- 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
- Mentor Technical Group (College Station, TX)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... Functions: + Provide engineering, troubleshooting support and technical expertise for process equipment and site utilities as needed. + Proactively identify… 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 ... and protocols to meet the regulatory requirements of the FDA , EMEA, Customer Specifications, and other regulatory bodies, as...units. + Oversees the plasma shipments and sample submission process to ensure accuracy and timeliness of shipments. +… 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 ... CGTO & SAP SD, MM & PP modules, regulatory compliance (such as GxP and FDA ), and life sciences Quality Management and Batch Release processes. As an SAP CGTO… more
- Lactalis American Group Inc. (Chicago, IL)
- … Engineer (Cheese, RSPC, and Powder Project Manager ) Chicago, IL (http://maps.google.com/maps?q=540+West+Madison+Street+Chicago+IL+USA+60661) * Engineering Job Type ... our company. From your PASSION to ours The Sr. Process RSPC, Cheese & Powder Project Manager ...preferred, + Minimum of 5 years of USDA or FDA regulated plant experience supporting manufacturing and utilities Specialized… more
- Lactalis American Group Inc. (Buffalo, NY)
- … Engineer (Cheese, RSPC, and Powder Project Manager ) Buffalo, NY (http://maps.google.com/maps?q=2375+South+Park+Avenue+Buffalo+NY+USA+14220) * Engineering Job Type ... our company. From your PASSION to ours The Sr. Process RSPC, Cheese & Powder Project Manager ...preferred, . Minimum of 5 years of USDA or FDA regulated plant experience supporting manufacturing and utilities Specialized… 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
- 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
- Amneal Pharmaceuticals (Brookhaven, NY)
- Description: In this role, the Associate Manager will lead and support the installation and integration of Blow-Fill-Seal (BFS) systems, HVAC units, sterilizers, and ... ensuring compliance with design specifications and operational standards. The Associate Manager will oversee technology transfer for the BFS platform to facilitate… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders **Job Summary:** The Regulatory Process Manager will be a key member of the Global Regulatory ... Affairs (GRA) Process Excellence & Analytics function, responsible for ensuring Daiichi...affairs, incl. familiarity with regulatory compliance frameworks (eg, ICH, FDA , EMA) (Required) + 2 or more years with… more
- Novo Nordisk (Bloomington, IN)
- …is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product ... The Engineering department is responsible for supporting CGMP operations through process engineering, facilities and utilities engineering, calibration, process … 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
- Takeda Pharmaceuticals (Lexington, MA)
- …the best of my knowledge. **Job Description** About the role: As the MES Manufacturing Process Manager , you will be a leader and contributor in the conceptual ... By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application… 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
- Hologic (Marlborough, MA)
- Manager , Quality Engineering Marlborough, MA, United States **Why Hologic?** Hologic empowers people to live healthier lives everywhere, every day. We are the ... diagnose and treat their patients with precision, certainty and confidence. The Manager of Quality Engineering will lead quality strategies to ensure compliance with… more
- Teleflex (Chelmsford, MA)
- Plant Manager **Date:** Jun 14, 2025 **Location:** Chelmsford, MA, US **Company:** Teleflex **Expected Travel** : Up to 10% **Requisition ID** :12097 **About ... Ensure compliance with applicable laws and regulations Issued by FDA , OSHA, EPA, and federal, state and local regulations....☐ Laboratory _At Teleflex, we follow a comprehensive hiring process . We do not accept unsolicited resumes from agency… more
- Catalent Pharma Solutions (Harmans, MD)
- ** Manager , Manufacturing Technical Operations (MTO)** **Summary:** _Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) ... 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
