- Novo Nordisk Inc. (Plainsboro, NJ)
- …pharmaceutical or medical device/pharmaceutical combination product experience and actual regulatory experience Advanced knowledge of pertinent FDA regulations ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- JobsRUs (St. Louis, MO)
- …and analysis in case if requestedAssist and advise in activities related to regulatory registrations, listing, and regulatory compliance , with particular ... JobsRUs.com is seeking to hire a Quality & Regulatory Affairs for our...changes to products or sale of products ensuring continual compliance to all applicable regulations and ensuring that site… more
- DivIHN Integration Inc (Green Oaks, IL)
- … regulatory obstacles. Participate in risk benefit analysis for regulatory compliance . Determine and communicate submission and approval requirements. ... for Class III implantable medical devices. May require an advanced degree and 5-8 years of direct experience in...experience in a regulated industry (eg, medical products, nutritionals). Regulatory area is preferred but may consider quality… more
- DivIHN Integration Inc (St. Paul, MN)
- …Specialists Divya at 224 369 2969 Sivanesan at 224 369 0756 Title: Cybersecurity/ Quality systems/ Compliance Analyst Location: St. Paul, MN Or Waukegan, IL/ ... remediation of product cybersecurity tools and systems to ensure compliance with quality system requirements. Partner with...with quality system requirements. Partner with Client Quality and Regulatory and other functions, as… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …major programs or initiatives, and may function in a project leadership role Regulatory compliance : Ensures compliance with all Federal regulations, ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …risk assessments to prioritize investigations based on potential impact on product quality , patient safety, and regulatory compliance . Address recurring ... life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including… more
- Option Care Health (Bannockburn, IL)
- …investigations. * Defining, developing, and implementing strategies to identify and address regulatory and compliance risks and trends. * Ensuring that Option ... risks, including but not limited to Legal, Human Resources, Quality & Risk Management, Finance and Operations. Consults with... compliance trends and best practices in healthcare compliance and the regulatory landscape to proactively… more
- Amerantbank (Miramar, FL)
- This role will manage regulatory compliance audits performed by in house staff or an outsourced firm and the validation work related to issues identified in ... Compliance Risk Assessment, Fair and Responsible Banking, change management and Compliance Quality Assurance) carried out by second line of defense and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including ... of multiple myeloma. Legend Biotech is seeking Operations Manager- Investigations and Compliance as part of the Technical Operations team based in Raritan, NJ.… more
- DivIHN Integration Inc (Round Lake, IL)
- …and coordinates compliance audits and quality systems assessments ensuring compliance with corporate and regulatory provisions of the Quality System. ... audits and compliance gap analysis using the applicable quality manuals, global and/or local procedures, applicable country regulations, directives, standards,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in-built controls in relevant process steps to ensure adherence to regulatory compliance .Monitor effectiveness of implementation of applicable clinical ... Reviews of respective product profile to ensure appropriate management review of all quality and compliance related topics including the review of Key … more
- Insmed Incorporated (Bridgewater, NJ)
- …the Senior Director of Pharmacovigilance QA serves as a strategic partner managing quality and regulatory compliance related to Good Pharmacovigilance ... strategic direction with cross functional working groups to identify and mitigate GVP quality and compliance issues/risks. Provide support and training to other… more
- Beacon Hill Staffing Group, LLC (Chicago, IL)
- …resulting in the need for a comprehensive audit of HR files to ensure regulatory compliance and streamline processes. The ideal candidate will have a proven ... ensure compliance with relevant laws, regulations, and internal policies.Utilize advanced Excel skills to organize and analyze large datasets for reporting and… more
- Insmed Incorporated (Bridgewater, NJ)
- …York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director Quality GMP Compliance , the Director, Quality Operations will ... compliance requirements, work with critical suppliers to ensure quality , consistent supply.Review and monitor all lab processes to...discipline and a minimum of 15 years of relevant Quality Assurance experience; advanced degree and a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …potential new metricsSupporting continuous improvement projects assigned potentially within regulatory compliance , internal/supplier auditing, or customer focus ... areas centered around rare diseases and immune disorders. Job Summary The GMP Quality Assurance Internship is a program that provides training for the intern in… more
- Nesco Resource (Devens, MA)
- …and accuracy of products, processes, and production equipment.Develops and establishes advanced quality systems and procedures, inspection plans, quality ... and Program Management- AS1000- (PPAP) Production Part Approval Process- (APQP) Advanced Product Quality Planning- First article inspection and zero… more
- Jacobs (Scoville, ND)
- … quality interfaces and performance and reporting subcontractor programmatic/process compliance issues/concerns to Jacobs Quality and Construction Management. ... credentials or ability to obtain within one year, or advanced experience participating in and supporting quality ...agent of people to foster a culture of high compliance to quality standards and create, maintain… more
- Option Care Health (Bannockburn, IL)
- …Summary:Under the direction of the Sr. Manager, Clinical Risk Management, the Quality and Risk Data Manager shall have responsibility for managing risks related ... to external inspections or surveys. Manages patient/provider/prescriber complaints ensuring compliance with grievance protocols and response timelines. Supports a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …deliverable quality , and expedite the preparation of oncology compound regulatory submission. It will also to maintain institutional knowledge across oncology ... programming standard on datasets and TFLs to improve efficiency and quality .Responsibilities- By leading internal programming contractor or by self, perform… more
- CJ Logistics America (Litchfield Park, AZ)
- … improvement Ensure alignment and execution of assigned portions of the facility Quality Management System Manage regulatory requirements including set up and ... Position Overview: The Quality Supervisor is responsible for using business intelligence...Conduct mock track and trace events Monitor and ensure compliance with key process outputs, events and dates Perform… more
