Regulatory Affairs: Process Excellence & CAPA Lead
K3-Innovations, Inc.
K3-Innovations is seeking an experienced Regulatory Affairs Associate III to support Process Excellence and Issue Management activities within Regulatory Affairs. The role focuses on keeping operations compliant, efficient, and inspection-ready while coordinating with cross-functional stakeholders to manage issues, CAPAs, and legacy integrations. The ideal candidate has 5+ years of regulatory/pharma/medical device experience, strong process-excellence capabilities, and a proven ability to drive #J-18808-Ljbffr K3-Innovations, Inc.
- Orion Group in North Chicago, IL is hiring a Regulatory Affairs Associate III focused on process excellence, CAPA management, and inspection readiness. You will oversee the RAIM system, triage issues, and partner with cross-functional teams to drive improvements. You will...Process Excellence
$60 - $63 per hour
Regulatory Affairs Associate III - Regulatory Process Excellence, CAPA Management & Inspection Readiness Location: Hybrid - North Chicago, IL (onsite Tuesday, Wednesday, and Thursday) Length of Assignment: Through June 2027 Pay Rate: $60-63/hr (depending on candidate medical...Process Excellence- Job-ID32908843Reference26-01550 Summary: The Manager, Process Excellence within Regulatory Affairs is responsible for managing key process excellence and issue... .... This role oversees the Regulatory Affairs Issue and CAPA Management system (RAIM), triages issue records,...Process Excellence
- Abbott Laboratories in IL is seeking a Sr IT Compliance Analyst - CAPA to establish and maintain productive relationships across BTS and divisional IT. You will lead CAPA investigations, coordinate cross-functional teams, and ensure timely remediation of CAPA events. The...Suggested
- Abbott Laboratories in IL is seeking a Sr IT Compliance Analyst - CAPA to lead IT CAPA events and drive corrective actions within a... ...experience, strong analytical and stakeholder skills, and familiarity with AI-enabled processes. #J-18808-Ljbffr Abbott LaboratoriesSuggested
- The Fountain Group is seeking a Manager, Process Excellence to support compliant, efficient Regulatory Affairs operations. You will manage issue/CAPA workflows, drive cross-functional process improvements, and ensure inspection readiness across teams. You will triage severity...Process Excellence
- Creative Solutions Services, LLC is seeking a Manager, Process Excellence within Regulatory Affairs to oversee issue and CAPA management programs and drive cross-functional process improvements. The role supports inspection readiness, audit responses, and change management...Process Excellence
- ...K3-Innovations is seeking an experienced Regulatory Affairs Associate III to support Process Excellence and Issue Management activities within Regulatory Affairs.... ...with cross-functional stakeholders to manage issues, CAPAs, Exception Reports, process improvements, audits/...Process Excellence
- ...Title: Process Excellence Manager- Regulatory Affairs Location: North Chicago, IL | Onsite Duration: 10+ Months (Potential Extension)... ...This role oversees the Regulatory Affairs Issue and CAPA Management system (RAIM), triages issue records, escalates...Process Excellence
$65 - $70 per hour
...years of experience within Regulatory Affairs, pharmaceutical, biotechnology... ...with issue management, CAPA, deviations, investigations,... ...) and controlled compliance processes. Experience supporting internal... ...company integrations, process excellence, or continuous improvement ....Process Excellence- Baxter International Inc. is seeking a Quality Associate II to support complex QMS processes, change control, CAPA, and inspections across our manufacturing and quality systems. You will lead routine investigations, analyze data, and coach peers while ensuring safety and...
- AbbVie in North Chicago, IL seeks a Strategic Change Enablement (SCE) Manager I to lead process improvement initiatives within the Compliance Learning Change Management organization. You will partner across CLCM to plan, deliver improvements, and align quality systems...Process Excellence
- AbbVie is seeking a Strategic Change Enablement (SCE) Manager I to partner across the CLCM organization, planning and delivering process improvement initiatives that support clinical research processes. You will drive development of clinical research processes, including...Process Excellence
- A global staff augmentation firm is seeking a Senior Regulatory Affairs professional to oversee drug product development and compliance. This role requires a minimum of 5 years of experience in drug development, including direct management of new drug approvals. Responsibilities...
- ICU Medical is seeking an experienced Regulatory Affairs professional to support global and US registrations for device products. You will analyze... ...have 7+ years in medical products, strong ability to lead regulatory arguments, and experience coordinating with RAs across...
- AbbVie seeks a Senior Manager Regulatory Affairs to lead US & Canada regulatory strategy. The role involves shaping regulatory plans, interfacing with FDA, coordinating submissions, and guiding cross-functional teams to ensure compliant commercialization. The position...
Regulatory Affairs, Global Reg Strategy US & Canada (Hybrid). You will develop and execute regulatory strategy and tactics for US/Canada, coordinating with FDA to ensure timely filings and inspections and enabling...
- AbbVie is seeking a Senior Manager, Regulatory Affairs US & Canada Strategy Lead - Aesthetics Device to develop and execute regulatory strategies for on-market and development products in the US and Canada. You will coordinate lifecycle activities, interface with Health...
- Jobtailor in Lake Forest, IL is seeking an experienced Regulatory Affairs professional to support medical device programs. You will provide regulatory... ...with regulatory bodies to ensure compliance. You will lead regulatory positions at development meetings, evaluate...
- Goodwill Industries of Southeastern Wisconsin, Inc. is seeking a Director of Quality and Process Improvement in Great Lakes, Illinois. This role involves overseeing all quality assurance, process improvement, and operational training initiatives across the organization,...Process Excellence
$66 - $72 per hour
...Job Description Job Title: Regulatory Affairs Associate I Job... ...plays a key role in driving process excellence and issue management within... ...Regulatory Affairs Issue and CAPA Management system, supports... ...Facilitation skills to lead discussions, drive alignment...Process ExcellenceContract workTemporary workWork at officeRemote work- AbbVie is seeking a Manager, Regulatory Affairs Submission Management to lead high‑impact submission projects, coordinating cross‑functional teams to deliver... ...drive content planning, vendor interactions, and process improvements while mentoring junior staff and maintaining...
- ..., X and YouTube. Job Description The Senior Manager, Regulatory Affairs US & Canada Strategy Lead - Aesthetics Device is responsible for the development... ...is a plus. Other Required Skills Demonstrates excellent negotiation skills, problem solving skills and builds...Local area
$149.3k - $298.7k
...spans the spectrum of healthcare, with leading businesses and products in diagnostics,... ...medical plan in the next calendar year.An excellent retirement savings plan with a high employer... ...and adoption of the capabilities and processes required to deliver a digital solution...Process ExcellenceWorldwide- ...Planning to translate IT objectives into actionable roadmaps and lead change initiatives. The ideal candidate will have a Bachelor's degree and 5+ years of experience in IT strategy or process excellence. Responsibilities include developing executive scorecards, overseeing...Process Excellence
- ...information about AbbVie, please visit us at Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube. Job Description A sustainable process development and continuous improvement strategy is crucial to Quality Management System in GCP governing R&D. The Compliance...Process Excellence
- ...information about AbbVie, please visit us at Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description A sustainable process development and continuous improvement strategy is crucial to Quality Management System in GCP governing R&D. The Compliance...Process ExcellenceLocal area
- ...functional R&D organization that includes CMC (Process R&D, Drug Product Development and... ...: The Associate Director, Strategy Lead for Submission Automation is responsible... ...management, Development Sciences, Regulatory Affairs, and IT to understand current-state reporting...Full timeLocal area
- ...AbbVie seeks a Regulatory Strategy Lead for US and Canada to shape lifecycle planning, manage health authority interactions, and coordinate submissions across a complex, matrixed organization. You will collaborate with diverse teams to ensure compliant, timely regulatory...
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