- Insmed Incorporated (San Diego, CA)
- …strategic direction with cross functional working groups to identify and mitigate GCP quality and compliance issues.Supports the evaluation and acceptability of ... (Essential Role Responsibilities):Establish and maintain a risk-based and scientific-based quality system to support GCP .Oversee regulatory agency inspections… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryThe Manager Audits & Compliance, GCP /Document Audits supports end-to-end audit activities per audit program of GxP ... least 7 or more years of professional experience in Quality and clinical development in the Pharmaceutical industry, with...at least 4 or more years proficiency in ICH GCP Guidelines, US and European regulatory requirements for the… more
- Eisai, Inc (Nutley, NJ)
- …of all aspects of end-to-end clinical trials with the utmost compliance and quality consistent with Good Clinical Practice ( GCP ). This individual must ... expedite clinical operations activities. These activities directly impact the timeliness, quality , and successful execution of clinical studies in accordance with… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is responsible for ... design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the … more
- Merck & Co. (North Wales, PA)
- …cross-functionally to monitor clinical data to ensure quality , completeness, and integrity of trial conduct.Providing tactical/scientific ... the ability to:Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing priorities with good planning,… more
- Merck & Co. (Rahway, NJ)
- …Management/Programming. Collaborating cross-functionally to monitor clinical data -to ensure quality , completeness , and integrity of trial conduct. Providing ... Core Skills Solid knowledge of clinical research regulatory requirements (e . g . , GCP and ICH) Ability to manage multi e competing priorities with good -planning ,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with License Partners, Patient Support Programs, Market Research vendors, Global Quality Supply Chain, Medical Information Social Media and other suppliers.Ensure ... adequate training of resources to enable quality of deliverables. Manage quality , efficiency, and...required4 or More Years Knowledge of Good Clinical Procedures ( GCP ) and Good Pharmacovigilance Procedures (GVP) required4 or More… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for risk mitigation.Support the stakeholders in identifying and defining quality improvement initiatives for development activities / programs post internal ... system audit.Support reporting of quality metrics for audits and inspections and execute against...trials, clinical safety, pharmacovigilance Must have proficiency in ICH GCP Guidelines, US and European regulatory requirements for the… more
- Twist BioScience (South San Francisco, CA)
- …across our biomanufacturing operations. This critical role will drive efficiency, quality , and robust data integrity within a highly automated environment. The ... professionals, primarily software developers, who work in concert with Manufacturing Operations, Quality Assurance, and R&D. The Director will serve as the primary… more
- Genmab (NJ)
- …development and be part of a dynamic, collaborative team that values innovation, quality , and scientific integrity? At Genmab, we are seeking a passionate and ... our Global Medical Writing team, you will drive the development of high- quality clinical documents to support operational, medical, and regulatory activities across… more
- Twist BioScience (South San Francisco, CA)
- …and storage solutions.Background in assay development, genomics-based diagnostics, or quality control for high-throughput NGS data.Software Development & DevOps ... familiarity with containerization (Docker, Kubernetes), CI/CD, and cloud platforms (AWS, GCP , or Azure).Experience with monitoring, logging, and alerting tools for… more
- Taiho Oncology (FL)
- …product(s) and compounds to ensure awareness and understanding. Provides high quality scientific information to healthcare professionals (HCPs) Serve as a conduit ... disease states which are of interest to Taiho Oncology, study methodology, GCP , clinical information, and product data Demonstrate full knowledge of and ability… more
- Eisai, Inc (Nutley, NJ)
- …and in accordance with standard operating procedures (SOP), good clinical practice ( GCP ) and specific country regulations such as site and vendor selection, ... internal reviews, reconciliation and study file archivalPerforms detailed eTMF CRO quality check reviews with follow-up for missing documentation under the… more
- BeOne Medicines (Emeryville, CA)
- …and Experience: + BA/BS degree required; advanced degree preferred. + GCP Quality Assurance auditor's registration/certification preferred. + Minimum of ... Perform on-site or remote audits (routine, for-cause/directed); Evaluate compliance with GCP regulations, internal quality standards, and relevant guidelines;… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …evolving global clinical regulations and guidance. + Support the development of GCP Audit material/insights for quality forums and management reviews. _Training ... aspirations. Join Gilead and help create possible, together. **Job Description** Gilead R&D Quality is a phenomenal place to develop your skills and expertise. Our… more
- TEKsystems (Trafford, PA)
- …communication and change control standards. * Maintain client satisfaction while ensuring quality and governance of GCP solutions. Practice & Product Line ... experience you've been searching for? We're looking for a GCP Practice Architect 2 to join our team. A...is a leadership-level role focused on Google Cloud Platform ( GCP ) delivery and practice development. The role oversees consulting… more
- Regeneron Pharmaceuticals (Armonk, NY)
- The Head, Global Development Quality Standards & Continuous Improvement (GDQSCI) will lead and support the GDQSCI sub-function, ensuring effective oversight of ... responsibilities and team management. As a member of the Global Development Quality Governance & Oversight (GDQGO) Leadership Team, this role involves overseeing the… more
- Danaher Corporation (Austin, TX)
- …of the job include: + Bachelor's degree in science with 14+ years of clinical quality / GCP experience within the device industry OR + Master's degree in science ... with 12+ years of clinical quality / GCP experience within the device industry + Knowledge of US requirements and regulations related to Good Clinical Practice… more
- Takeda Pharmaceuticals (Boston, MA)
- …Management and Statistics, with at least 3 years of experience in GCP Quality /Compliance. + Advanced knowledge of pharmaceutical development, medical affairs ... **About the role:** The Associate Director, Clinical and Safety Quality Compliance is responsible for ensuring the quality...and GCP /GVP regulations including FDA, EU, MHRA, PMDA and ICH.… more
- Takeda Pharmaceuticals (Boston, MA)
- …Management and Statistics, with at least 3 years of experience in GCP Quality /Compliance. + Advanced knowledge of pharmaceutical development, medical affairs ... **Job Description** **About the role:** Associate Director, Clinical Program Quality Investigations is responsible for ensuring the compliance of...and GCP /GVP regulations including FDA, EU, MHRA, PMDA and ICH.… more
