- Eisai, Inc (Exton, PA)
- …systems.Reviews and approves documentation of SOPS, SDLC tasks, and other GxP Systems Quality Assurance processes for use in supporting compliance with GxP ... a repository of controlled documents related to GxP Systems Quality Assurance.Internal and External Auditing and Compliance ...environments.2+ years in a leadership role in GxP Systems Quality Assurance. Must be able to lead … more
- Merck & Co. (Upper Gwynedd, PA)
- …oncology products and supply chain design. The VCL will have major impact on cost, quality , customer service and compliance for the brands in their portfolio and ... at the place, at the right time.-The Value Chain Leader (VCL) is the primary point of contact between...and general knowledge of LEAN supply chain, regulatory, finance, quality and compliance , commercialization and life cycle… more
- Merck & Co. (North Wales, PA)
- …management concepts Experience in CDISC and ADaM standards Experience ensuring process compliance and deliverable quality Strategic thinking - ability to turn ... Preferred Skills and Experience: Demonstrated success in the assurance of deliverable quality and process compliance . Strong working knowledge of reporting… more
- Merck & Co. (North Wales, PA)
- …have experience in CDISC and ADaM standards and in ensuring process compliance and deliverable quality .Significant expertise in SAS and clinical trial ... in ensuring that project plans are executed efficiently with timely and high- quality deliverables. Serve as the statistical programming point of contact and… more
- Merck & Co. (North Wales, PA)
- …Data Management ( RDM) Strategy & Regulatory Data Standards Governance- - Regulatory Compliance and Risk Management for Regulatory Data - Direct and Indirect (eg, ... enable f uture proofing of regulatory submissions and ensuring compliance with evolving standards beyond 2025 ( ie IDMP...across different departments. Externally, this role will be a leader in advocating with trade, consortia and as appropriate… more
- Merck & Co. (Lower Gwynedd, PA)
- …a scientific leader with a passion for developing assays, delivering high- quality data, and helping teams develop a clinical assay strategy for data-driven ... - Early Development VaccinesDescriptionOur company is a global healthcare leader with a diversified portfolio of prescription medicines, vaccines, and… more
- Aequor (Aliquippa, PA)
- …partnership with 3PL local leadership team, manufacturing sites, planning, and transportation. Lead and monitor integration of SAP and LSP systems; prepare and ... dashboards, scorecards, KPIs and metrics sufficient to measure performance. Lead /participate cross-functional work streams with 3PL, accounting, corporate systems… more
- Merck & Co. (North Wales, PA)
- …Value and Implementation (V&I) teams at our Company.- VIPMs partner with the team leader to develop strategies and execute our Company's drug and vaccine V&I efforts ... their team's strategy.- The staff manager will be expected to monitor quality of project management deliverables and assign accountability for the maintenance of… more
- Merck & Co. (Lower Gwynedd, PA)
- Job DescriptionOur company is health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well as animal ... biochemistry to impact bioanalytical procedures supporting clinical studies.Responsibilities:Generation of quality experimental data to support assay development, validation, and… more
- Eisai, Inc (Exton, PA)
- …of documentation, manufacture of DS/ADI materials, and suite change-over ensuring compliance to relevant regulations. The Associate Director is also responsible to ... with other Development groups as well as with Facilities, Quality Assurance, Quality Control, Regulatory, and CMC...III and PV at CMOs at the company's discretion.5. Lead and assist in troubleshooting upstream and downstream process,… more
