- BeiGene (San Mateo, CA)
- …for implementing and maintaining a balanced, proactive, and phase appropriate approach to GCP Quality Assurance . This position will be primarily responsible ... **_General Description:_** The Senior Manager , GCP Inspection Management is responsible...**Essential Functions of the job:** Manage and oversee the GCP Quality Assurance activities: +… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …industry experience. Experience working in either a quality /compliance role (eg, Quality Management, Quality Assurance etc..), or in a Clinical ... The Manager , Global Development Quality Standards &...you if have:** * Knowledge, understanding and application of GCP , and/or GVP guidelines including the management of fundamental… more
- CACI International (VA)
- …changes and develop post-implementation verification routines. . Ensure compliance of GCP environments by collaborating with Information Assurance (IA) teams. ... Cloud Architect GCP Job Category: Information Technology Time Type: Full...in infrastructure as code tools (eg, Terraform, Cloud Deployment Manager ). . Strong scripting skills (Python, Go, etc.). .… more
- Chiesi (Cary, NC)
- Senior GCP Auditor Date: Jan 10, 2025 Department: Corporate R&D Quality Assurance Job Type: Direct Employee Team: Quality Contract Type: Permanent ... (Chiesi Group). To achieve its mission of improving people's quality of life by acting responsibly towards society and...compliance and the correct application of Good Clinical Practice ( GCP ), inside the clinical development of the Global R&D… more
- United Therapeutics (Silver Spring, MD)
- …Qualifications + 2+ years in a clinical process or operations role + Certified Quality Manager (CQM)-ASQ RQAP- GCP and/or ASQ-CQA + Experience providing ... and 2 days/week work from home. + Develop Clinical Quality Assurance (CQA) Standard Operating Procedures and...biotech/pharmaceutical industry experience + 5+ years of experience within GCP Quality + GCP experience… more
- AbbVie (North Chicago, IL)
- …or equivalent experience required + 5+ years of pharmaceutical industry experience in GCP quality assurance or regulatory affairs or clinical development ... Facebook, Instagram, YouTube and LinkedIn. Job Description The Program Manager - Clinical Quality Assurance ... is primarily responsible for leading the management of GCP quality activities in support of studies… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and Specialty Medicine strategic priorities, by reviewing and monitoring the status of Quality Events (QEs), CAPAs and GCP compliance matters raised to the ... Quality Leads (RQLs) by reviewing and monitoring the status of Quality Events (QEs), CAPAs and GCP compliance matters raised to the GQLs and/or RQLs from the… more
- University of Pennsylvania (Philadelphia, PA)
- …and wellness programs and resources, and much more. Posted Job Title Quality Assurance Specialist (Regulatory) CVPF(Center for Cellular Immunotherapy) Job ... Profile Title Research Coordinator Senior Job Description Summary The Quality Assurance Specialist will work within the...issuance and external audits, DFPs, CAPAs review. + Assisting Manager as needed to help with raw materials release,… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …degree and MBA preferred. + Minimum of 15 to 20 years of experience in quality management or design assurance with at least 5-7 years of management experience ... the following processes in support of the Global Design Assurance team: + Oversight over the global risk management...of governance and operating mechanisms focused on driving product Quality and Compliance objectives. + Oversight of Quality… more
- IQVIA (Raleigh, NC)
- …global portfolio or a particular asset(s). These activities will be in collaboration with Quality Assurance (QA) and the Quality Lead/Specialist, as needed. ... quality deliverables + Support teams in adherence to GCP and procedural documents and processes to ensure ...GCP and procedural documents and processes to ensure quality deliverables + Work with teams to escalate … more
- Abeona (Cleveland, OH)
- JOB TITLE Sr. Manager , Clinical / Non-Clinical Quality Department Quality Assurance Reports To Associate Director of Quality Assurance or above ... Ladder Level 5 DESCRIPTION Position Overview The Sr. Manager , Clinical / Non-Clinical Quality is responsible...supporting quality programs and oversight of daily quality assurance activities supporting clinical operations and… more
- Amgen (Washington, DC)
- …end quality support for the development and implementation of a risk-based quality assurance strategy for the clinical development program. Each Senior ... for a career you can be proud of. **Senior Manager , Therapeutic Area Quality ** **LIVE** **What you...and imaging methods). + Support the development of TA-specific Quality Assurance plans that are risk based… more
- PCI Pharma Services (Philadelphia, PA)
- …Associate Quality Account Manager I **Applicant must have experience in Quality Assurance for this position to apply The Associate Quality Account ... Assist with creating and/or reviewing batch records to support the business. Primary Quality Assurance contact for assigned customer accounts. + Assist as… more
- Amgen (Washington, DC)
- …proactive end-to-end quality support for developing and implementing a risk-based quality assurance strategy for the clinical development program. The R&D ... the lives of patients while transforming your career. **Senior Manager , Quality & Compliance** **LIVE** **What you...**Preferred Qualifications:** + 7 years or more experience in ** quality management** , ** quality assurance **… more
- HistoWiz (Long Island City, NY)
- …by accelerating histopathology and enabling global collaboration. We are looking for a Quality Assurance Specialist interested in joining our mission and serving ... customers' growing histology needs. Who are you? The Senior Manager /Director of Quality is responsible for overseeing...field + At least 5 years of experience in Quality Assurance working at a CRO, pharma,… more
- PCI Pharma Services (Rockford, IL)
- …remaining within cGMP guidelines and PCI procedures and policies. + Provide proactive quality assurance and risk assessment using FMEA, HCCAP, and Quality ... Coordinator(s) while partnering with the Sr. Clinical Project Manager to ensure that we deliver a quality...Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. + Attendance at work is… more
- Mount Sinai Health System (New York, NY)
- …allocate tasks to ensure timelines and objectives are met. **Regulatory Compliance and Quality Assurance :** + Ensure all trials adhere to Good Clinical Practice ... **Job Description** The **Project Manager II** will oversee the entire portfolio of...including protocols, amendments, and safety reports. + Conduct regular quality assurance checks to identify and mitigate… more
- University of Utah (Salt Lake City, UT)
- …evaluate the effectiveness of mentorship programs and make improvements as necessary. ** Quality Assurance and Compliance:** + Establish and maintain quality ... Details **Open Date** 10/29/2024 **Requisition Number** PRN40207B **Job Title** PS Manager , Clinical Research **Working Title** PS Program Manager **Job Grade**… more
- Astellas Pharma (Northbrook, IL)
- …closely with CTL to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified ... in remote work are encouraged to apply. **Purpose and Scope:** A Clinical Site Manager II (CSM II) serves as the primary contact point between the Sponsor and… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …limited to, Clinical Operations, Chemistry, Manufacturing and Controls (CMC), Product Quality Assurance (PQA),Regulatory Affairs and Sourcing departments. + ... real-world evidence, and creating hope for all facing illness. The Senior Manager , Clinical Supplies will manage the complete clinical supply chain of… more
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