- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …developing and executing the global GxP training strategy to ensure compliance with regulatory requirements and foster a strong quality culture across the ... lead the global GxP training strategy aligned with corporate quality objectives and regulatory standards. + Establish...training content is accurate, current, and aligned with global regulatory requirements ( FDA , EMA, ICH). **Compliance &… more
- BeOne Medicines (Pennington, NJ)
- …and release of material, intermediates and finished products under FDA /EU regulations, applicable International Regulations, BeOne processes and procedures. ... Establishes and implements QC Biochemistry procedures and supports regulatory compliance inspections. Ensures efficient and effective day to day operations of the… more
- J&J Family of Companies (Titusville, NJ)
- …Team. Team matrix interactions may include project management, finance, legal, quality assurance, quality monitoring & compliance, clinical supplies unit, ... TA strategy, regulatory affairs, data management, medical writing, biostatistics, global medical...team and be responsible for timely completion, content and quality of key documents eg clinical development plans, protocol… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …the design, implementation, and governance of global learning strategies that support regulatory readiness, operational excellence, and a strong quality culture. ... execute the global GxP training strategy in alignment with regulatory requirements and corporate quality objectives. +...Risk Management** + Ensure all training programs meet global regulatory standards ( FDA , EMA, ICH, etc.) and… more
- Bristol Myers Squibb (Princeton, NJ)
- …and CRO deliverables. + Ensure readiness for IND/IDE/PMA/510(k) touchpoints in partnership with Regulatory /QA. + Embed FDA QMSR/21 CFR 820, 21 CFR 11, EU ... GxP principles when program needs require it. The incumbent will wire in quality from the start, embedding QMSR/820 design controls, CLIA/CAP, IVDR, ISO13485, and 21… more
- J&J Family of Companies (Raritan, NJ)
- …experience within regulated industries + Strong knowledge of regulatory standards ( FDA , ISO, Anvisa, EMA) and quality systems + Experience supporting audits ... within the manufacturing team, ensuring all equipment and instruments meet regulatory standards, quality requirements, and operational efficiency. This role… more
- Actalent (Cranbury, NJ)
- …troubleshoot issues with analytical instruments and techniques. + Ensure products meet regulatory standards, in-house, and regulatory quality specifications. ... of advanced analytical techniques. You will ensure the highest quality standards and regulatory compliance in a...is highly preferred. + Current Good Manufacturing Practices (cGMP), FDA , and other regulatory requirements knowledge. +… more
- Kelly Services (Burlington, NJ)
- …from the ground up, and ensure adherence to FDA and other regulatory frameworks. You'll collaborate closely with Quality Assurance, Quality Control, ... with stakeholders during strategic planning. + Lead notifications regarding regulatory changes affecting operations. + Oversee responses and communication with… more
- Bristol Myers Squibb (Summit, NJ)
- …the SME during regulatory inspections. **Requirements** + Advanced knowledge of cGMP's, FDA , USP, MHRA, BP, EP, JP, PMDA, and DEA regulations and guidelines, as ... Advanced degree preferre d . + 7 years' relevant Quality work experience required, preferably in a Microbiology laborato...or cell therapy. + Experience in participating and supporting regulatory audits preferred: FDA , MHRA, PMDA, etc.… more
- Merck (Rahway, NJ)
- …will ensure products and processes are developed in accordance with applicable regulatory , quality , company, and customer requirements. This position will lead ... + Knowledge of US and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human… more