- Tris Pharma (Monmouth Junction, NJ)
- Sr Project Manager , Operations for Tris Pharma, Inc. to work at our Monmouth Junction, NJ loc. Lead + manage proj plans detailing milestones, bdgt, resources, ... timing + roles + responsibilities for prgms incl scale-up activities, process validation , post- validation changes + comm w/ FDA. Provide tech spt to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... trials, clinical development, and regulatory submissions. The position will perform validation of the electronically transmitted external data by ensuring all… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …CRF review, SAP development, analysis files development, statistical analysis accuracy validation , results interpretation and CSR input and review. Acts as main ... team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …CRF review, SAP development, analysis files development, statistical analysis accuracy validation , results interpretation and CSR input and review. Acts as main ... team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data.- Drug Development Strategy: Provides input to… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Provide expertise and solutions to CSV questions and issues. **Responsibilities** - Provide Validation Lead support for Daiichi Sankyo GxP and Non-GxP computer ... diseases and immune disorders. **Summary** Manage Global DX Computer System Validation (CSV) projects within Daiichi Sankyo, for Computerized Systems supporting GxP… more
- Integra LifeSciences (Plainsboro, NJ)
- …candidate will act as liaison between the organization and the supplier to lead and communicate the component/process validation requirements and ensure timely ... demonstrate proficient experience with quality management concepts, IQ/OQ/PQ process validation and manufacturing engineering to drive continuous improvement. The… more
- TD Bank (New York, NY)
- …for this role. **Line of Business:** Audit **Job Description:** The Audit Manager is accountable for overseeing the planning and execution for audits covering ... of audit documentation. Oversees findings follow up and issue validation . + Ensures audits are executed and completed in...matter areas + Adapt, promote and champion change + Lead and manage small to medium sized teams +… more
- TD Bank (New York, NY)
- …+ Generally leads a team focused on assigned audit and generally assumes the lead position on the audit, providing supervision and assignments to team members as ... status, and findings + Works at direction of Audit Manager + May perform testing procedures for more critical...in Charge on an Audit + May participate and/or lead assigned special projects + Provides feedback on staff… more
- Citigroup (New York, NY)
- …of all models for use during reviews with senior management, model validation , Citi's business and functional teams, internal/external audit, and regulatory agencies ... model projects (business requirements, data capture, model design, build, validation , implementation, and use) + Excellent communication and interpersonal skills… more
- J&J Family of Companies (Skillman, NJ)
- External NPI Site Quality Lead - 2407020010W **Description** Kenvue is currently recruiting for: **External Quality Lead -NPI** **Who we are** At Kenvue, we ... us in shaping our future-and yours. Role reports to: External Quality Manager -NPI Location: Skillman, NJ (Kenvue's corporate headquarters is currently located in… more
- Lilly (Branchburg, NJ)
- …manufacturing operations and for the specification, installation, start-up and validation support of process equipment projects. As applicable, other duties ... prepare, and review Operational SOP's and Functional Requirement Specification (FRS), lead projects activities, and represent automation group in several process… more
- Taiho Oncology (Princeton, NJ)
- Sr. Manager , Analytical Development Princeton, NJ, USA Req #362 Monday, April 22, 2024 Looking for a chance to make a meaningful difference in the oncology space? ... innovation thrives, and excellence is celebrated. As a Senior Manager in Analytical Development, you'll play a pivotal role...to drug substance and drug product, serving as analytical lead for assigned projects with the CMC team. Liaises… more
- Deloitte (New York, NY)
- Deep Learning Data Science Manager SFL Scientific, a Deloitte Business practice brings together several key capabilities to architect integrated programs that ... and enterprise value. We are hiring a Data Science Manager to support the technical design, development, and deployment...science & AI career. + Serve as the technical lead on projects to drive the technical strategy, roadmap,… more
- J&J Family of Companies (Skillman, NJ)
- …- 2407020615W **Description** Kenvue is currently recruiting for: **Distribution Center QA Lead ** This position reports to Senior Manager Distribution and ... more information, click here. (https://www.youtube.com/watch?v=XhsbOsBiX\_M) **Role reports to:** Senior Manager Distribution and Supplier Quality CQ **Location:** Palmetto, Georgia… more
- Synchrony (New York, NY)
- Job Description: **Role Summary/Purpose:** The AVP, Detection & Response Engineering Lead will be responsible for leading and driving all engineering activities for ... explore capabilities in Security Orchestration, Automation, and Response (SOAR), security validation , email security, and other areas, all while working closely with… more
- Alight (New York, NY)
- …of Be Alight. Learn more at careers.alight.com. **About the Role** Psychiatric Physician Lead of Medical Leave of Absence for The Americas will provide oversight and ... permanent restrictions. + Provides physician coverage for entire team when lead physician is unavailable (eg, PTO) **Clinical Case Management Leadership** Provide… more
- Merck (Rahway, NJ)
- **Job Description** **Position Description:** **Veeva Vault QMS Lead ** This role is positioned within the Veeva Vault Quality Platform Team, responsible for ... remains compliant as a Validated Solution through verification testing, documentation, and validation efforts + Collaborate across the Manufacturing & R&D IT Quality… more
- American Express (New York, NY)
- **Description** **You Lead the Way. We've Got Your Back.** With the right backing, people and businesses have the power to progress in incredible ways. When you join ... feels like they belong. Join Team Amex and let's lead the way together. Our industry is rapidly evolving,...as well as with oversight groups such as model validation and audit. **Responsibilities:** * Development, maintenance, testing and… more
- BeiGene (Hopewell, NJ)
- …for facility start-up and execution of cGMP purification operations. Lead implementation of innovative and cost-effective technologies, design practices and ... production schedules, quality standards, and regulatory requirements. The Purification Operations Manager will be responsible for actively directing and engaging in… more
- BeiGene (Hopewell, NJ)
- …Reports, Aseptic Process Simulation Protocols and Reports, Cleaning Validation , Process Validation (PPQ). + Lead validation activities for project ... as a point of contact with different business areas, lead and handle validation projects, ensure the...the business, which may be requested by the Line Manager , for which training and/or an explanation has been… more