- Novo Nordisk (Plainsboro, NJ)
- …projects and roles. Essential Functions + Compile and submit responses to FDA communications. MANAGER , THERAPEUTIC AREA: Compile, submit and maintain ... health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …Requirements (CDRH - Center for Devices and Radiological Health). + Proficient with FDA Requirements for biologics (CBER - Center for Biologics Evaluation and ... than 110 countries and regions. **Job Overview:** The Quality Manager will provide support to the Technical Director to...of Grifols USA. Generates records to comply with regulatory requirements , (cGMP QSR/ FDA /EN ISO Quality standards, Good… more
- Kedplasma (Copperas Cove, TX)
- …KEDPLASMA SOPs and other company standards and protocols to meet the regulatory requirements of the FDA , EMEA, Customer Specifications, and other regulatory ... within the scope of EU Good Practice Guidelines and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has...requirements . + Holds regular meetings with Quality Assurance Manager (QAM) and Center staff for revisions and updates… more
- Sysco (Hartford, CT)
- …and complexity. The Manager , Food Safety Program (Food Safety Program Manager ) oversees the implementation of the requirements , policies, procedures (SOPs), ... food safety. The Manager , Food Safety Program (Food Safety Program Manager ) oversees the implementation of the requirements , policies, procedures, programs,… more
- Perdue Farms, Inc. (Lewiston Woodville, NC)
- …Hygiene by following and ensuring strict enforcement of Perdue Farms Standards, USDA, FSIS, FDA , GFSI, OSHA and customer requirements . + Leads or participates in ... **Summary** We are actively recruiting for an experienced Sanitation Manager for our Lewiston Harvest facility. This position will... Proficiency** + Capable of incorporating applicable USDA / FDA /FSMA requirements into plant procedures as… more
- Actalent (Lawndale, CA)
- …to lead and maintain our Quality Management System (QMS) in compliance with FDA and other regulatory requirements . This role involves managing audits, overseeing ... Job Title: Quality Manager Job Description We are seeking an experienced...Lead and maintain the company's QMS in compliance with FDA and other regulatory requirements . + Manage… more
- Boehringer Ingelheim (St. Joseph, MO)
- …ensure the project team meets US requirements in development activities. The manager will be responsible for FDA meetings and submissions for their assigned ... (key account management). + Ensure a balanced relationship with the authorities. ** Requirements ** Manager + Advanced degree (Doctor of Veterinary Medicine or… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …& Regulatory Adherence:** + Ensure all SAP CGTO solutions comply with relevant regulatory requirements , including GMP, FDA 21 CFR Part 11, and other applicable ... aspirations. Join Gilead and help create possible, together. **Job Description** **Sr Manager , SAP CGTO Solutions Architect** **Job Overview:** We are seeking an… more
- Abbott (Santa Clara, CA)
- …managing Regulatory Affairs resources to accomplish business and corporate objectives. Knowledge of US FDA requirements and EU MDR requirements as well as ... more years of global regulatory submission experience, with substantial knowledge of US FDA Medical Device Regulatory Requirements for class III medical devices… more
- Catalent Pharma Solutions (Harmans, MD)
- **Senior Manager , Sample Management** **Summary:** _Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to ... of life-enhancing and life-saving treatments for patients annually._ _Our FDA -licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located… more