SME Lead, Regulatory, Clinical R&D, Quality
3 weeks ago
SME Lead, Regulatory, Clinical R&D, Quality & Manufacturing
Protocol Link, Inc.
10/17/2023
Job Description
Must have 10+ Years ofrelevant experience
Leadthe R&D Quality and Manufacturing team to manage GCP (good clinicalpractice) and GPV (good pharmacovigilance practices) inspections by globalregulatory health authorities.
Providestrategies and oversight for global planning-preparations and clinicalinvestigations.
Buildsystems and tools to support and oversee end-to-end inspection readinessand inspection management training.
Developstaff competencies and capabilities in inspection readiness, inspectionconduct, and CAPAs. Collaboratewith teams and SMEs to investigate and resolve inspection readiness gapsprior, during and post inspection. SupportCAPA development and perform CAPA effectiveness checks for inspectionfindings.
Contributeregulatory and quality strategies for the preparation of inspection riskassessments for senior management and key stakeholders.
ReviewQMS (Quality Management System) policies and processes for inspection readiness
Provideas-needed liaison to client’s partner and vendor inspections.
Headquartered in Chicago metropolitan area, Protocol Link is a leading project management and strategy consulting firm providing comprehensive regulatory affairs, cGMP compliance, quality assurance, and validation services to the FDA-regulated companies worldwide. Protocol Link’s mission is to provide customer-focused services with ethical conduct, mutual trust, and personnel empowerment while striving to offer the best of both quality and efficiency. It's how we've been doing business since 1996. The right way.
#J-18808-Ljbffr
-
San Francisco, United States Protocol Link, Inc. Full timeMust have 10+ Years of relevant experience Lead the R&D Quality and Manufacturing team to manage GCP (good clinical practice) and GPV (good pharmacovigilance practices) inspections by global regulatory health authorities. Provide strategies and oversight for global planning-preparations and clinical investigations. Build systems and tools to support and...
-
Accounting Manager, R&D San Francisco, CA/Hybrid
3 weeks ago
San Francisco, United States BridgeBio Full timeBridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients. Founded...
-
Senior/Principal Scientist
2 weeks ago
San Francisco, United States R&D Partners Full timeR&D Partners is seeking to hire a Senior/ Principal Scientist in Translational Medicine Mass Spectrometry (Contractor) in San Franciscon, CA. Your main responsibilities as a Senior/ Principal Scientist in Translational Medicine Mass Spectrometry (Con Scientist, Principal, Clinical Research, Spectrometry, Chemistry, Staffing
-
San Francisco, United States R&D Partners Full timeR&D Partners is seeking to hire a Necropsy Scientific Researcher/ Senior Scientific Researcher in South San Francisco, CA. Your main responsibilities as a Necropsy Scientific Researcher/ Senior Scientific Researcher: This position is embedded within Research, Senior, Research Scientist, Clinical Research, Technology, Staffing
-
Research Associate
2 weeks ago
San Francisco, United States R&D Partners Full timeR&D Partners is seeking to hire a Research Associate III in South San Francisco, CA. Your main responsibilities as a Research Associate III: This laboratory-based role involves performing, qualifying and implementing biological assays and technologie Research Associate, Associate, Research, Clinical Research, Technology, Staffing
-
Research Associate I
3 weeks ago
San Francisco, United States R&D Partners Full timeR&D Partners is seeking to hire a Research Associate I in South San Francisco, CA. Your main responsibilities as a Research Associate I:A successful candidate will participate in the identification of novel components in innate immune responses and c Research Associate, Associate, Research, Clinical Research, Microbiology, Technology, Staffing
-
Senior Supply Chain Specialist
5 days ago
San Francisco, United States R&D Partners Full timeR&D Partners is seeking to hire a, Senior Supply Chain Analyst in San Carlos, CA. The primary function of this position is to oversee material inventory and storage and manage global material shipments through service provider and partner ecosystem ( Supply Chain, Specialist, Senior, Supply, Shipping, Clinical Research, Transportation, Staffing
-
Research Associate
3 days ago
San Francisco, United States R&D Partners Full timeR&D Partners is seeking to hire a Research Associate I in South San Francisco, CA. Your main responsibilities as a Research Associate I: Recording scientific observations during gross examinations Excising, weighing, and fixating tissues during necro Research Associate, Associate, Research, Clinical Research, Technology, Staffing
-
Research Associate II/III
3 weeks ago
South San Francisco, United States R&D Partners Full timeJob DescriptionJob DescriptionBiotechnology company is seeking a highly motivated candidate who wants to gain knowledge and develop lab skills in Next Generation Sequencing (NGS) technology and genomics research. The candidate will work in the high-throughput NGS lab, which provides support for sequencing technology and develops genomics applications in...
-
Director, R&D Finance
3 weeks ago
San Francisco, United States Abnormal Security Full timeJob Description Job Description About the Role As a leading AI Cybersecurity firm on the cutting edge of technology and innovation, our company safeguards digital integrity with unparalleled AI-driven solutions. Amidst our rapid growth trajectory, we seek a strategic and visionary Director of R&D Finance to oversee financial strategies that underpin our...
-
Manager, R&D and Clinical Accounting
2 weeks ago
South San Francisco, United States Allogene Therapeutics Full timeAbout Allogene: Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of...
-
San Diego, California, United States Surf Search Full timeWe are searching for a Senior R&D Engineer with experience developing electrophysiology products including catheters for diagnostic, imaging or ablation treatments. As a Senior R&D Engineer in Electrophysiology, you'll spearhead efforts on the R&D team focusing on next-generation catheters for diagnostic, imaging, and ablation treatments. This hands-on role...
-
Senior Accountant
2 weeks ago
San Rafael, United States R&D Partners Full timeJob DescriptionJob DescriptionBiotechnology company is hiring a 9-month contract Senior Accountant to join the US Controllership team. You will be part of a great team who values flexibility, excellence, integrity, and work-life balance. This role is highly visible to communicate and collaborate across different teams and functions of our business. A strong...
-
Senior Accountant
3 weeks ago
San Rafael, United States R&D Partners Full timeJob DescriptionJob DescriptionBiotechnology company is hiring a 9-month contract Senior Accountant to join the US Controllership team. You will be part of a great team who values flexibility, excellence, integrity, and work-life balance. This role is highly visible to communicate and collaborate across different teams and functions of our business. A strong...
-
Sr. R&D Engineer
2 weeks ago
San Diego, United States cesna Full timeJob DescriptionJob Description[Position]Sr. R&D Engineer (R&D)[About Our Client]The company, founded in 2002 in Seoul, South Korea, is the world leader in 3D measurement and inspection technology used in the production of micro-electronics assemblies. Using patented 3D technology, the company provides best-in-class products in Solder Paste Inspection(SPI)...
-
Sr. R&D Engineer
3 days ago
San Diego, United States Cesna - Recruitment experts worldwide Full time[Position] Sr. R&D Engineer (R&D) [About Our Client] The company, founded in 2002 in Seoul, South Korea, is the world leader in 3D measurement and inspection technology used in the production of micro-electronics assemblies. Using patented 3D technology, the company provides best-in-class products in Solder Paste Inspection(SPI) and Automated Optical...
-
Financial Analyst
5 days ago
San Mateo, United States GoPro Full timePartner with the R&D leadership team to drive results and meet business targets Lead FP&A activities for the R&D team, including monthly close, annual budget, quarterly forecasts, and resource tracking by working with the operational teams Analyze bu Financial Analyst, Financial, Analyst, Business Partner, Banking, Support
-
Regulatory Strategy Consultant
7 days ago
San Rafael, United States Katalyst Healthcares and Life Sciences Full timeResponsibilities: Provide strategic insight to the GRT regarding product development, and serve as Regulatory contributor to partner teams (eg, study execution teams, clinical development team etc.) as appropriate In collaboration with regional regulatory representatives, ensure that feedback from global Health Authorities is incorporated into the...
-
Packaging Technician
2 weeks ago
San Diego, United States R&D Partners Full timeJob DescriptionJob DescriptionSummary:Responsible for the manual assembly of blood screening kits according to manufacturing instructions. Primary responsibilities for role:● Typically includes competencies of Packaging Technician I position plus:● Direct interaction with internal customers● Investigate inventory discrepancies● Maintain...
-
Quality Consultant SME Pharma Medical Devices
2 weeks ago
San Francisco, United States Excellis Health Full timeJob DescriptionJob DescriptionSalary: Excellis Health Solutions, LLC, an NNIT Group Company, is a global strategic management consulting services firm, based in New Hope, PA, England, Belgium and Denmark. An industry leader in supply chain, with a focus in Pharmaceuticals and Life Sciences and a specific niche in serialization, we offer a multitude of...