- Merck & Co. (Rahway, NJ)
- …Quality Agreements.Design and build Business Continuity Process and Quality Risk Assessment Module in Reliance.Implement standard Supplier Qualification ... Director will report to the Animal Health Global Quality Lead for Compliance and Technical Support and...decisive in an ambiguous environment.Experience and ability to achieve compliance goals through a risk -based approach with… more
- Merck & Co. (Rahway, NJ)
- … digital solutions and integrations, delivering improved user experiences and streamlined risk assessment processesCollaborate with EIT Product Line Leads and IT ... platform evolves to meet future organizational needs and industry best practicesPartner with Risk & Compliance colleagues to enhance the supplier risk… more
- Merck & Co. (Rahway, NJ)
- …exploring alternative ways to view and solve problems to achieve results Drive proactive risk management activities, including risk assessment , risk ... strategic direction for a global, cross-modality technical team. The Director will lead a team of technical experts responsible providing Center of Excellence… more
- Formation Bio (New York, NY)
- …guidelines. Expertise in Quality Management Systems (QMS). Extensive knowledge of quality risk assessment and management methodologies, with a successful track ... you will establish and manage the organization to ensure our organization's compliance with the highest standards, including Good Manufacturing Practices (GMP), Good… more
- Merck & Co. (Rahway, NJ)
- …Data Analyst to support the R&D efforts related to the Insider Risk /Trade Secret (IR/TS) program through advanced data analysis and strategic collaboration. This ... delivering key metrics. Under the direction of the group lead , the successful candidate will manage day-to-day program activities,...change in how we do our work Contributes to assessment of current and future information needs Strong commitment… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Medical Review oversees a team of Medical Reviewers responsible for Medical Assessment of Individual Case Safety Reports and other safety reports pertaining to ... sources. The Director is responsible for mentoring coaching and meeting the compliance requirements for the Medical Review Team. Relationship Reports directly to… more
- Merck & Co. (Rahway, NJ)
- …drug product, finished goods including combination products, and samples. Drive proactive risk management activities, including risk assessment , risk ... strategic direction for a global, cross-modality technical team. The Director will lead a team of technical experts responsible providing Logistics and Distribution… more
- Merck & Co. (Rahway, NJ)
- …for new product introductions and technology transfers across the network.Drive proactive risk management activities, including risk assessment , risk ... and execution, along with leadership skills to shape the technical capabilities lead a global, cross-modality technical team.The Associate Director will lead … more
- Merck & Co. (Rahway, NJ)
- …blisters) meet safety, efficacy, quality, and robust supply standards. Drive proactive risk management activities, including risk assessment , risk ... and strategic direction for a global, cross-modality technical team. The Director will lead a team of technical experts responsible for technical leadership of key… more
- Merck & Co. (Rahway, NJ)
- …and responses (IND and BLA) and interacting with Health Authorities. In-vitro immunogenicity assessment , with focus on risk assessment for biologics and ... leader with expertise in biological characterization and structure function assessment of biologic modalities (eg mAb, antibody-drug conjugates, fusion proteins,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere to programming standards and ... experience, the ability to manage and coach people, and the capability to lead multiple projects concurrently are crucial for this role. Advanced knowledge of Data… more
- Merck & Co. (Rahway, NJ)
- …exploring alternative ways to view and solve problems to achieve results. Drive proactive risk management activities, including risk assessment , risk ... cross-modality technical team. As an individual contributor, the associate director will lead cross functional teams.- The leader will be responsible for executing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of ICSR Verification teams, ensuring efficient operations for case processing and assessment . Serves as expert regarding case processing issues and provides support ... working relationships within Intake and Triage, Medical Review, Submissions and Compliance , Global Safety, and centralized teams (eg, Training and Documentation,… more
- Merck & Co. (Rahway, NJ)
- …Line Engineering, Clinical Judgment, Communication, Flux Analysis, Human Health Risk Assessment , Innovative Thinking, Interpersonal Relationships, Mammalian Cell ... challenges across projects and functional teams, in a fast-paced, multidisciplinary environment. Lead the development of robust and scalable upstream processes for… more
- Merck & Co. (Rahway, NJ)
- …and documentation of all stages of cell culture process commercialization. Risk assessment , control strategies, process comparability reports, Process ... second generation process development and health authority licensure.- - You'll lead the charge in transforming our late-stage pipeline into reality bringing… more
- Merck & Co. (Rahway, NJ)
- …Maintains a state of inspection readiness. Performs proactive resourcing planning and risk assessment strategies. Advances a culture of scientific excellence, ... and microbiological release of pipeline products.- The director will provide guidance, lead activities, and strengthen a team of microbiologists whose roles include… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …is role is responsible for partnering with DS internal senior stakeholders to lead , assess, develop, negotiate and execute strategic sourcing activities (both US and ... Brand application.Responsibilities:- Leads all strategic sourcing efforts from vendor assessment , RFP, negotiation, award and contracting with senior business… more
- Merck & Co. (Rahway, NJ)
- …The role will also be responsible for proactive resourcing planning, risk assessment strategies, and budget management as necessary.Primary Responsibilities: ... this role, the Director of the Raw Materials and Medical Devices will lead a team of approximately 10 specialists and scientists supporting excipients, package… more
- TD Bank (New York, NY)
- …following: + Serve as Compliance lead for managing and facilitating the US Compliance Risk Assessment , reporting to the US Head of Compliance ... + Manage the Compliance Risk Assessment framework to ensure the applicable regulatory compliance...through concise and clear messaging; ability to influence and lead at a senior level + Ability to work… more
- American Express (New York, NY)
- …culture of integrity and effective second line independent Compliance oversight. The Director, Compliance Risk Assessment Program, is a key member of the ... Management team responsible for designing, governing, and overseeing the enterprise-wide Compliance Risk Assessment (CRA) framework. This role supports… more
