- Daiichi Sankyo, Inc. (Bernards, NJ)
- …The Manager, Internal Process Audits is responsible for end-to-end GxP relevant audit activities that encompasses the internal systems and processes of the Daiichi ... appropriate for the area of GxP audits assigned.Responsibilities:Execute the audit program for internal systems as applicable for the...of GxP audits assigned in alignment with the Master Audit Schedule using a risk-based approach to ensure the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Engagement folders - Establish and manage the monthly HCP Engagement Folder audit process, to ensure information is documented and reported timely.Folder Audit ... are uploaded into the appropriate section of the folder, audit check list is completed and signed by appropriate...list is completed and signed by appropriate parties.Conduct the audit and present any findings to DSI Planners for… more
- Formation Bio (New York, NY)
- …play a key role in maintaining accurate financial records, preparing audit -ready schedules, and driving process improvements that enhance scalability and ... of payroll and equity administration with the expertise needed in accounting, audit readiness, and treasury. The Senior Accountant will help ensure Formation Bio's… more
- Aequor (South San Francisco, CA)
- …reuse, search and discovery, lifecycle management, performance tracking, and audit readiness. You will work cross-functionally with content strategists, regulatory ... personalization, AI/ML classification, and dashboard reporting. Regulatory Support & Audit Readiness Ensure metadata compliance with regulatory standards and… more
- Eisai, Inc (Nutley, NJ)
- …and execution of the global Clinical Quality Assurance (CQA) strategy including audit and inspection management, issue management and oversight of the Quality ... Clinical Quality Assurance (CQA) strategy for the country/region in scope (including audit and inspection management, issue management, and oversight of the quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Affairs team, ensuring collaboration with other GxP QA functions (eg, GMP/IMP QA, Audit and Compliance, QMS QA, Development QA, and PVQA) to address GxP-related ... study/program-specific quality plans for proactive quality management.Collaborate with the audit function, Data Management teams, MA stakeholders and CROs to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …transfer of PV Business in case of Product Divestment. Collaborate with DSI audit groups to ensure comprehensive auditing of Business Partners as required to assure ... compliance with PV agreements.Participate in audit and inspection readiness activities. Provide input for re mediating PV system deficiencies cited in audit… more
- Eisai, Inc (Nutley, NJ)
- …coverage) for a marketed product across all relevant insurance lines; Lead audit calculations for premium adjustments; Manage the end-to-end process of claim ... and negotiate fees/services with insurance brokerOther: Manage the annual treasury audit and ensure JSOX compliance for all processes; ensure standard operating… more
- Insmed Incorporated (San Diego, CA)
- …regulatory agency inspections and vendor audits.Ability to ensure that a strategic audit plan is developed, designed and implemented, and that the activities are ... to SOPs and regulations.Oversee GCP activities (including internal or external audit observations and development of adverse trends) to ensure patient safety… more
- Merck & Co. (Durham, NC)
- …Safety guidelines are followed and participates in divisional Safety Audit activitiesAssists in deviation investigations for maintenance instruments, equipment, and ... systems. Position Qualifications: Education Minimum Requirement: Bachelor's Degree in Engineering, Science or related fieldRequired Experience and Skills: Eight years of experience with an Engineering or production and/or calibration and/or maintenance… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to develop professionally.Support investigation efforts as required.Responsible for audit preparation and participation.RequirementsHS Diploma required with 8-10 ... Years Biotech/Pharmaceutical experience or equivalent industry experience. ORBachelors degree required in Life Sciences or Engineering, with 4-6 years Biotech/Pharmaceutical experience or equivalent industry experience.Interpret a variety of instructions… more
- Merck & Co. (Rahway, NJ)
- …of CQO as appropriate. The CQOM will facilitate and oversee the responses to audit and inspection observations as appropriate.- In addition, the CQOM will work with ... peers to analyze data across therapy areas in order to identify signals and trends and will then develop and implement appropriate process improvement strategies.In partnership with the CQOL, the CQOM will develop skillsets in order to be able to recognize and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and external environments at a global and regional level as required.Support audit and inspection readiness activities as a subject matter expert. This individual ... will be accountable for maintaining a state of inspection readiness and in turn, act as key representer of DS in inspections/audits (presentations of signal process, coordination of document requests) throughout the year. Additionally, this individual will be… more
- Merck & Co. (Rahway, NJ)
- …switches, dry-run modes, and time-limited actions. Ensure observability with audit logs, dashboards, and feedback loops. Collaborate across cybersecurity domains ... to embed AI and automation into enterprise defense.Qualifications:Required Bachelor's degree in Computer Science, Cybersecurity, Engineering, or a related field. 5+ years in cybersecurity engineering, automation, or applied AI. Proficiency with KQL and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …developing and overseeing the implementation of CAPA in relation to sponsor's audit or regulatory inspections and ensure lessons learned are developed and ... shared.Support the Study Management Group Heads and Vice President of Clinical Operations and above in establishing and maintaining an organizational structure and staffing to effectively accomplish the Clinical Operations goals and objectives.Responsible for… more
- Twist BioScience (South San Francisco, CA)
- …facilities engineers as necessary. Manage vendor services at local facility and inspect/ audit facility for cleanliness and proper 5S efforts. Work with Supply Chain ... to manage moves, offsite storage and other logistics functions. Work closely and cooperatively with Engineering and Operations Departments to maintain and PM all lab support hardware; for example, vacuum, clean dry air, and UPSInterface with Federal, State,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to develop professionally.Support investigation efforts as required.Responsible for audit preparation and participation.RequirementsHS Diploma required with 4-6 ... Years Biotech/Pharmaceutical experience or equivalent industry experience OR Bachelor's degree required in Life Sciences or Engineering, with 0-2 years Biotech/Pharmaceutical experience or equivalent industry experienceInterpret a variety of instructions… more
- Novo Nordisk Inc. (WA)
- …policies and procedures; Evaluate appropriate use of resources; Review and audit expense reports Physical Requirements 10-20% overnight travel required. Development ... Of People Supervisory. Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those… more
- Eisai, Inc (Nutley, NJ)
- …of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This ... role is responsible for Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (eg US, EU… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …local MES system.Align global process strategy and data governance initiativesEnsures Audit Readiness and SupportResponsible for the site system strategy and ... managing the interdependence with site's base business.Oversee the hiring, development, and performance management of MES team.Establish key stakeholder relationships with internal and external stakeholders. Ability to interact with all levels within the… more
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