- Cepheid (Miami, FL)
- …identify and implement improvements. This position will work with the Senior Manager Quality Systems Compliance.This position is part of the Quality department and ... manner with effective corrective action. Participate in external audit management (eg FDA , ISO, Danaher Corporate, foreign governments), in either a supporting or… more
- Aldevron (Miami, FL)
- …a part of the Analytical Method Validation Team and report to the Sr. Manager of Analytical Method Validation. You will assist in representing the Analytical Method ... test method validation, test method transfer, and method development.Foundational knowledge of FDA , EU, and ICH regulations related to test method validation and… more
- 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
- Cambrex High Point (Longmont, CO)
- …that all activities are in compliance with company SOPs, cGMP/cGLP standards and FDA /EU regulations. The Manager of Quality Assurance leads and mentors the ... where You Matter by applying today! Job Overview The Manager of Quality Assurance is responsible for the daily...and maintenance of procedures and policies to comply with FDA , EU, and ICH requirements applicable to site's needs.… more
- RWJBarnabas Health (West Orange, NJ)
- … with responding to/correcting medical equipment recalls/device alerts from manufactures and/or FDA + Assists Manager in giving medical equipment in-services to ... equipment. Assists with new equipment installations as assigned. + Assist Manager in maintaining and fulfilling the department/organization s regulatory requirements… more
- Kelly Services (Sacramento, CA)
- …compliance with cGMP regulations, internal quality standards, and applicable regulatory requirements (eg, FDA , EMA, MHRA). The QA Manager will lead a team in ... Kelly(R) Science & Clinical is seeking a **Quality Assurance Manager ** for **a Direct Hire opportunity** at an innovative and growing pharmaceutical manufacturing… more
- AbbVie (Irvine, CA)
- …insights to help develop high-quality jobs. Ensure jobs adhere to company policies and FDA guidance. The Sr. Manager also ensures that all SOP requirements are ... Aesthetics | An AbbVie Company Job Description The Marketing Operations, Senior Manager works cross-functionally to project manage the review process for advertising… more
- Element Materials Technology (Boulder County, CO)
- **Overview** Element Boulder has an exciting opportunity for a **Business Development Manager ** focused on driving sales and business growth within the medical ... on pulse oximetry, blood pressure monitoring, respiratory health technology, and FDA -regulated medical devices. + **Sales Expansion:** Drive profitable sales growth… more
- System One (Plainsboro, NJ)
- …and SPL). + May be responsible for managing projects, processes, or programs with manager oversight. + Knowledge of FDA and Health Canada eCTD submissions ... maintaining product and establishment registrations (drug/establishment listings) and submission to FDA databases. This individual acts as the Subject Mater Expert… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …services in more than 110 countries and regions. **Job Overview:** The Quality Manager will provide support to the Technical Director to ensure compliance of Quality ... USA. Generates records to comply with regulatory requirements, (cGMP QSR/ FDA /EN ISO Quality standards, Good Distribution Practices and Internal...with the rules and regulations of the regulatory agencies ( FDA 21CFR, PIC/s GDP & EN ISO 9001) and… more
- Kedplasma (San Antonio, TX)
- …developed and maintained. Operates within the scope of EU Good Practice Guidelines and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has been made to make ... company standards and protocols to meet the regulatory requirements of the FDA , EMEA, Customer Specifications, and other regulatory bodies, as required. + Maintains… more
- Perdue Farms, Inc. (Lewiston Woodville, NC)
- …**That's Perdue.** **Summary** We are actively recruiting for an experienced Sanitation Manager for our Lewiston Harvest facility. This position will directly report ... / GFSI requirements, and Sanitation Key Performance Indicators. The Site Sanitation Manager is also the technical liaison between the plant, corporate sanitation,… more
- Sysco (Hartford, CT)
- **JOB SUMMARY** The Manager , Food Safety Program (Food Safety Program Manager (FSPM)) is responsible for providing proactive leadership and instruction in Food ... Site(s). Sites are assigned to FSPMs based on risk and complexity. The Manager , Food Safety Program (Food Safety Program Manager ) oversees the implementation… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …aspirations. Join Gilead and help create possible, together. **Job Description** **Sr Manager , SAP CGTO Solutions Architect** **Job Overview:** We are seeking an ... & PP modules, regulatory compliance (such as GxP and FDA ), and life sciences Quality Management and Batch Release...operations, ensuring alignment with industry regulations such as GxP, FDA , and 21 CFR Part 11. Design scalable, efficient,… more
- Boehringer Ingelheim (St. Joseph, MO)
- …guidance and ensure the project team meets US requirements in development activities. The manager will be responsible for FDA meetings and submissions for their ... **Description** Manager The Manager , Regulatory Affairs (RA)...linking regulatory affairs information to internal and external stakeholders ( FDA ) to ensure sufficient and efficient communication through activities… more
- Amneal Pharmaceuticals (Brookhaven, NY)
- Description: The Manager , Regulatory Compliance, assembles a team for site-wise and/or cross departmental discussions, oversees investigation, and completes Field ... events that warrant notification to The Food and Drug Administration. The Manager , Regulatory Compliance, is responsible for leading activities for the processing… more
- Catalent Pharma Solutions (Harmans, MD)
- **Senior Manager , CAPA** **Summary:** _Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, ... 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
- Abbott (Santa Clara, CA)
- …CA currently has an on-site opportunity for a **Senior Regulatory Affairs Manager - Transcatheter** **Mitral Valve Replacement** within **Abbott Ventures** . This ... to support clinical trial activities and product launches. The Senior Manager leads project submissions for regulatory approvals and acts independently to… more
- Keurig Dr Pepper (Sacramento, CA)
- **Job Overview:** The QEHS Manager is accountable for the Quality and Environmental, Health and Safety Program at the site. Direct report to the Plant Director, the ... QEHS Manager provides site leadership in Food Safety, Quality Assurance,...six sigma Quality performance, and 100% compliance to all FDA , EPA and OSHA regulations. **Location:** This position is… more
- Cordis (Miami Lakes, FL)
- …people who keep saving lives. **Responsibilities** We are seeking an experienced **Senior Manager - Compliance, the Americas** to lead and enhance our healthcare and ... accountability across the Americas. This role is a people manager role, managing a team of 2 others. This...healthcare laws and regulations, including those enforced by the FDA and industry standards like those of AdvaMed US.… more
Related Job Searches:
FDA,
Manager,
Manufacturing Manager FDA,
Operations Manager FDA,
Process Manager FDA,
Project Manager FDA,
Quality Compliance Manager FDA,
Quality Manager FDA,
Requirements Manager FDA,
Sr Program Manager FDA