- Aequor (South San Francisco, CA)
- …search and discovery, lifecycle management, performance tracking, and audit readiness . You will work cross-functionally with content strategists, regulatory affairs, ... AI/ML classification, and dashboard reporting. Regulatory Support & Audit Readiness Ensure metadata compliance with regulatory standards and business requirements.… more
- Office of the Secretary of Defense (Arlington, VA)
- …position is located in the Office of the Assistant Secretary of Defense for Readiness (OASD(R)), within the Office of the Under Secretary of Defense (Personnel and ... Readiness ) (OUSD(P&R)) with direction from the Assistant Secretary of Defense for Readiness (ASD(R)) and Principal Deputy Assistant Secretary of Defense for … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …continuous improvement in benefit-risk evaluation, and participate in inspection readiness activities.Responsibilities:This individual will be the main point of ... 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… more
- Merck & Co. (Rahway, NJ)
- …incumbent will be accountable for the overall strategy for maintaining ongoing inspection readiness as well as preparing for, management and follow up of regulatory ... (eg QCV, HQ QCP) with an aim to increase Inspection Readiness .Leads, drives, facilitates and/or supports remediation, prevention activities as process improvement… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …annual Quality Plan, including quality risk assessments and inspection readiness components for designated programs.Ensure proactive representation of Quality ... during inspections and external audits. Ensure ongoing submission and inspection readiness for the respective Medical Affairs teams and related submissions,… more
- Genscript USA Inc. (Piscataway, NJ)
- …planning and supervision of facility routines, preventive maintenance, and operational readiness across all sites. Perform related strategic and technical work as ... assigned. Qualifications: Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Civil/Structural Engineering, Architectural/Building Engineering, or a closely related field. 4-6+ years of relevant experience in facilities/MEP engineering,… more
- Genscript USA Inc. (Piscataway, NJ)
- …to ensure supply continuity, compliance with quality and regulatory standards, and readiness for audit requirements. The estimated salary range is $80,000 - ... $100,000, based on experience. Job Responsibilities: Supervise the direct procurement team to ensure smooth daily operations and compliance with SLA and KPI targets, and effectively manage team performance. Oversee material planning for Green Channel item… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …assigned GMA plan activities, in collaboration with Sr Director.- Support medical readiness activities for market launches and life cycle management for select ... indications/projects. Gains strategic and planning alignment across regions and functions and supports review of Local Country/Regional Medical Affairs activities when applicable. Provide medical support/input into commercial and market access discussions for… more
- Aequor (Thousand Oaks, CA)
- …technical writing skills. Contribute to project workshops, testing activities, and readiness assessments to support effective adoption of ERP changes across the ... enterprise. Preferred Qualifications Prior experience in ERP implementations or large-scale systems transitions. Familiarity with the Plan to Stock functional domain. Ability to effectively collaborate and communicate in a fully remote, cross-functional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …affairs plan activities, in collaboration with Sr. Director.- Leads medical readiness activities for market launches. This includes strategic partnerships with the ... brand team, HEOR (Health Economics and Outcomes Research), RD (Research Development), FMA (Field Medical Affairs), MIE (Medical Information and Education) and global functions as necessary to create and implement strategies that support launch. Provide medical… more
- Merck & Co. (Rahway, NJ)
- …project team as a leader at the detail design phase in preparation for operational readiness .- This is an exciting opportunity to enter the team on the ground floor, ... manage a broad scope of activities, understand the RY and BPR&D facility network, learn to work in a dynamic team environment while building a collaborative network, and will require agility and flexibility to meet business needs.As leader of the Process… more
- Merck & Co. (Rahway, NJ)
- …part of the design.- Provide information and drive early alignment and readiness reviews with manufacturing partners to assess speed, complexity, and requirements ... for commercializing new products.Foster a culture of inclusion by integrating inputs and perspectives from various sources to meet customer and stakeholder needs.Build strategic partnerships with manufacturing sites and partner groupsLead, mentor, and enable… more
- Merck & Co. (Rahway, NJ)
- …part of the design.- Provide information and drive early alignment and readiness reviews with manufacturing partners to assess speed, complexity, and requirements ... for commercializing new products.Technical Expertise: Utilize extensive experience in design controls, device transfer, control strategies device risk management, and design verification testing to develop value-added solutions for medical devices and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …reduce non-conformances in supported areas by dedicatedly driving compliance.Ensure readiness of records for regulatory inspections and internal audits.Review, ... compile, and organize batch data.Review, compile, batch documents for retention and archival.Ability to utilize multiple electronic quality systems.RequirementsBachelor's degree required in Life Sciences or Engineering, with 6+ years Biotech/Pharmaceutical… more
- Merck & Co. (Durham, NC)
- …risks across supply chain, and lead data-driven improvement initiatives.Ensure readiness of E2E submission packages, proactive mitigation of regulatory technical ... queries, and contribute technical expertise during regulatory inspections.Position QualificationsB.S. in Chemical Engineering, Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field, plus minimum eight (8) years… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …closure and product release.Support regulatory inspections and audits by ensuring inspection readiness within facility and serving as an SME during the execution of ... regulatory inspections and audits as needed.Support compliance activities for site Quality Operations in accordance with Legend standards, procedures and cGMPs.Collaborate with site personnel to provide guidance and determine resolution for end-to-end… more
- Formation Bio (New York, NY)
- …payroll and equity administration with the expertise needed in accounting, audit readiness , and treasury. The Senior Accountant will help ensure Formation Bio's ... Finance function continues to scale effectively, providing critical support for the company's growth.ResponsibilitiesPayroll Ownership Own and manage semi-monthly US payroll processing via ADP Workforce Now. Partner with the People team and ADP to ensure… more
- Soliant (Browning, MT)
- …and state guidelines.Support communication development to enhance learning readiness and academic success.Manage caseload independently without supervision from ... an SLP Clinical Fellow (CF).Qualifications:Valid state licensure or certification as a Speech-Language Pathologist.Experience working with early childhood populations in school settings is preferred.Strong skills in assessment, intervention planning, and… more
- Soliant (Fort Lauderdale, FL)
- …and financial performance Ensure quality management programs and regulatory readiness across the division Qualifications: Florida Pharmacist license 5+ years ... of pharmacy management experience, including director-level leadership Proven experience managing teams of at least 3 or more employees in a retail or specialty pharmacy setting Strong background in HIV/AIDS pharmacy operations (AAHIVP certification highly… more
- Soliant (Dekalb, IL)
- …and problem-solving abilities in dynamic school environmentsBenefits:Paid orientation to ensure readiness for the school yearCompetitive pay range of $45 to $55 ... per hour, commensurate with experienceWeekly pay distributionMedical, Dental, and Vision insurance optionsAccess to direct supervisory support specializing in your discipline for continuous professional growthA Buddy Program designed to enhance onboarding and… more
