- Teleflex (Morrisville, NC)
- …as required by facility requirements. * Responsible for performing all duties in compliance with FDA 's Quality System Regulation (QSR), ISO13485, the Canadian ... Clinical Affairs Manager (REMOTE) **Date:** Aug 11, 2025 **Location:** Morrisville,...difference in patients' lives. **Position Summary** The Clinical Affairs Manager will provide clinical expertise, insight, and support to… more
- BioLife Plasma Services (Raleigh, NC)
- …application is true to the best of my knowledge. **Job Description** ** Manager Trainee- Operations (Travel Program- Relocation Required)** Position is based in a ... a fast-paced career are within your reach. As a ** Manager Trainee** , you will participate in a training...skills to meet production and cost goals while ensuring compliance with regulations and BioLife SOPs. + **Travel Opportunities:**… more
- ThermoFisher Scientific (Greenville, NC)
- …which includes a drug screening. **POSITION SUMMARY** The Sterility Assurance Manager is accountable for sterility assurance across site and will own/promote/define ... (ie new lines/processes) + Implementing standard methodology (ie ensuring understanding / compliance with updated Annex 1 - leading the transition and any risk… more
- ThermoFisher Scientific (Greenville, NC)
- …platform compliance with healthcare regulations including HIPAA, CLIA, IVDR, FDA , and GLP. + Work cross-functionally with product management, R&D, Commercial, ... Practices (GMP) Safety Standards, Office **Job Description** **Job Title: Senior Manager , Platform Engineering** Role Summary Lead development of our next-gen… more
- Novant Health (Charlotte, NC)
- Job Summary The Cell Processing Lab Manager is an integral leader within our growing cross-market Transplantation and Cellular Therapy Program. + Oversees all ... compliancewith regulatory entities including FACT, CLIA, NMDP, CIBMTR, and FDA . Responsible for qualification, validation, auditing of all critical… more
- Mentor Technical Group (NC)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With… more
- ITW (Washington, NC)
- …and motivates team member engagement to identify effective solutions for scrap reduction. Compliance /Certification + Maintain the FDA QSR / ISO 13485 - compliant ... with the assigned location(s). The individual will be responsible for compliance /certifications, complaints/corrective actions, and for the financial aspect of the… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …for managing all aspects (ie quality systems, documentation, laboratory operations, compliance , training, staffing and budgetary needs, etc.) of the Quality Control ... Control business unit (quality systems, documentation, laboratory operations, overall compliance , oversee department budget, employee relations,etc.). + Follows cGMP… more
- Grifols Shared Services North America, Inc (Jacksonville, NC)
- …teams of needed updates/changes **Additional responsibilities:** + Represent R&D Compliance in professional and industry organizations. **Knowledge, skills, & ... abilities:** Knowledge and understanding of FDA regulations for the biotechnology and pharmaceutical industry. Understanding...to evaluate complex issues and meet deadlines to ensure compliance , as well as business timelines to accomplish company… more
- Sumitomo Pharma (Raleigh, NC)
- …oncology, and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and ... (written, verbal, electronic, etc.) that an employee encounters is considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable… more