- Grifols Shared Services North America, Inc (Jacksonville, NC)
- …of, and leads/executes regulatory strategy and tactical decisions from project inception to regulatory approval, including lifecycle management of existing ... products. Serve as a regulatory representative on cross functional project teams, applying advanced knowledge of regulations and interpretation of technical… more
- Cardinal Health (Raleigh, NC)
- …of robust stability protocols, testing procedures, and quality systems. The manager will lead cross functional collaborations and possess exceptional communication ... and skill development opportunities. + **Cross-Functional Collaboration:** Collaborate with project managers, Inventory Management, Sourcing, and other Quality Assurance… more
- Pfizer (Sanford, NC)
- …patients and physicians have timely access to the medicines they need. The Manager is accountable and responsible for leading assigned production staff to achieve ... compliant with corporate policies, plant SOPs, cGMP regulations, and FDA regulations. Participates in investigations and continuous improvement initiatives, applying… more
- Lilly (Concord, NC)
- …make life better for people around the world. **Responsibilities:** During the project phase, the Operations Manager (OM) will support commissioning, ... manufacturing/operations. + At least 4 years of supervisory or manager experience. + Understanding of basic requirements of regulatory...of basic requirements of regulatory agencies such as the FDA , EMEA, DEKRA, and OSHA, or other similar groups… more
- ThermoFisher Scientific (Greenville, NC)
- …dose drug products from development to commercialization. **POSITION SUMMARY** The Sr. Manager , Environmental Monitoring (EM) Lab, leads all aspects of the staff and ... as a key member of the site's Management Team. The Sr. Manager provides technical and operational leadership for laboratory operations, technical support, and… more
- Sumitomo Pharma (Raleigh, NC)
- …Team meetings. + Represent PV Operations on cross-functional program and project teams; support PV Medical Safety activities on cross-functional program and ... project teams, as required. + Coordinate responses to ad...and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for… more
- ITW (Washington, NC)
- …to identify effective solutions for scrap reduction. Compliance/Certification + Maintain the FDA QSR / ISO 13485 - compliant Quality Management System, including ... + Ability to use MS Office Tools such as Word, Excel, Project (or other project management software), Access and MiniTab(R) (or other statistics software). +… more
- United Therapeutics (Research Triangle Park, NC)
- …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... ability to network, collaborate, and identify operational efficiency opportunities + Strong project management and operations skills + High attention to detail and… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …guidelines of bioMerieux's Quality System. Adhere to Regulatory requirements, including FDA , ISO, Legal, Ethical, and bioMerieux-specific procedures. + Source a ... + Design, lead, and implement cost savings projects based on a structured project /savings roadmap. + Follow current Lean and Six Sigma, Kaizen Continuous Improvement… more
- ManpowerGroup (Wilson, NC)
- …activities in the compliance program under your remit, working closely with the technical project manager to ensure tasks are completed by you and your team ... schedule. + Accountable for the delivery and execution of project work of your team. + Accountable for the...FDA and ICH guidelines. + Proficient in Microsoft Project , Word, Excel and PowerPoint. + Preferred: + Experience… more
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