- Merck & Co. (Rahway, NJ)
- … and regulatory aspects of combination products.The incumbent must be able to lead cross- functional development teams within DD&T and across our company, and ... from concept generation/selection, development, verification, and validation to launch readiness: Lead the cross- functional Combination Product Working Groups to… more
- BioAgilytix (Durham, NC)
- …data integrity and compliance.Develop a roadmap for building a high-performing data management team, identifying roles in data engineering, quality , and ... That means hands-on work designing Azure Data Factory and API integrations, automating data- quality checks, and setting up clear governance so everyone knows who can… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and customer focus, for supporting and upholding processes anchored in the NN Quality Management System (QMS) across NAO thereby ensuring highest quality ... and inspections Demonstrate leadership skills via acting as project lead on cross- functional projects in the development...Quality Department as needed and assigned by NAO Quality Management Attend relevant symposia, conferences and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and NAO Quality Department as needed and assigned by NAO Quality Management Attend relevant symposia, conferences and scientific meetings, as necessary ... within the organization and function within the role of Quality Business Partner where requested by management ...the business Demonstrate leadership skills via acting as project lead on cross- functional projects in the development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …experienced quality representatives and/or contingency workers. Essential Functions Deviation Management Develops and serves as Quality Point of Contact for ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....and inspections Demonstrate leadership skills via acting as project lead on cross- functional projects in the development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulated applications meet strict regulatory requirements, industry best practices, and internal quality standards. The Lead is responsible for defining and ... Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This role collaborates with cross- functional … more
- Repligen (Waltham, MA)
- …provide training on quality system and procedures.Maintain strong cross- functional quality focus; build, maintain, and spread knowledge throughout ... OverviewWe are seeking an experienced Director of Quality candidate to lead Repligen's Waltham,...experience in a cGMP, ISO 9001, or ISO 13485 Quality Management System environment required.Minimum 5-8 years… more
- Merck & Co. (Rahway, NJ)
- …launch playbooks, knowledge management tools and training programs for site and functional teamsPartner with regulatory affairs, quality and site tech ops to ... multi-product launch manufacturing.To achieve this, this highly experienced leader will lead cross- functional launch readiness teams at each site, drive… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to issues, and demonstrated passion for creating new medicines.Leadership & People Management : Proven ability to lead cross- functional teams, manage ... operations management , tech transfer, process and equipment validation or quality management ; with a preference for Cell/Gene Therapy experienceMinimum of… more
- Merck & Co. (Rahway, NJ)
- …of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory, Operations, Non-clinical, Clinical, and other functional ... in parenteral drug product development and/or deliveryDemonstrated ability to lead cross- functional teams with proven talent development skillsets.Demonstrated… more
- Aequor (Thousand Oaks, CA)
- …compliance expectations, and quantitative / analytical troubleshooting skills. The NPI Lead will be responsible for leading cross- functional projects to ... meet NPI project milestones. Resolving issues in a timely manner and elevating cross- functional customer concern to various levels of management as appropriate.… more
- Merck & Co. (Rahway, NJ)
- …apply regulatory / compliance requirements relative to design controls and risk management activities. Lead the preparation of materials for program presentations ... product launch, and post-market surveillance.This position will interact with cross- functional development teams within and external to Device Development. The… more
- Merck & Co. (Durham, NC)
- … quality and process enhancements throughout the supply chain - Project Management Lead and sponsor all Supply Chain Logistics initiatives surrounding ... overall discard process Primary Responsibilities, Continuous Improvement and Stakeholder Collaboration Lead cross- functional teams to execute logistics / supply… more
- Merck & Co. (San Francisco, CA)
- …and Clinical Supply across all modalities. We are interdependent across our functional areas, Discovery, our Manufacturing Division Quality , and BARDS, to ... Incorporate relevant digital tools to automate and improve project/program management efficiency where relevant.Cross- Functional Team Leadership: in partnership… more
- Merck & Co. (Rahway, NJ)
- …ability to effectively communicate with stakeholders at various levels, including cross- functional teams, senior management , external vendors, and clinical ... Driving License:NoHazardous Material(s):n/aRequired Skills:Adaptability, Adaptability, Business, Business Risks, Change Management , Clinical Development, Clinical Research, Cross- Functional Team… more
- Novo Nordisk Inc. (Durham, NC)
- …to operate within compliance with a quality mindset that focuses on risk management & mitigation Lead the training & implementation of effective change ... anomaly detection and predictive maintenance, advanced control strategies for quality improvements, inventory management using predictive analytics...management Lead Support Corporate, PS AM, local IT, & local… more
- Eisai, Inc (Nutley, NJ)
- …matrix environment; strong ability to influenceDemonstrated ability to effectively lead cross- functional project teamsStrong written and verbal communication ... business decisions. Can apply financial analysis to build business cases that drive quality decision making and management processes.Travel is estimated at 30%… more
- Lundbeck (Indianapolis, IN)
- …achieve sales goals for promotedproducts within our psychiatry portfolio . Set and lead the development of area strategic direction and tactical sales plans using ... accountability, teamwork, and collaboration Leads by example and works collaboratively across functional areas by serving as a resource and by leveraging the… more
- Aequor (Houston, TX)
- M-F 1st Shift on-site 5x/week Responsible for tracking, management , and completion of Supply Chain Quality Records (such as deviations, material recalls, and ... based on identified recurring root cause. Serves as the Quality Record (PR) Subject Matter Expert (SME), Level I,...SOPs, logs, Batch Records) o Problem solving in a cross- functional setting, and participation and attendance at the deviation… more
- Merck & Co. (Rahway, NJ)
- …atmosphere, with an employee base that is distributed globally.Proven leadership and management skills with cross- functional teams, as well as inspiration and ... efficiently on regulatory obligations, compliance requirements and company strategy.Providing quality advice to stakeholders creating optimal development, commercialization, and… more
