- Vanderbilt University Medical Center (Nashville, TN)
- …. The VUMC Laboratory Quality Management Department is in need of an FDA Regulatory Affairs Manager to join the team! **This position is eligible for ... Administration **Job Summary:** Leads VML's responses to the recent FDA LDT regulations. Develops a team to support our...goals and objectives. Continuously demonstrates a strong focus on quality in spite of time and other pressures. Anticipates… more
- Arkema (Memphis, TN)
- Quality & Compliance Manager Job Location:...customer. The Manager ensures that the plant maintains compliance with all FDA (drug and food), ISO, ... 21, 2024 Division: Oxygenes & Derivatives Location: Memphis Title: Quality & Compliance Manager Situation in...for drug/food products. + Hosts /Manages customer and regulatory ( FDA , ISO, NSF, etc.) audits. Other responsibilities (10%) +… more
- Amneal Pharmaceuticals (Brookhaven, NY)
- …establishing new, revising and maintaining Global Quality Standards current. The Manager , Regulatory Compliance has direct interface with Site Quality ... Description: The Manager , Regulatory Compliance , assembles a team...Functions: + Will be the contact person for the FDA and other regulatory agencies in regard to Field… more
- Olympus Corporation of the Americas (Westborough, MA)
- …audit responses, etc.). Can serve as a backup to the Global Director Quality Compliance : External Regulatory Communications. Review and provide guidance CAPAs ... If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (###). Posting Notes: || United States (US) ||… more
- Integra LifeSciences (Plainsboro, NJ)
- … Manager , Quality Operations** will manage and provide oversight on Quality Compliance for change control projects and daily operations which may include ... CMC Quality Operations. **SUPERVISION EXERCISED** Manages personnel supporting quality compliance areas including Change Control/Document Control, Training,… more
- CBRE (Concord, NC)
- Quality & Compliance Manager -...Biotech required. Previous leadership experience is nice to have. FDA , ISO, or similar quality assurance audit ... contract terms. **What you'll do** + Leads the day-to-day Quality and Compliance Team operations at one...self inspections, or any external agency inspections like the FDA . Has the responsibility to lead audits as well… more
- Reynolds American (Winston Salem, NC)
- Sr Manager Quality Compliance **Reynolds American is evolving at pace into a global multi-category business. We are on a mission to decrease the health ... **REYNOLDS AMERICAN has an exciting opportunity for a Sr Manager Quality Compliance in Winston...responsibilities will include:** + Define strategy and logistics for FDA inspections and readiness + Coordinate/Perform mock inspections and… more
- Olympus Corporation of the Americas (San Francisco, CA)
- …If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || ... outside US. The Manager , Sr. Global MDR Submission communicates with the FDA or other interested internal and external parties as needed. This position will also… more
- Keurig Dr Pepper (Frisco, TX)
- The Regional Quality Manager for DSD is responsible for...by FSMA, six sigma Quality performance and compliance to all FDA , EPA and OSHA regulations ... a strong CAPA/RCCM/RCCA program that drives site improvement in Quality and Regulatory Compliance . + Regularly audit...Regional facilities to ensure they are fully operating in compliance with KDP Policy & Procedures, FSMA, FDA… more
- Medtronic (Los Angeles, CA)
- …of the function. + Training and coaching cross-functional peers on maintaining compliance to internal and external Quality requirements and regulations in ... Have** + Experience working in a regulated industry (eg, FDA -regulated) + Master's Degree in Engineering, Quality ,...and work with development and supply vendors to ensure compliance to Medtronic requirements. + FDA regulatory… more
- Church & Dwight Co., Inc. (Fort Collins, CO)
- …impact because: Together We Have the Power to Win. Role Summary Reporting to the Senior Manager Quality & Compliance - Country Business & Product Quality ... Collins, CO leads the Water Pik organization to achieve compliance to the FDA Quality ...and abroad. Reporting Relationship: Reports directly to the Senior Manager Quality & Compliance -… more
- Olympus Corporation of the Americas (Westborough, MA)
- …The position will provide guidance, training, and coaching to team on quality compliance matters including on communication on responses. The individual ... If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (###). Posting Notes: || United States (US) ||… more
- Edwards Lifesciences (Columbus, OH)
- …lives. Join us and be part of our inspiring journey. As the **Clinical Compliance Manager ,** you will conduct audits of sites, vendors, and Clinical Affairs ... and accuracy of processes and procedures. Assess and identify compliance risk based on clinical quality data...Operating Procedures (SOP's) to Edwards Business Units to ensure compliance with FDA regulations, GCP and ISO… more
- Haleon (Lincoln, NE)
- …an official Quality Control (QC) representative of the plant during FDA , DEA and internal/Corporate Inspections. Assures plant compliance with analytical ... an opportunity to be part of something special. **The Quality Control Manager ** will plan, organize, directs...oversight of asset utilization. + Provide responsibility for other quality , product, and/or compliance activities as assigned.… more
- Abbott (Des Plaines, IL)
- …maintaining compliance to, and driving continuous improvement of, related quality assurance programs, policies, process, procedures and controls. + Manage the ... education and work experience + Minimum **5 years Related to supplied product quality within an FDA /ISO certified environment.** + Multi-tasks, prioritizes and… more
- Catalent Pharma Solutions (Somerset, NJ)
- **Position Summary:** Catalent Pharma Solutions in Somerset, NJ is hiring a Senior Manager , Quality Management Systems for the Quality Assurance department. ... the Training Department at the Somerset site. The Senior Manager , Quality Management Systems must possess expert...+ Lead audits of Catalent Somerset site to ensure compliance with foreign and FDA cGMPs, Corporate,… more
- Kelly Services (Grand Prairie, TX)
- ** Quality Manager ** **Kelly(R) Science & Clinical** is hiring a ** Quality Manager ** in northwest of Dallas, TX for a full-time, direct-hire opportunity ... **Position Overview:** We are seeking a proactive and experienced Quality and Safety Manager to lead the...operational staff. **Key Responsibilities:** + Strategically enhance and maintain Quality Management Systems in compliance with GMP,… more
- Katmai (Brilliant, OH)
- Position is responsible for the implementation, monitoring and maintenance of the Quality System in accordance with FDA Medical Device and Drug regulations. ... procedures, such as the Quality Manual and Quality System Procedures. + Ensure compliance with...and Documentation Control. + Prepare documentation and systems for compliance with the FDA requirements. + Conduct… more
- Envista Holdings Corporation (Quakertown, PA)
- …strong personal and professional relationships across the organization. **POSITION SUMMARY** The ** Quality Assurance Manager ** (QA Manager ) is responsible ... KPI reporting and driving KPIs to targets. The QA Manager is responsible for supplier quality management,...+ Stay updated with relevant regulations and standards (eg, FDA , ISO) and ensure that quality processes… more
- TestPros (Silver Spring, MD)
- …or a related field. + Certification in quality management (eg, ASQ Certified Quality Manager , Six Sigma). + Experience with electronic quality management ... Accessibility Assessment, Localization Testing, Independent Verification and Validation (IV&V), Quality Assurance (QA), Compliance , and Research and Development… more