- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …remediations and risk management in close collaboration with the organization's quality management system , to assure robust knowledge transfer and ... product profile to ensure appropriate management review of all quality and compliance related topics including the review of Key Quality Indicators… more
- Tris Pharma (Monmouth Junction, NJ)
- …Located in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager, Quality Management Systems (QMS). Summary:The Manager, Quality ... incumbent uses systems thinking and a holistic systems -based approach to drive compliance and assess... principles in the design (and resolution) of key quality management system elements to… more
- Eisai, Inc (Nutley, NJ)
- … compliance activities, maintain accurate documentation, and evaluate new system impacts. Organizational management involves strategic alignment, coaching, ... Americas business. You oversee business continuity, disaster recovery, and crisis management , while also educating end-users on compliance requirements.… more
- Merck & Co. (North Wales, PA)
- …to assess effectiveness-Partners with the Quality & Standards team and Compliance to enable compliant processes and systems and appropriately manage risk. ... culture change in the organization toward principle-based global processes and a quality systems mindset for key activities. Enables the awareness,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will provide strategic direction and leadership for the investigations management system . Working closely with the Quality Senior Manager, this position will ... the Quality Associate Director to co-lead the deviation investigations management system . Ensure alignment with GMP regulations and organizational objectives… more
- Catalent (St. Petersburg, FL)
- …employee. Compliance Manager is responsible for providing Leadership and Quality Assurance Management support within Catalent's St. Petersburg site. The ... committed to a Patient First culture through excellence in quality and compliance , and to the safety... Quality aspects including but not limited to Quality Systems , Finished Product Batch Release, Training,… more
- Aequor (Seattle, WA)
- …sources and conduct data verification processes to ensure accuracy and integrity. Lead quality system document review and routing. Follow up with reviewers and ... Job Title: The Data Stewardship and Compliance Business Analyst Location: Seattle-Dexter, WA*Hybrid Top Skills:...will benefit from a strong understanding of working within quality document systems and managing the on-time… more
- Novo Nordisk Inc. (Boulder, CO)
- …position is also responsible for supporting other processes in the Novo Nordisk Quality Management System as well as driving continuous improvement ... Develops and executes regular surveillance, follow-up, and reporting program to ensure process compliance System Management : Acts as SME and local Super… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …allow access to unapproved medicines for patients with unmet medical needs.- Quality Management and Continuous Improvement: Provide guidance to teams during ... with legal and compliance as required. Proactively collaborate with other GxP quality representatives and act as QA point person for US and EU Medical Affairs… more
- Merck & Co. (Rahway, NJ)
- …products with other pharmaceutical companies); and 3) Ensuring that essential elements of the quality management system are in place for studies conducted in ... in outcomes that demonstrate the Company's commitment to regulatory compliance . Ensures that a cross-functional team (eg Quality...clinical development programs, clinical trial processes as well as quality management systems and … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Public Affairs (MAPA), Pricing & Contracting Operations and Reimbursement (PCOR) Account Management , the SME for Medical Review Committee, Compliance , Legal, ... system is accurate and all requirements for downstream systems are met Must be able to look at...some SQL or programming skills Good knowledge of Account Management for Market Access accounts, Health systems ,… more
- Merck & Co. (North Wales, PA)
- … Assurance Operations team, the Associate Director Quality Engineering & Quality Assurance is responsible for independent compliance support of Medical ... includes, but is not limited to: Reporting to Senior Management of the Medical Device and Combination Product (MDCP)...regulatory filings and audits of data, policies, procedures, and systems to ensure compliance with Medical Device… more
- Catalent (Philadelphia, PA)
- …and Compliance Quality Assurance, and Validation Quality Assurance. Management responsibilities include professional development, performance appraisals, ... to build, monitor, and sustain a robust and effective quality system that delivers reliable, high- quality... Quality is responsible for providing leadership and Quality Management support within each of the… more
- Catalent (Philadelphia, PA)
- …Supervisory experience is preferred Good computer skills, knowledge of MS Office and Inventory Management system are a plus Basic knowledge of Lean Six Sigma ... quality , and/or distribution quality , including quality oversight for material management of materials...committed to a Patient First culture through excellence in quality and compliance , and to the safety… more
- Catalent (Philadelphia, PA)
- …documented in the batch record match those that are entered in the Inventory Management System . Other duties as assigned. The Candidate Highschool diploma or ... committed to a Patient First culture through excellence in quality and compliance , and to the safety...environment.Good Computer skills. Knowledge of MS Office and Inventory Management system are a plus.Knowledge of the… more
- Catalent (Manassas, VA)
- …years of experience in regulated environment is required. Knowledge of GMP and Quality systems ; Ability to read and follow documents (Standard Operating ... quality standards procedures and policies. Inform the QA management if any out of specification or any deviations...any other standard Catalent complies with; Responsible for ensuring compliance to FDA and cGMP standards for Quality… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for trends, and variances to ensure acceptable business practices, procedures and compliance have been followed.- Contract Management / Finance Liaison/ Internal ... developing collaboration site, internal process improvement, developing business process and system integration. Contribute and execution of DSI Tech Unit strategic… more
- Novo Nordisk Inc. (Phoenix, AZ)
- …and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM) principles and tools; executes activities relevant to ... rights and wellbeing; data reliability; scientific integrity; regulatory and process compliance ) for monitoring and site management activities. Takes ownership… more
- Merck & Co. (Rahway, NJ)
- …execution of capital and non-capital improvement projects, and the automation system assets spanning production, utility systems and associated infrastructure.- ... of relevant experience Required Experience and Skills: Experience with Environmental Monitoring Systems (REES or other EMS), including system upkeep and the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …agreements across a broad spectrum of external entities with a focus on budget, quality , compliance and in alignment with business needs Serve as a subject ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....Associate Manager will support CMR's partnership and alliance contract management strategy with a focus on: Partnering with stakeholders… more
