- Cepheid (Miami, FL)
- …assessment to identify and implement improvements. This position will work with the Senior Manager Quality Systems Compliance .This position is part of the ... compliance with local, state, and federal regulations and standards including compliance with Food & Drug Administration ( FDA ), ISO 13485, European Union… more
- Amneal Pharmaceuticals (Brookhaven, NY)
- …establishing new, revising and maintaining Global Quality Standards current. The Manager , Regulatory Compliance , has a 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 regarding Field Alerts responses… more
- Abbott (Pleasanton, CA)
- …allowing people to restore their health and get on with their lives. As a Senior Quality Compliance Manager , the individual will play a crucial role within ... Heart Failure organization with primary focus to maintain overall Quality Management System compliance to internal policies,...sources and proactively address regulatory, compliance , and quality issues. + Actively participate in FDA … more
- TreeHouse Foods, Inc. (Oak Brook, IL)
- …**Location:** IL Oak Brook **Job Type:** Quality **Job Posting Title:** Senior Manager , Food Safety & Quality Compliance **About Us** **:** TreeHouse ... Description:** **_About the Role:_** We are seeking a Senior Manager , Food Safety & Quality Compliance...Experience with various food processing methods and regulatory frameworks ( FDA , USDA, CFR, LACF/ACF). + Proficient in food safety… more
- Fujifilm (Morrisville, NC)
- **Position Overview** The Senior Manager , Quality Compliance is responsible for the day-to-day activities of the Pharmaceutical Quality Systems (PQS) ... this role is to also lead and develop a Quality Assurance (QA) compliance team. **Company Overview**...Requirements** + Experience in Validation, CGMP Manufacturing Operations and/or Quality oversight in an FDA regulated facility… 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 ... those of AdvaMed US. + Partner with cross-functional teams to provide compliance business partnership across FDA -regulated activities, including clinical trials,… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …solutions and services in more than 110 countries and regions. **Job Overview:** The Quality Manager will provide support to the Technical Director to ensure ... a quality professional organization, eg ASQ CQA. + 5 years of extensive quality assurance/ quality compliance experience working in a domestic and global… more
- Sumitomo Pharma (Honolulu, HI)
- …a dynamic, highly motivated, and experienced individual for the position of **Associate Manager , Compliance , Training & Strategic Alliance (CTSA), PVRM** . The ... Associate Manager , Compliance , Training & Strategic Alliance (CTSA),...and maintenance of PV staff learning plans, assisting with compliance activities, quality monitoring, management of the… more
- United Therapeutics (Research Triangle Park, NC)
- …you're passionate about pharmacovigilance. You are a team player who loves quality , compliance , finding solutions and ensuring training standards are implemented ... This role in Global Patient Safety (GPS) will focus on enhancing and maintaining quality , training, and compliance (QTC) of GPS operations and practices. They… more
- Abbott (Alameda, CA)
- …levels with our new sensing technology. **The Opportunity** This **Regulatory Affairs Manager - International Compliance Operations** will work on-site at our ... their glucose levels with our new sensing technology. This **Regulatory Affairs Manager - International Compliance Operations** will provide support for the… more
- J&J Family of Companies (Santa Clara, CA)
- …States of America **Job Description:** Johnson & Johnson is hiring for a **Sr. Manager , Regulatory Compliance - Shockwave Medical** to join our team located in ... the treatment of calcified plaque. **JOB SUMMARY** The Regulatory Compliance Senior Manager provides key strategic insight,... to manage risk and ensure a strong regulatory compliance profile. Assures quality and compliance… more
- Integra LifeSciences (Princeton, NJ)
- …material remediation experience. + Experience in implementing remediation programs, and working with compliance frameworks such as FDA , ISO 13485, and EU MDR is ... project plan; + Reporting on the sites' progress to the ECMP Project Manager ; + Being responsible for the site(s) ECMP documentation and schedule; + Coordinating… more
- Fujifilm (College Station, TX)
- …management principles. + Strong analytical and problem-solving skills. + Certifications: Certified Quality Manager (CQM), Certified Quality Engineer (CQE) or ... Quality Management Systems (eQMS)** . This role ensures compliance with **cGMP, and regulatory requirements** while optimizing eQMS...the US and Europe, including GDPR. + Expertise in FDA , cGMP, ISO 13485 + Experience with Quality… more
- ITW (Rogers, MN)
- …exceptional opportunities for personal and career development. We are seeking a Regulatory Compliance Manager whose primary role is to ensure that all industrial ... regulatory research, documentation, audits, and collaboration with engineering, manufacturing, and quality teams to maintain compliance throughout the product… more
- Katecho (Des Moines, IA)
- Surmasis Pharmaceutical - Quality Manager (M - F) | Pay Based on Experience + + Job Tracking ID: 512885-892472 + Job Location: DES MOINES, IA + Job Level: Mid ... SUMMARY We are seeking a highly motivated and experienced Quality Manager to lead our quality...ensuring alignment with both internal and external standards, including FDA , EMA, ICH, and GMP. + Regulatory Compliance… more
- Katmai (Brilliant, OH)
- **SUMMARY** 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
- Abbott (Tipp City, OH)
- …the manufacturing and distribution of product produced at the plant.** **The Plant QA Compliance Manager must be both aggressive and creative in solving problems ... functional areas of the plant comply with all GMPS, FDA regulations and other practices outlined by federal statutes...evaluate new or changed equipment or processes and resolve quality problems.** **In compliance with federal law,… more
- Hologic (Marlborough, MA)
- …and confidence. The Manager of Quality Engineering will lead quality strategies to ensure compliance with regulatory requirements and the delivery of ... Manager , Quality Engineering Marlborough, MA, United...FDA , notified bodies, and other regulatory agencies. + Quality System Compliance : Ensure adherence to applicable… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (###). **Let's realize your potential, together.** It ... This role plays a critical role in strengthening the organization's compliance posture by integrating external regulatory insights with internal quality… more
- Actalent (St. Louis, MO)
- …+ Design, implement, and maintain food safety and quality systems. + Ensure compliance with FDA , USDA, and other regulatory bodies. + Manage internal and ... Job Title: Quality Systems ManagerJob Description The Quality Systems Manager is pivotal in the...including HACCP, GMP, SQF, and GFSI. This role ensures compliance with FDA , USDA, and other regulatory… more
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