- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(KQI) (eg Quality Plan status, metrics, trends in deviations and Quality Events, inspection/ audit findings, inspection/ audit CAPAs). Support MA/PV health ... Quality Plan status, metrics, trends in deviations and Quality Events, inspection/ audit findings, inspection/ audit CAPAs).Responsibilities- Leadership/… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is ... the scrutiny and questioning of a sponsor pre-approval inspection.Post inspection, audit , quality review, investigational panel or other identified sources,… more
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management ... and could include all or some aspects of the Quality function.The Product Development QA Manager provides...support to internal, client, and regulatory audits.Engage in monitoring quality systems to maintain awareness and audit /inspection… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …timeline, budget and objectives set forth by the Study team. The Clinical Study Manager role is primarily a tactical study delivery role, reporting into an Associate ... in accordance with DS standards. Act as the project manager of the clinical study team to liaise and...functional integration and delivery of items (eCRF, EDC, IXRS, Quality Oversight Plan etc) per the study plan. Oversee… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Unit Team culture. Service as a primary contact with Legal and Quality Assurance regarding records Retention and Training Coordination. Demonstration and successful ... processes associated with legal and financial requirements including handling internal audit . Work closely with IT regarding implementation and utilization of new… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with global Quality departments to review global policies, inspections and audit CAPAs, and vendor audit documentation.- Author, update and maintain Global ... policies and procedures in collaboration with global DX and global Quality departments. Evaluates key performance indicators and participates in SDLC Lessons… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key internal and external ... abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study delivery role, reporting… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …expectations for products. The incumbent is responsible to adhere and maintain Quality Management System and GMP Compliance Programs to assure product quality ... and supporting complaint and recall programs, . This position interacts with Quality Assurance (QA) sub-functional and cross-functional teams, as well as Contract… more
- Aequor (Bothell, WA)
- …Description: PURPOSE AND SCOPE OF POSITION: This position reports into the Quality Assurance department and is responsible for assisting with the implementation and ... Experience: Eight (8) or more years of relevant work experience in pharmaceutical quality operations, quality assurance, quality systems, and/or IT… more
- SSS Company (Atlanta, GA)
- …ointments, creams, tablets. Job Description Our company is seeking an on-site Quality Assurance/Regulatory Affairs Manager to join our company to oversee ... regulatory and quality assurance duties. We are looking for an individual...quality through process evaluation, product inspection, packaging inspection, audit and annual product review. Performs failure investigations, initiates… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …performance and other areas. You will report to the Manager , Microbiology.Job ResponsibilitiesProvide general oversight, plan, organize, direct, and evaluate ... tasks.Develop the performance/talent of direct reports.Schedule, staff, train, and audit multiple activities for responsibilities.Ensure completion of all testing,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …appropriate, provide support for GCO process improvement activities, projects, inspections and/or audit findings resulting in the need for either a new procedural ... as appropriate.Work with the Global Training Office to create a CRO Alliance Manager account within our learning management system (LMS) and maintain the curriculum… more
- Eisai, Inc (Nutley, NJ)
- …to standards.Oversee regional security vendors.Prioritize risk-based reduction efforts. Manager investigations.General Compliance Activities:Maintain an inventory of ... compliance issue resolution.Report compliance risk levels to key stakeholders.Coordinate audit readiness and resolution.Align IT compliance budget with risk appetite… more
- Catalent (St. Petersburg, FL)
- …and metrics, including DRB (Deviation Review Board) presentation.Effective communication with Quality Assurance Supervisor and Manager regarding status of daily ... I. Department Overview: The Quality Assurance Department is responsible for providing leadership...solutions. Furthermore, this position will participate in the internal audit program, customer audits and may assist with Supplier… more
- Novo Nordisk Inc. (WA)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific… more
- TEAM QUALITY SERVICES INC (Auburn, IN)
- …lead multiple inspection team members.-- Provide team member feedback and recommendations to manager . Team Quality Services is an Equal Opportunity Employer. All ... Description:About Team Quality Services - https://teamqualityservices.comFor over 25 years, Team...Ensure successful execution of inspection projects at assigned locations.-- Audit and assess risks on new and ongoing projects.--… more
- Novo Nordisk Inc. (Minneapolis, MN)
- …relationships include various interactions with customer Executives, Medical, Pharmacy, Quality , Health Economics and other key personnel, organizations and ... with field sales forces are accomplished. Essential Functions Regional account manager (ram) coaching: Ensure that RAMs understand their level of accountability… more
- The Cigna Group (Houston, TX)
- **Job Summary:** The Medicare Coding Quality Review Audit Manager is responsible for day-to-day oversight of the Risk Adjustment coding quality assurance ... day-to-day solutions are performed as designed + Works closely with Quality Review Audit Advisor to ensure Risk Adjustment coding activities performed by their… more
- Bank of America (Charlotte, NC)
- Data Quality (DQ) Audit Team - Audit Manager Charlotte, North Carolina;Plano, Texas **Job Description:** As a member of the Data Quality (DQ) ... and accurately). Also, will work with team to provide input to draft quality audit reports and supports sharing audit results with business leaders.… more
- Bank of America (East Hartford, CT)
- Audit Manager - Quality Assurance Reporting and Analytics Atlanta, Georgia;Stamford, Connecticut; East Hartford, Connecticut; Dallas, Texas; Providence, ... it is executed in a timely manner and conforms with quality standards, audit policies, and procedures * Assesses impacts to business processes, controls,… more
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