- Contract Pharmacal Corp (Hauppauge, NY)
- Senior Manager ; QA Compliance (Audits) Hauppauge, NY (http://maps.google.com/maps?q=135+Adams+Avenue+Hauppauge+NY+11788) * Quality Assurance Apply Description ... Position Summary: The Sr. Manager of Quality Assurance Compliance - Audits has primary...the Document Control team and facility compliance to support audit functions. Responsibilities:Responsibilities include, but are not limited to:… more
- HistoWiz (Long Island City, NY)
- …into GLP to support our customers' growing histology needs. Who are you? The Senior Manager /Director of Quality is responsible for overseeing the quality and ... accountable for the execution of assigned company GLP QA audit activities ensuring that the current regulations, policies, and...aims to build from the ground up, not just audit . GENERAL RESPONSIBILITIES AND SPECIFIC DUTIES + Develop, review… more
- Catalent Pharma Solutions (San Diego, CA)
- ** Senior Manager , Quality Assurance** **Position Summary:** **Catalent Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at ... regulatory compliance, and sound fiscal responsibility. The primary responsibilities of the Senior QA Manager include activities related to GMP (Good… more
- Catalyst Clinical Research LLC (Bolton, NC)
- As a Senior Project Manager - Oncology, you will be responsible for the routine cross-functional operations of assigned studies for one or more clients or ... + Coordinate, plan and execute Investigator Meetings as needed. May need support from a Senior Project Manager . + Lead internal project team meetings. + May lead… more
- Novo Nordisk (Lexington, MA)
- …to develop new medicines for patients. The Position We are looking to hire a Senior Clinical Project Manager (CPM). This is a unique opportunity to work in ... programs based on an innovative RNAi technology platform. The Senior CPM will be responsible for all aspects of...the Trial Master File (TMF) and assist with periodic audit of the TMF + Drive critical clinical trial… more
- BeiGene (Emeryville, CA)
- …in the region and provides regular updates on study progress in the region to senior management and Global Clinical Study Manager as required + Represents the ... of the Clinical Study Report in collaboration with Global Clinical Study Manager and Medical Writing **Quality:** + Handles escalated issues or problems with… more
- Walmart (Bentonville, AR)
- …details who excels at prioritization and collaboration. As an Enterprise Business Services Senior Specialist II, you will respond to third-party pharmacy audit ... actions and compliance guidance to pharmacy associates. Reporting to the Billing Manager , you will communicate potential concerns, risks and trends while applying… more
- Catalyst Clinical Research LLC (Raleigh, NC)
- As a Senior Clinical Research Associate with strong Car-T/Cell therapy experience, you will monitor clinical trial programs and manage regional clinical trial sites ... input on site selection, study initiation procedures, conflict resolution, and audit responses. You will effectively communicate all relevant and important findings… more
- Abbott (Alameda, CA)
- …for diversity, working mothers, female executives, and scientists. **The Opportunity** The Senior CRA will assist in the clinical execution and management of all ... clinical sites and performing study device accountability. + Responsible for assisting senior staff in planning study conduct, designing case report forms (CRFs),… more
- United Therapeutics (Durham, NC)
- …clinical team in preparing for external audits + Facilitate GXP Compliance/QA audit activities for clinical development to include root cause analysis, corrective ... in biopharmaceutical research & development or CRO + For Senior Oversight Lead level: + 10+ years of experience...relevant clinical oversight experience as a CRA and/or Clinical Manager in the biopharmaceutical industry + Experience with quality… more
- Danaher Corporation (Chaska, MN)
- …a part of the CCIA Clinical Affairs team and report to the Clinical Affairs Manager , who is responsible for managing the clinical operations for a cardiac study. If ... (SSF), and Investigator Site Files (ISF) are maintained and kept current; assist in audit readiness and preparation. + Contribute to case report form design and EDC… more
- BeiGene (San Mateo, CA)
- …study-specific monitoring issues * Provide direct support to the Clinical Study Manager by assisting with monitoring visit report review and other managerial tasks ... audits/inspections preparation/responses and quality issues, as needed, and follow-through with audit /inspection findings to resolution as it related to involved CRA… more
- Nanobiosym, Inc. (Cambridge, MA)
- …help the company scale up its operations. Nanobiosym is looking for a Quality Manager for its High-Complexity Testing CLIA LAB. The role and requirements are below. ... The CLIA (Clinical Laboratory Improvement Amendments) Quality Manager will provide quality and compliance oversight to the Nanobiosym diagnostic testing laboratory.T… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …by staying **True to Life.** **Job Description** The Clinical Quality Assurance Manager reports directly to the Executive Director of Clinical Quality Assurance and ... Templates). + Lead or assist with the implementation of Quality processes audit and inspection readiness activities to ensure clinical studies are conducted in… more
- Frontier Medicines (Boston, MA)
- Join us as the Senior Manager /Associate Director of Quality Assurance at Frontier, where precision meets purpose. In this pivotal role, you'll oversee GCP/GLP ... commercialization. + Coordinating internal and external quality audits and preparing of audit reports, corrective action plans and follow up updates. + Ensure… more
- BeiGene (San Mateo, CA)
- …will serve as a GCP compliance expert to the organization. Additionally, Manager , GCP Compliance will assist with proactive and continuous process improvement, ... well as assisting with the effective resolution of deviations, audit and regulatory inspection findings. This position requires the...Tracks KPIs and prepares reports to be presented to senior management. + Stays abreast of new and revised… more
- ThermoFisher Scientific (Santa Clara, CA)
- …+ Drives resolution to quality issues as needed and communicates internally to senior leaders and to diverse audiences in an effective manner. Solves problems in ... + At least 2 years of experience leading a multi-site organization + Audit (ISO9001 or similar) or inspection (FDA or similar) management experience + Customer… more
- Medical Mutual of Ohio (OH)
- …with a strong focus on member experience. Conducts outreach to Pharmacy Benefit Manager (PBM) for refills, claim reprocessing and to members to provide status of ... Part D and Part B inquiries, grievances, and CTMs, updating tracking documents, audit research items, and marketing material reviews. . Assists in outbound calls to… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Development Leadership teams, as appropriate and as needed + Interact with senior Oncology Franchise leadership teams to ensure Quality is consistently and ... in support of a proactive quality risk management process. Interact with the audit function. The respective Data Management groups and respective CROs in order to… more
- Astellas Pharma (Westborough, MA)
- …continuous improvement opportunities for these programs. + May assist with the Internal Audit program for the organization, serving as an assistant auditor to help ... satisfy new compliance requirements or improve work practices. + May assist senior QA staff in oversight of contract manufacturing organizations (CMO), monitoring… more