- 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 ... **Essential Functions of the job:** Manage and oversee the GCP Quality Assurance activities: +... Assurance activities: + Conduct and/or oversee the quality assurance ( QA ) inspection readiness… 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
- 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
- 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 ... the delivery and execution of non-project initiatives within R&D Quality and Global RD/PV QA by collaborating...Leads (RQLs) by reviewing and monitoring the status of Quality Events (QEs), CAPAs and GCP compliance… 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 ...or clinical operations + Prefer 1+ years of GCP QA auditing experience Other Required Skills:… 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...cross functional teams to ensure on time delivery of QA review, errors are resolved and investigations are initiated… 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
- Bristol Myers Squibb (Seattle, WA)
- …. **Position Summary** The primary responsibility of the Global QA Patients Operations Manager is to act as regional Quality Single Point of Contact. The ... Global QA Patients Operations Manager will ensure a consistent approach to the operational...in writing. + Serve on project teams by providing quality assurance guidance and input regarding … 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
- Bristol Myers Squibb (New Brunswick, NJ)
- …personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Senior Manager of Specialty Laboratory Quality will be responsible for ... GCP ) regulations. They also act as a laboratory quality and compliance subject matter expert (SME) to key...and provide advice and counsel concerning GCLP, GLP and GCP regulatory requirements. + Conduct Quality System… 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 ... :** + Is point of contact for assigned regional quality and compliance questions, working with QA ...quality deliverables + Support teams in adherence to GCP and procedural documents and processes to ensure … more
- AdventHealth (Orlando, FL)
- …(FDA) regulations and the International Conference on Harmonization/Good Clinical Practices (ICH/ GCP ) guidelines. The Ops Manager oversees the workflows, ... **Clinical Research Operations Manager - Surgery & Orthopedics Research** **- AdventHealth...Managers to ensure all research projects are of high quality , are operationally feasible and meet the needs of… 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
- 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
- University of Pennsylvania (Philadelphia, PA)
- …activities in single center and multicenter studies (including international sites), instituting quality assurance and quality control measures for analysis ... and much more. Posted Job Title Clinical Research Project Manager B (Abramson Cancer Center) Job Profile Title Clinical...and training, data and lab management, protocol compliance and QC/ QA , human subjects protection and GCP , and… more
- Astellas Pharma (Northbrook, IL)
- …Works closely with CTL to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance ( QA ) site audits and for quality issues ... 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. + ... agreements, including Confidential Disclosure Agreements (CDA), Master Services Agreements (MSA), and Quality Agreements ( QA ) are current for all approved CPOs.… more
- J&J Family of Companies (Raritan, NJ)
- …Works closely with LTM to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance ( QA ) site audits and for quality issues ... Johnson & Johnson is currently seeking an Associate Site Manager to cover the southeast region (Washington, DC to Florida). This position can be located remotely in… 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
- 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