- Novo Nordisk Inc. (Plainsboro, NJ)
- …provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....in compliance with local and federal regulations (21 CFR FDA Post-Marketing), global/local SOPs, and other governing standards Maintains… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy ... evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....you ready to make a difference? The Position Developing quality and strategic objectives and strong business understanding of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Manager , Internal Process Audits is responsible for end-to-end GxP relevant audit ... for risk mitigation.Support the stakeholders in identifying and defining quality improvement initiatives for development activities / programs post internal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Manager Audits & Compliance, GCP/Document Audits supports end-to-end audit activities ... have at least 7 or more years of professional experience in Quality and clinical development in the Pharmaceutical industry, with involvement in regulated… more
- Genmab (NJ)
- …like a fit? Then we would love to have you join us!The Programming Manager supports the development of new therapies by ensuring integrity, consistency and adherence ... to standards of data and produces well-structured, high quality data summaries in tables, figures and listings for...of at least one study are in scope.The Programming Manager will support the Data Management, Statistics, Drug Safety,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global Regulatory Affairs (GRA) ... role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality , CSPV, Clinical Operations, Clinical Development, RA CMC) to keep processes,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with License Partners, Patient Support Programs, Market Research vendors, Global Quality Supply Chain, Medical Information Social Media and other suppliers.Ensure ... adequate training of resources to enable quality of deliverables. Manage quality , efficiency, and...Pharmacovigilance Procedures (GVP) required4 or More Years Knowledge of FDA regulations, clinical and safety databases; preferred4 or More… more
- Repligen (Waltham, MA)
- …is based in Waltham, MA, and will report to the Senior Manager of Supplier Quality .Responsibilities Supplier Performance Monitoring and ReportingCollect, ... OverviewWe are seeking a Supplier Quality Engineer to join our growing Supplier ...systems or digital audit tools Familiarity with regulatory standards ( FDA , GMP, etc.). Excellent communication, negotiation, and interpersonal skills.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager , and Manager .Oversee the hiring, development, and performance management ... size.Responsible for multiple work centers within the facility to ensure high quality and compliant product supply and oversee production metrics; these metrics will… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …candidate will be commensurate with experience. Relationships Reports to: Manager , Process Support (Downstream) Essential Functions Assist with coordinating ... for new Manufacturing (process equipment & facility-support equipment) and Quality Control facilities as needed as well as the...and validated in a compliant manner in accordance with FDA , EU and NN requirements Actively participate on cross… more
- Tecomet (Woburn, MA)
- **TITLE** : Quality Assurance & Regulatory Affairs Manager **Department:** Quality Assurance / Regulatory Affairs **Classification:** Exempt **Reports To:** ... create, monitor and improve quality systems/programs, reduce quality costs and maintain compliance within FDA ...reduce quality costs and maintain compliance within FDA and ISO regulations. This is accomplished by maintaining… more
- Actalent (Lawndale, CA)
- Job Title: Quality Manager Job Description We are seeking... Manager to lead and maintain our Quality Management System (QMS) in compliance with FDA ... and other regulatory requirements. This role involves managing audits, overseeing quality processes, and collaborating with cross-functional teams to ensure product… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- Description: The Manager , Field Alert & Recall Compliance is responsible for overseeing regulatory activities related to Field Alert Reports (FARs), product recalls, ... and market withdrawals, including investigation management, FDA notification, and effectiveness monitoring. This role leads site-wide and cross-departmental… more
- Glenmark Pharmaceuticals Inc., USA (Allentown, PA)
- Quality Compliance Manager Department: Quality Location: Allentown, PA START YOUR APPLICATION ... (https://apply.hrmdirect.com/resumedirect/ApplyOnline/Apply.aspx?req\_id=3446854&source=3446854-CJB-0) About the Job The Quality Compliance Manager is responsible for overall… 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: Ensure… 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. ... FDA requirements. + Conduct and participate directly in quality inspections, internal and external audits, and FDA... quality inspections, internal and external audits, and FDA inspections. + Participate in CAPA systems. Prepare reports… more
- Danaher Corporation (Austin, TX)
- …(https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Manager , Clinical Quality and Compliance reporting ... (ie, TMF, SOP compliance, training, etc.), interface to the FDA and notified bodies, clinical CAPA management, and IVDR...Bachelor's degree in science with 14+ years of clinical quality /GCP experience within the device industry OR + Master's… more
- Cambrex High Point (Longmont, CO)
- …compliance with company SOPs, cGMP/cGLP standards and FDA /EU regulations. The Associate Manager of Quality Assurance leads and mentors the quality team ... You Matter by applying today! Job Overview The Associate Manager of Quality Assurance is responsible for...and maintenance of procedures and policies to comply with FDA , EU, and ICH requirements applicable to site's needs.… more
- PCI Pharma Services (Philadelphia, PA)
- …across our global network to pioneer and shape the future of PCI. The ** Quality Systems Manager ** is responsible for overseeing and maintaining the Electronic ... including Deviations, Change Controls and Corrective and Preventative Actions (CAPA). The Manager will also drive initiatives to analyze quality data, identify… more
