC...
- ...org Position Title: Director of Quality... ...Management System, QA personnel, and Quality... ...initiatives, ensuring compliance with US FDA... ...regulations, ISO 13485, and global regulatory... ...Veeva EDMS. Ensures inspection readiness and, in... ...studies to ensure GCP compliance, qualification...Full timeContract workWork at officeLocal areaWorldwide
- AbbVie in South San Francisco is seeking a Director Regulatory Affairs Global Regulatory Lead (GRL I) to develop and implement global regulatory strategies... ...products, guiding lifecycle management and ensuring compliance with worldwide regulations. The role leads the Global...Worldwide
- ...Facebook , Instagram , YouTube , LinkedIn and Tik Tok . The Director Regulatory Affairs Global Regulatory Lead (GRL I) in Global Regulatory Strategy is... ...interface with the AST and supporting teams. Ensures compliance with global regulatory requirements. Manages compounds...Worldwide
$230k - $270k
...highly motivated Senior Director CMC Regulatory Affairs in the Global Regulatory Affairs and Clinical... ...activities are in compliance with applicable... ...Sciences Manufacturing QC/QA Global Supply Chain and... ...discrepancy management and inspection management. Assess proposed...Full timeContract workInternshipLocal areaRemote work- ...possible, together.Job DescriptionThe Director, Quality Compliance and Audits (QCA) reports to the... ...leadership and governance for Gilead’s global GMP and GDP audit program. This role... ...requirements, enforcement trends, and inspection intelligence; assess potential impacts...Full timeContract workFor contractorsLocal area
- Enigma Search in the United States is seeking a Director, Regulatory CMC to lead global regulatory activities for small molecules and monoclonal antibodies, shaping strategies for accelerated development and successful product registrations. The role partners with CMC,...
- ...throughout the Bay Area. Rather than focusing solely on field inspections or traditional QA/QC documentation, this position is centered around design... ...fall below established standards Review designs for compliance with California building codes, accessibility...For contractorsFor subcontractor
$324.62k - $420.09k
...Evidence (EpiRWE), the Executive Director, Regulatory RWE Strategy and... ...Heads and their teams, Global Regulatory Affairs, Biostatistics... ...rigor, quality and compliance expected by global health authorities... ..., documentation, quality and inspection considerations relevant to observational...Full timeFor contractorsLocal areaImmediate startShift work$185k - $205k
...provide access to a $15 billion global market opportunity. Our follow-on... ...beyond. About the Role >>> Associate Director, Global Regulatory Affairs, Compliance and Project Management As the... ...support during regulatory and quality inspections. Maintain current knowledge of...Work at officeFlexible hours$200k - $247k
...We are seeking a Director of Good Manufacturing... ...will lead GMP QA oversight for drug... ...phase-appropriate GMP compliance across CMC,... ...ensuring alignment with global Quality strategy.... ...support regulatory inspections, ensuring... ...experience (GMP, GCP, GPV, and/or GLP)...Contract workTemporary workWork at officeLocal areaWork from home$222.48k - $259.56k
...Cytokinetics seeks a Director of Clinical Quality Assurance to lead global quality strategy and oversight... ...team, ensuring GCP compliance across international regulatory... ...directing audit and inspection readiness activities.... ...strategy and manage clinical QA staff development...- ...applicants for employment. Position:Director/Senior Director of Quality... ...join our Quality Assurance (QA) team. Our ideal candidate is... ..., and systems to ensure compliance with 21 CFR 4 and the relevant... ...during audits and regulatory inspections. Perform other duties as requested...Worldwide
- ...ensuring the quality and compliance of materials products... ...throughout the global supply chain. This position... ...with applicable GMP GDP GCP (where applicable) and... ...to the Senior Director Quality Assurance the... ...supporting regulatory agency inspections (FDA EMA or equivalent...Full timeContract work
$143.23k - $185.35k
...ResponsibilitiesRegulatory Strategy and Program LeadershipLead or support integrated global CMC regulatory strategies for both T-cell drug product and LVV,... ...robustness, facility controls, contamination control, and inspection-readiness narratives relevant to individualized patient...Full timeFor contractorsWork at officeLocal areaRemote workRelocationFlexible hours$153k - $178k
...on and detail-oriented Lab Compliance Manager to join our Global Analytical organization in... ...with Quality Assurance (QA), to operationalize established... ...and will report to the Director of Infrastructure and... ...records are complete and inspection-ready.Ensure equipment qualification...Work experience placement3 days per week- ...executing regulatory strategies to ensure compliance and successful product approvals. You... ...agencies such as the FDA, EMA, and other global health authorities. Ensure regulatory... ...Support internal and external audits and inspections to ensure ongoing compliance with...Contract workWork at office
- Cytokinetics, Inc. in South San Francisco, CA, is seeking a QA Specialist for Drug Substance to perform review... ..., change controls, and participate in audits, inspections, and QA metrics reporting while helping ensure compliance with cGMP and regulatory expectations. #J-18808-...
$100k - $136k
...stakeholders. ~ Strong knowledge of GCP, ICH guidelines, and regulatory... ...quality system improvement. A QA Manager in a CRO ensures compliance with Good Clinical Practice (GCP), regulatory... ...metric trend reports. Audit & Inspection Leadership: Perform audits and...Full timeContract workRemote workWorldwide$125k - $175k
...across incoming raw materials, external manufacturing, in-process inspection, finished-product qualification, traceability, and lot release... ...less direct oversight. You will report directly to our Senior Director, Manufacturing & Operations. What You'll Own Build and...Contract work- ...products. Our customers include the world’s largest and most prominent healthcare systems, governments, retailers, restaurants and global businesses who rely on us to save lives, reduce emissions, increase economic opportunity, and provide delivery from point A to point...Long term contractContract workLocal areaWorldwide
$273k - $290k
...point.We are looking for a Senior Director of Quality Assurance to build a pragmatic, inspection-ready quality function for... ...own insitro's approach to GMP and GCP quality, clinical data quality oversight... ..., with progression into senior QA leadership.Small-Company Track Record...Home officeFlexible hours3 days per week- ...Melbourne in 2015 to build the infrastructure global commerce runs on. We're the regulated... ...About the team The Legal, Risk & Compliance ( LRC ) team at Airwallex is a... ...Support and/or manage on-site exams and inspections (in collaboration with our LRC colleagues...Work at office
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