- Sumitomo Pharma (Austin, TX)
- …goals effectively. + Regulatory Engagement: Interface with regulatory authorities, including the FDA , EMA, and other global agencies, to secure trial approvals and ... protocols. + Oversee clinical trial execution, ensuring quality, patient safety, and compliance with GCP standards. + Develop and execute corporate clinical strategy… more
- United Therapeutics (Houston, TX)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... transplantation. You have extensive experience in risk management activities and GMP compliance . The Director, DPF Site Operations role is pivotal in maintaining… more
- Grifols Shared Services North America, Inc (White Settlement, TX)
- …daily activities of donor floor operations, supervising staff, and supporting compliance with regulatory and quality standards. The Senior Operations Supervisor acts ... staff during assigned shifts. + Learns and maintains thorough familiarity and compliance with all state and federal regulations, US Food and Drug Administration… more
- Kedplasma (Lubbock, TX)
- …procedure and plasma collection, including donor set-up, monitoring and disconnect in compliance with Standard Procedures and FDA guidelines, as needed. + ... scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has...needed. + Records any required documentation accurately and in compliance with company SOPs. + Maintains data integrity and… more
- Actalent (Grand Prairie, TX)
- …and over-the-counter (OTC) products, committed to quality, innovation, and compliance . We're seeking a detail-oriented and proactive Regulatory Affairs Specialist ... international markets. Key Responsibilities + Ensure laboratory practices comply with FDA , Health Canada, and international regulatory requirements + Maintain and… more
- Abbott (Plano, TX)
- …+ Ensure compliance with applicable regulatory standards (eg, ISO 13485, FDA 21 CFR Part 820) and internal quality procedures. + Participate in internal ... cross-functional projects aimed at reducing scrap, improving yield, and enhancing compliance . The ideal candidate is a data-driven problem solver with strong… more
- Biomat USA, Inc. (Odessa, TX)
- …daily activities of donor floor operations, supervising staff, and supporting compliance with regulatory and quality standards. The Senior Operations Supervisor acts ... staff during assigned shifts. + Learns and maintains thorough familiarity and compliance with all state and federal regulations, US Food and Drug Administration… more
- Abbott (Plano, TX)
- …+ Maintain compliance with applicable regulatory standards (eg, ISO 13485, FDA 21 CFR Part 820) and internal quality procedures. + Drive standardization and ... This individual will lead a team of quality professionals to ensure compliance with internal procedures, regulatory requirements, and industry standards. The role… more
- Merck (Austin, TX)
- …response to product inquiries and adverse reports in accordance with internal, FDA , CFIA and USDA regulatory policies. The successful candidate for this position ... aimed at answering customer and industry questions, monitoring protocol compliance , and summarizing results from post-approval marketing support trials specific… more
- Kedplasma (Houston, TX)
- …Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has been made to make ... product quality, and ensuring product quality. . Ensures production personnel follow compliance of all Center activities with cGMP, KEDPLASMA DCOP's and other… more