- American Red Cross (NC)
- …+ Demonstrated ability to lead strategic growth, manage multidisciplinary teams, and maintain compliance with FACT, CLIA, and FDA standards. Develop new theories ... stem cell collection/processing, CAR-T support, and emerging therapies.** **Laboratory Compliance ** **- Oversee medical and regulatory standards for Cell Therapy… more
- Lilly (Concord, NC)
- …example and provide coaching to others in the areas of safety, quality , operational excellence, compliance , and continuous improvement. Direct line supervision ... / Deliverables:** **Integrity** + Leading by example with a Safety first, Quality Always mindset. Comfortable with exercising and encouraging "Stop Work Authority"… more
- Astellas Pharma (Sanford, NC)
- …QA support and oversight to internal staff and suppliers/contractors to ensure compliance with local and global quality standards, regulatory requirements, and ... will be primarily responsible for the implementation, execution and assessment of quality systems, procedures, and records to support compliant GMP operations. This… more
- Sumitomo Pharma (Raleigh, NC)
- …rigorous and innovative trial protocols. + Oversee clinical trial execution, ensuring quality , patient safety, and compliance with GCP standards. + Develop ... goals effectively. + Regulatory Engagement: Interface with regulatory authorities, including the FDA , EMA, and other global agencies, to secure trial approvals and… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …flow of materials within warehouse and manufacturing operations. This position ensures compliance with cGMP, ISO, FDA regulations, company policies, and safety ... movement. + Identifies and moves non-conforming materials while ensuring compliance with quality standards. + Ensures ...within the medical device industry, including working with the FDA regarding control of materials preferred + High level… more
- Astellas Pharma (Sanford, NC)
- …proactively assure compliance to all applicable internal, domestic, and international quality regulations. This role is the first point of contact for ensuring ... and alignment with departmental/site/global goals. + Establish and foster a cGMP quality culture that prepares the site for regulatory pre-approval inspections and… more
- Mentor Technical Group (Monroe, NC)
- …manufacturing operations activities. + Is responsible for overseeing work order activity compliance with respective regulatory requirements (ie FDA , DEA, OSHA). ... provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical… more
- Medtronic (Charlotte, NC)
- …as assigned/requested by management + All activities must be performed in compliance with the Quality System + Travel requirement (international possible): ... service metrics specific to RAS service activities + Active participation in RAS quality system. Function as a liaison between service team and the quality… more
- IQVIA (Durham, NC)
- …**CONNAISSANCES, COMPETENCES ET APTITUDES REQUISES :** + Connaissance des directives de la FDA (Food and Drug Administration) et de leur impact sur les operations + ... facilitate escalation management. **RESPONSIBILITIES:** + Ensure consistent and outstanding quality against department deliverables. + Manage customer relationships and… more
- Fujifilm (Durham, NC)
- …a risk-based qualification strategy aligned with industry guidance, the position ensures quality outcomes and compliance with health regulations to support the ... Decision Making** + This role significantly impacts operational efficiency, product quality , and regulatory compliance , directly influencing the company's… more