experience in GLP, GCP, GVP, and Quality Systems, providing exposure throughout the drug development lifecycle Direct experience... that drive operational excellence and establish quality standards Provide oversight of GCP/GVP/GLP/RWE projects and programs...
, Data Management and Statistics, with at least 3 years of experience in GCP Quality/Compliance. Advanced knowledge... trial delivery quality systems, promoting operational and compliance excellence, quality risk management and knowledge...
development, clinical operations, or data management, with expertise in GCP compliance. Advanced knowledge of global GCP/GVP.... Act as a Subject Matter Expert (SME) on Clinical Quality Compliance activities, including deviation management, quality...
in enterprise data governance and quality management Experience managing large-scale data initiatives in $1B+ software... development. Inclusive Workplace: Collaborate with a diverse team in an inclusive, global workplace that fosters innovation...
for GxP domains (GMP, GLP, GCP, GDP, etc.) that aligns with corporate quality goals. Periodically adjust the plan based.... Metrics Development & Data-Driven Reporting Evaluate audit results and quality data to establish and sustain metrics...
, or governmental regulations Experience with risk-based Supplier Quality Management process. Management of Global Inspection... the thought of building an entirely new digital quality management system, excite you. Do you love to design...
Quality/Compliance. Advanced knowledge of pharmaceutical development, medical affairs and GCP/GVP regulations including FDA..., Enterprise Audit, etc.) to Global Quality and R&D Quality. Present to CPMQ at periodic intervals the status, insights and impact...
), Pharma affiliates and global regulated processes (GVP, GCP and Medical Device). The Opportunity The Quality Assurance... we love. That’s what makes us Roche! In Pharma Development Quality (PDQ) we strive to demonstrate confidence in the...
or relevant experience in quality management, Drug Development, GCP, GVP, GLP and regulatory compliance. Required Competencies... to Global Quality Councils, Enterprise Risk Committees, and relevant Drug Development Governance forums and assure alignment...
and a desire to make a tangible impact? We have a thrilling opportunity for a Quality Excellence Lead to join our Global Quality... that drive a thriving future for our Quality and Product Development organization. The Opportunity A healthier future. It...
including ICH guidelines. Experience with quality metrics, management of quality events (i.e. serious breach), assessment of GCP... establishment of site Key Quality Indicators (KQIs), to enable global, high-quality clinical trial execution. Monitor risk signal...
, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Clinical Data Quality Associate... development and implementation of data quality processes and procedures to maintain high standards throughout the data lifecycle...
to our Engineering and Operations teams, embedding a culture of quality and performance from the earliest stages of development.... ● Quality Assurance: Establishes and enforces quality standards and best practices throughout the software development lifecycle...
(R3), Computerized Systems Used in Clinical Trials, Computer System Validation, Quality Management Systems Processes Who...At Insmed, every moment and every patient counts - and so does every person who joins in. As a global biopharmaceutical...
, and Quality risk management. Direct experience with clinical manufacturing, analytical method development/validation, tech... compliance across manufacturing development, while providing strategic Quality leadership across internal teams and external...
purpose, join us as we transform and accelerate research and development. As a Quality Assurance Manager, you will oversee... and coordinate QA programs supporting customer accounts, audits, and quality systems at a regional and global level. You will lead...
Location: On-site | Employment Type: Full-time We are seeking an experienced, detail-oriented, and proactive Quality.... The ideal candidate will have extensive experience managing internal quality systems and ensuring compliance...
, delivery and execution of the global Clinical Quality Assurance (CQA) strategy including audit and inspection management, issue... management and oversight of the Quality management system. This role is responsible for Good Clinical Practice (GCP...
or more years of management experience. PREFERRED EDUCATION: Typically a Bachelor's Degree or global equivalent in related...We are seeking a results-driven Manager – Quality Engineering, Digital Technologies to lead the strategy, execution...
of global regulatory inspections (FDA, EMA, MHRA, etc.) across GMP, GCP, and GLP functions. Oversee Quality Systems, policies... development through commercialization, covering GxP operations, Quality Systems, Quality Assurance, R&D/Clinical Quality...