- Catalent (San Diego, CA)
- Senior Manager , Quality AssurancePosition Summary:Catalent Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical ... regulatory compliance, and sound fiscal responsibility. The primary responsibilities of the Senior QA Manager include activities related to GMP (Good… more
- Insmed Incorporated (Bridgewater, NJ)
- …This position will be accountable for all necessary strategic planning, risk management, operational execution and communication required for the successful and ... documentation - Target Product Profile Strategic Development plans, Dashboards, Risk assessments and other key tools to improve organizational processes.Challenge… more
- Merck & Co. (Ames, IA)
- Job Description Responsibilities: The key responsibilities of the Senior Specialist can be divided in the 3 elements:Site Production PlanningIn coordination with ... logistics teams.Report on P&L and TTI metric tracking and support the Plant Manager & Finance with budget reviews.Ensure and promote compliance to company and… more
- Merck & Co. (North Wales, PA)
- …in the Research & Development organization at our company. Position Description/Summary The Senior Specialist, Project Manager is a core member of Early Drug ... strategies and execute our Company's drug and vaccine development efforts. The Senior Specialist is expected to provide project management leadership and drive… more
- Merck & Co. (North Wales, PA)
- …to work successfully in a matrix reporting structure Preferred: Certified Project Manager (PMP certified or certified in six sigma principles)Knowledge of our ... in its discretion that the nature of the role presents an increased risk of disease transmission.Current Employees apply HERE Current Contingent Workers apply HERE… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Trial Manager creates and ensures the successful execution of the clinical data management strategy for assigned trials within a specific ... and stakeholder expectations, facilitates cross-functional decision making, and performs risk management. Represents functional areas and GDMS on cross-functional… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to make a difference? The Position The CMR Business Planning & Strategy Manager will be responsible for facilitating the creation and management of financial budgets ... alignment with NNI or CMR strategies. The CMR Business Planning & Strategy Manager will need to build strong relationships with their stakeholders and/or business… more
- Merck & Co. (Rahway, NJ)
- …trial level. Primary activities include, but are not limited to: All responsibilities of a Senior Clinical Data Manager (SCDM) and a Clinical Data Manager ... direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible for executing end to end...that the nature of the role presents an increased risk of disease transmission.Current Employees apply HERE Current Contingent… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …contracting agreements. In collaboration with the Associate Director, the Associate Manager will support CMR's partnership and alliance contract management strategy ... CMR organization. This position will work cross-functionally with stakeholders, including senior leadership, across all organizations within CMR as well as… more
- Tris Pharma (Monmouth Junction, NJ)
- …in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality Management Systems ... (ie, QA Operations, Quality Control (QC), Manufacturing, Operations, Technical Services, Senior Leadership, etc.) on deviations and PQC investigations relating to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Provide timely and accurate update on the timeline, status of the projects, risk and mitigation strategy to the manager and cross functional stakeholders. ... treatment of multiple myeloma. Legend Biotech is seeking a Manager /Sr. Manager , External Manufacture as part of...driving the deliverables, managing the risks, and updating the senior leadership and stakeholders on the status and plans.… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …validation, computer system validation and calibrationPerform functional and process risk assessments in conjunction with Quality and Manufacturing subject matter ... across various product teams and global manufacturing sitesProvide updates to Senior Management on site validation status activitiesProvide validation training to… more
- Tris Pharma (Monmouth Junction, NJ)
- …an immediate opening in our Monmouth Junction, NJ location for a Senior Director, Clinical Operations.The Senior Director, Clinical Operations provides expert ... escalation of issues for trial or program level deliverables to senior management, etc.); Develops, implements, and/or manages adequate systems and procedures… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …helping to ensure that the E&CDepartment takes a holistic view of risk management, considering broad organizational priorities as well as external insights. ... Effectiveness, Clinical Operations and Marketing Effectiveness. Strong collaborations with senior leaders from Legal, Finance, Operations and Market Access as… more
- Novo Nordisk Inc. (Boulder, CO)
- …overall operation. Relationships The Technical Team Lead, API Manufacturing reports to the Senior Manager , API Manufacturing. The Technical Team Lead works with ... Team Lead, API Manufacturing acts as a delegate for the Senior Manager API Manufacturing. Essential Functions Responsible for the manufacture of oligonucleotide… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and leadership for the investigations management system. Working closely with the Quality Senior Manager , this position will ensure alignment with all applicable ... CAPA implementation. Indirectly oversee Investigations Managers, providing guidance and support. Risk Assessment and Prioritization: Conduct risk assessments to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. Summary The Companion Diagnostics (CDx) Project Manager will be responsible for ensuring that the objectives of projects are ... and are accomplished within the defined timeframe and budget. The CDx Project Manager will partner with CDx Leads & Diagnostic (Dx) Scientists to co-facilitate… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …functional team members.Maintains global integrated project plans, project timelines, risk management plans and communication plans. Resolves complex problems and ... scope change proposals and stage gate proposals for formal presentation to senior management.Is comfortable working independently within a matrix environment and can… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of R&D QA. Within assigned GPTs, facilitate the implementation of a risk -based quality management process fully embedded through trial design, execution and ... annual Quality Plan together with the supported GPTs including the quality risk assessments and inspection readiness components for the designated programs. Ensure… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Project Team, Senior Leadership, Steering Committees & Investment Governance Groups Risk Reporting: Responsible for risk management process across BRD API US ... n/a Essential Functions Business Partnering: Act as Business Support Project Manager for strategic projects & implementation Drive improvement initiatives at both… more
