- Novo Nordisk Inc. (Plainsboro, NJ)
- …in compliance with local and federal regulations (21 CFR FDA Post-Marketing), global/local SOPs, and other governing standards Maintains proficient understanding ... interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ensuring highest quality to patients. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements in relation to ... applicable Develops comprehensive, relevant resources (eg training program, FAQs) to enable compliance with quality control process requirements across NNI and… 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....chain and customer focus. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements… 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 ... systems auditing program fulfills regulatory requirements performs audits, identifies compliance issues and trends, reviews systems and procedures.Ensure trending… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Manager Audits & Compliance , GCP/Document Audits supports end-to-end audit ... provide inspection management support and follow-up activities post inspection regarding compliance commitments are fulfilled on time and that evidence is… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …more years with focus on pharmaceutical regulatory affairs, incl. familiarity with regulatory compliance frameworks (eg, ICH, FDA , EMA) (Required)2 or more years ... areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global Regulatory Affairs (GRA)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and aggregate reporting for DSI products, both investigational and marketed. Maintains compliance with Global PV regulations for individual case safety and periodic ... in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the management of PV… more
- Repligen (Waltham, MA)
- …growing Supplier Quality team. You will a key role in ensuring the quality , compliance , and performance of Repligen's global supplier base. This is an ... is based in Waltham, MA, and will report to the Senior Manager of Supplier Quality .Responsibilities Supplier Performance Monitoring and ReportingCollect,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …teams, manage performance, and develop talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA , EMA, and ... schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager , and Manager .Oversee the hiring, development, and performance management… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …activities Ensures change control activities for systems are completed in a manner in compliance with FDA , EU and NN regulations Responsible for the verification ... candidate will be commensurate with experience. Relationships Reports to: Manager , Process Support (Downstream) Essential Functions Assist with coordinating… more
- Danaher Corporation (Austin, TX)
- …System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Manager , Clinical Quality and Compliance ... and program including internal GCP auditing (ie, TMF, SOP compliance , training, etc.), interface to the FDA ...Bachelor's degree in science with 14+ years of clinical quality /GCP experience within the device industry OR + Master's… 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… 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
- Integra LifeSciences (Cincinnati, OH)
- …new treatment pathways to advance patient outcomes and set new standards of care. The ** Quality Compliance Manager ** will have a key leadership role ensuring ... of CAPA Review Board (CRB). + Management of site Training Program to ensure compliance . + Quality Management Review coordination and preparation. + Quality … more
- Abbott (Sturgis, MI)
- …Our 114,000 colleagues serve people in more than 160 countries. **Job Title** Project Manager , Quality and Compliance **Working at Abbott** At Abbott, you ... Apply safety, quality , and change management practices; resolve quality issues. + **Regulatory Compliance ** : Ensure adherence to FDA , OSHA, and company… more
- Tecomet (Woburn, MA)
- …and improve quality systems/programs, reduce quality costs and maintain compliance within FDA and ISO regulations. This is accomplished by maintaining ... **TITLE** : Quality Assurance & Regulatory Affairs Manager ...procedures to ensure is in compliance with FDA 21 CFR, Part 820, Quality System… more
- United Therapeutics (Little Rock, AR)
- …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
- Actalent (Lawndale, CA)
- …are seeking an experienced Quality Manager to lead and maintain our Quality Management System (QMS) in compliance with FDA and other regulatory ... Quality Manager Job Description We...Responsibilities + Lead and maintain the company's QMS in compliance with FDA and other regulatory requirements. +… more
Related Job Searches:
Compliance,
Compliance Manager,
FDA,
FDA Manager,
Manager,
Quality,
Quality Compliance,
Quality Compliance Manager