- ThermoFisher Scientific (Greenville, NC)
- …that all Operations staff are adequately trained in compliance with regulatory standards and company procedures, fostering a culture of continuous improvement ... collaboration with subject matter experts. + Ensure training programs meet regulatory requirements and company standards. **Training Delivery:** + Conduct training… more
- ITG Brands (NC)
- …and Product data management + Manages and maintains material/product regulatory compliance documentation in central specification system ensuring record completion ... BoMs and specifications to production facilities to assure compliance with regulatory requirements and accuracy and integrity of all product specifications. +… more
- ThermoFisher Scientific (Greenville, NC)
- …and implement systems to achieve process improvements and efficiencies. + Coordinate regulatory inspections performed by the FDA , MCA, and other agencies. ... with clients on agreements and resolving significant validation, product, and regulatory issues. + Prepare, review, and approve production, validation, and audit… more
- ThermoFisher Scientific (Greenville, NC)
- …employee engagement, safety performance, and ensuring adherence to all regulatory control and documentation procedures. **Role and Responsibilities:** . Help ... changing priorities. . Ensures production operations are properly controlled and regulatory compliance requirements are met by ensuring batch documentation is… more
- Cognizant (Wilson, NC)
- …This leadership role is responsible for ensuring validation strategies align with regulatory expectations and project goals, while mentoring a team of validation ... and implement validation strategies in alignment with quality standards and global regulatory requirements. + Serve as the primary point of contact for… more
- Fujifilm (Research Triangle Park, NC)
- …**Job Description** Major Accountabilities: + Dispositions manufactured materials, ensuring regulatory compliance and patient safety + Determines batch impact and ... investigations are complete, clear, and written to support Customer and Regulatory acceptance + Provides timely communication and responses to internal and… more
- Norstella (Raleigh, NC)
- …ensuring the integrity and reliability of insights provided to clients while adhering to regulatory requirements such as HIPAA, GDPR, and FDA RWE guidance. + ... requests into structured queries, ensuring that extracted data aligns with research, regulatory , and business objectives. This role is critical in ensuring our… more
- ThermoFisher Scientific (Wilmington, NC)
- …site selection, verify timely collection of essential study documents, such as regulatory and ethics committee documents for submission, and by controlling that all ... and ensures that essential document quality meets the expectation of Regulatory Compliance Review. Ensures timely regulatory submissions (if appropriate)… more
- Chiesi (Cary, NC)
- …created position will initially focus on pre-launch preparation in anticipation of FDA approval of our PAH/PH-ILD collaboration asset. They work closely with ... Compliance & Policy Adherence + Ensure adherence to corporate policies, regulatory standards, and expense guidelines. Maintain accurate documentation and stay… more
- ThermoFisher Scientific (Wilmington, NC)
- …timelines and budget, and in alignment with applicable SOPs and regulatory requirements. Successful candidates have extensive experience driving global clinical ... all start-up activities and ensures that timely ethics committee and regulatory submissions (if appropriate) are addressed. + Ensures that essential document… more