- Novo Nordisk Inc. (Boulder, CO)
- …products at CMO partners. Plan and execute qualification and operational readiness initiatives required to support clinical API internal manufacturing. ... dental and vision coverage; life insurance; disability insurance; 401(k) savings plan ; flexible spending accounts; employee assistance program ; tuition… more
- Eisai, Inc (NJ)
- …key liaison across internal teams and external partners, the Director drives operational excellence, risk mitigation, and inspection readiness while fostering ... knowledge of strategic sourcing best practices to support team execution and operational goals. Ensure adherence to ICH/ GCP guidelines, local regulations, and… more
- Merck & Co. (North Wales, PA)
- …evolution of the PSP by integrating customer insights, pain points and operational learnings into clear strategic priorities and program enhancements. This ... and ethics Demonstrated ability to create and monitor KPIs, SLAs, and program performanceAbility to plan , prioritize, execute, anticipate challengesAbility to… more
- Eisai, Inc (Nutley, NJ)
- …sourcing strategies that optimize cost, enhance vendor performance, and mitigate operational and regulatory risks. The Senior Director oversees vendor qualification, ... and compliance with ICH/GCP guidelines and local regulations, ensuring inspection readiness and adherence to corporate standards.As a key influencer, the position… more
- Insmed Incorporated (NJ)
- …ensuring compliance with document management standards, version control, and audit readiness .Coordinate the intake, formatting, and QC of regulatory documents prior ... on document management best practices.Contribute to process improvements and operational efficiencies in regulatory publishing and document management.Who You… more
- Insmed Incorporated (NJ)
- …operations, enterprise risk management, and Computer Systems Validation (CSV) program . This role will manage cross-functional teams and ensure compliance ... with regulatory requirements while maintaining operational excellence. The Executive Director, Cybersecurity & Risk Management plays a critical leadership role in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Provides operational oversight to study management personnel within assigned program (s). Provides managerial oversight to colleagues that they are directly line ... of studies. Responsible to ensure the management of assigned assets at the program level through the operational resources assigned to their program… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …based in Raritan, NJ.Role OverviewThis position will be responsible for providing operational support to the cGMP Clinical and Commercial Cell Therapy Manufacturing ... control, process improvement, process validation and data management.Partners with Operational Excellence to implement improvements.Writes, reviews, owns and updates… more
- Insmed Incorporated (NJ)
- …on Insmed therapies. This role involves developing and executing strategic plans for production, packaging, distribution, and clinical supply budgeting. The Director ... strategic leadership for Clinical Supply Chain & Logistics operations across all clinical programs and plays a key role on the Clinical Supply Chain & Logistics… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …dental and vision coverage; life insurance; disability insurance; 401(k) savings plan ; flexible spending accounts; employee assistance program ; tuition ... and frameworks for patient support field teams. This role will oversee program operations, compliance, vendor contracts and relationship management. AD will drive… more
- Insmed Incorporated (NJ)
- …clarity in goals, objectives, and expectations. Coach and develop team members. Proactively plan for the future to ensure readiness and effectiveness of the ... and research gaps. The Senior Director, Medical Services will drive operational excellence and continuous process improvements across the functions. This will… more
- Syner-G BioPharma Group (Boston, MA)
- …biopharmaceutical development services spanning early development to post-market, along with operational strategy and support. With a global team of 400 employees ... 2025 award, for the second consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and performance.Key Responsibilities Plan , lead and oversee the tactical and operational production plans for the site, in close collaboration with key ... and integrate other planners that support areas or functions and those plans into a master plant production scheduleMonitor progress-to- plan by proactively… more
- Insmed Incorporated (NJ)
- … for complex, evolving pipelines.What You'll Do: Provide strategic and operational Quality leadership for development programs from toxicology through ... lead QA CMC oversight for drug products, biologics, and combination product programs from toxicology through Phase 3. This role ensures phase-appropriate GMP… more
- Credence (Mclean, VA)
- …and national defense, managing DoW-critical workloads that enable mission success and operational superiority. You will help drive readiness , resilience, and ... Credence has an immediate need for an exceptionally skilled and highly technical Program Manager to lead a large, dynamic team supporting Department of War (DoW)… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …according to the Software Development Lifecycle (eg commissioning test Plans (CTP), Installation/ Operational Qualification (IOQ).Support updates to ... Specifications, and Qualification Protocols) with alignment to Global Procedures.Support Site Readiness of MES for FDA and/or Other Regulatory Audits /… more
- The Cigna Group (Bloomfield, CT)
- **Role Summary** The Operational Readiness Lead will support large-scale, complex, and cross-functional initiatives within US Employer Portfolio Core Solutions. ... This role is responsible for driving end-to-end operational readiness and change management across impacted...+ Proactively resolve or mitigate issues and implement contingency plans ; escalate as needed to E2E PM, projectleadershipand business… more
- Lilly (Lebanon, IN)
- …a greenfield manufacturing site, and the successful candidate will help to drive the plant operational readiness plan to enable a successful startup into GMP ... key stakeholders to deliver a fully integrated and executable plan for operational readiness . This...Management:** Assess operational risks and develop mitigation plans to support successful delivery of critical programs… more
- US Air Force - Agency Wide (Pope AFB, NC)
- …of this position is: To serve as the primary point of contact for Group Plans , Programs , and Readiness . In addition, provide assistance, and guidance, to ... Provides management for the group on matters pertaining to readiness , contingency response, plans and programs...program operations toward development and/or improvement of critical plans and programs ; Knowledge of pertinent laws,… more
- Lilly (Houston, TX)
- …an integrated project plan to prepare the manufacturing facility for operational readiness . Reporting through site operations, this role works closely with ... startup into GMP manufacturing operations. **Position Overview** The Associate Director - Operational Readiness is a key site leader responsible for developing… more
