Regulatory Inspection Readiness Lead
RXinsider LTD.
Moderna, based in Cambridge, MA, seeks a Regulatory Inspection Lead to plan and coordinate regulatory authority inspections (FDA, EMA) across R&D. You will build stakeholder relationships, prepare for inspections, respond to observations, and track CAPAs to closure, contributing to an inspection-ready culture. You will lead trainings, mock inspections, and development of inspection plans, while partnering with cross-functional teams to ensure compliance and timely regulatory responses in a #J-18808-Ljbffr RXinsider LTD.
- Moderna is seeking a Regulatory Authority inspections expert to plan and coordinate regulatory inspections... .../EMA and ICH GxP standards. You will lead pre-, in-, and post-inspection activities... ...study teams to maintain inspection readiness. Travel up to 30% is required; you...Regulatory
$136.4k - $253.2k
...Analytical Data Science is recognized as a leading hub for top industry talent, operating as an agile workforce to deliver regulatory commitments across the portfolio. We... ...the TA leadYou ensure compliance and inspection readiness by establishing robust quality review processes...RegulatoryFull timeLocal area$144.5k - $195.5k
The Global Study Lead (Sr. Manager, Clinical Operations) is responsible... ...conduct of, Health Authority Inspections and internal QA auditsEnsure... ...constant state of inspection-readiness, collaborating with R&D... ...Research, Commercial, Regulatory, Bio Analytical, Medical Affairs...RegulatoryFull timeTemporary workLocal areaRemote workFlexible hours- ...ensures GxP documents and personnel training records meet regulatory requirements. You will administer the Veeva Vault system,... ...maintain training curricula, track QMS metrics, and support readiness for inspections as Kymera advances late-stage development and #J-18808-...Regulatory
- ...is seeking a dynamic Senior Director of GMP Inspection Management to lead the development of a global inspection readiness program. The role ensures proactive, risk-based... ...and a proven track record with global regulatory inspections, capable of influencing across functions...Regulatory
$195k - $275k
Kymera Therapeutics is seeking an experienced professional to lead TMF management and drive compliance within clinical... ...industry and a robust track record in TMF management, ensuring readiness for regulatory inspections. The role demands strong leadership, experience in...Regulatory- ...Director, CMC Quality Compliance and Inspection Readiness, is responsible for inspection readiness... ...and Skills:Knowledge of regulatory requirements and inspection expectations... ...as six sigma or leanProven ability to lead improvement projects and project teams...RegulatoryFull timeSummer workRemote workFlexible hours2 days per week
- ...an Associate Director, Global Quality to oversee global quality compliance across R&D. This role involves leading compliance projects, ensuring inspection readiness, and embedding quality processes. Candidates should have a strong background in project management and...Regulatory
- .../Associate Director, Quality Management Systems (QMS) to lead the global QMS scope, including document control, records... ...requires strategic vision and operational execution to ensure inspection readiness and regulatory alignment. The ideal candidate will be based in the...RegulatoryWork at office
- ...Operations, this role oversees SOPs, TMF standards, and issue management to ensure programs are inspection ready and compliant with GCP, ICH, FDA, and EMA. You will partner across Regulatory, Quality, Data Sciences, Clinical Research and Pharmacovigilance, drive training,...Regulatory
$128k - $192k
...approved timelines, budget, regulatory requirements, and internal standards... ...processesEnsure site readiness for initiation, including training... ...in audits, inspections, and quality assurance activities... ...skillsLeadership skills with the ability to lead cross-functional teamsStrong...Regulatory$178.1k - $244.86k
...ensuring alignment with enterprise priorities, regulatory requirements, and product lifecycle... ...access globallyACCOUNTABILITIES Lead end-to-end strategy development and execution... ...and SOPs, including supporting audit and inspection readinessMonitor and manage program budgets...RegulatoryMinimum wageTemporary workLocal areaNight shift- ...Associate Director of Quality Systems to lead the QMS, ensure GxP compliance, and... ...processes. The role interfaces with CMC, Regulatory, Clinical Operations, and IT to mature... ...while fostering a culture of inspection readiness. Hybrid work with relocation to Waltham...RegulatoryRelocation
$148.5k - $214.5k
...Framingham, MA About the job Are you ready to shape the future of medicine?... ...roles and responsibilities in leading the preparation of CMC dossiers for regulatory submissions to enable... ...consultation meetings with agency, site inspections, or written responses to Agency’...Regulatory$95k - $130k
...seeking an experienced, hands-on Quality Lead to lead and own the company's Quality... ...driving continuous improvement, regulatory readiness, and a culture of quality across the organization... ...primary on-site liaison during FDA inspections in coordination with global regulatory...RegulatoryFull timePart timeWork experience placementWork at office$110k - $150k
...a part of the process that leads to new cures. WORKING AT... ...associated data workflows meet regulatory expectations for data... ...The role supports audits and inspections, authors technical documentation... ...laboratory technologies to ensure readiness for GMP use. Maintain and...RegulatoryLive inVisa sponsorship- ...is seeking an Associate Director of Quality Systems to lead the QMS, drive regulatory readiness, and partner with IT for system improvements. The role... ...GMP knowledge, and a track record in audits and inspections. The role is hybrid in Bedford, MA, with a move to Waltham...Regulatory
- Initial Therapeutics, Inc. in Cambridge, Massachusetts is looking for a Regulatory Affairs Specialist focused on planning and supporting regulatory inspections. The role involves ensuring compliance with Health Authority Regulations through various activities such as planning...Regulatory
$34.28 - $47 per hour
...Lead Facilities Maintenance TechnicianJoining us is a chance to... ...direct impact on product quality, regulatory compliance, and patient... ...safety regulationsConduct safety inspections and enforce safe work... ...audits and ensure regulatory readiness (e.g., fire systems, emergency...RegulatoryTemporary workFor contractorsLocal areaShift workWeekend work$31.25 - $38 per hour
...compliance with internal and regulatory requirements. Schedule This... ...safety regulations. Receive, inspect, and distribute Quality Control... ..., and maintain audit-ready conditions at all times. Serve... ...train junior staff; partner with Leads and management to support development...RegulatoryHourly payFor contractorsWeekend work- # Lead## Job Description**What You’ll Do**The Shift Lead oversees... ...inventory, and production readiness. • Communicates schedule changes... ...OSHA, and other applicable regulatory and quality system... ...supporting internal audits, inspections, or quality system assessments...RegulatoryFull timeWork at officeImmediate startAll shiftsFlexible hoursShift work
$31.2 per hour
...division of Thermo Fisher Scientific, as a Lead Site Specialist to contribute to global... ...ensuring exceptional customer service and regulatory compliance. You'll implement improvement... ...counts using barcode scanners. ~ Receive, inspect, label, and store incoming chemical...RegulatoryHourly payFull timeTemporary workWork at officeMonday to FridayDay shift- What You’ll Do The Shift Lead Aseptic Manufacturing leads day-to-day aseptic manufacturing... .... Monitor floor inventory, material readiness, and material consumption activities... ...supporting internal audits, quality inspections, and regulatory readiness activities. Experience...RegulatoryWork at officeImmediate startFlexible hoursShift workDay shift
$151.2k - $226.8k
...QMS records are complete, traceable, audit-ready, and meet data integrity... ...time, overdue items, training compliance)Lead QMS simplification/optimization, including... ...environmentsExperience supporting QMS-related inspections and audits QMS design, lifecycle management...- ...ID31748653Reference26-00094 Responsibilities: The Regulatory Coordinator is responsible for the coordination, preparation... ..., OHRP) and guidelines (ICH, GCP). Maintain site readiness for internal and external audits and inspections, including preparing regulatory files and ensuring...RegulatoryWork at officeLocal area
- ...customer trials, and training. Conduct pre-departure inspections and ensure vessels are ready for operation. Monitor vessel systems, propulsion,... ...storage of vessels and equipment. Coordinate with regulatory agencies, marinas, ports, and support vessels when required...RegulatoryFull timeWork at officeRemote workFlexible hours
$200k
...ineligible to apply. Responsibilities The Lead Clinical Laboratory Scientist position... ...dating record sheets. Knowledgeable about inspection requirements, location and existence of... ...results in line with current laboratory regulatory requirements. The work performed may be...RegulatoryPermanent employmentFull timeWork experience placementSeasonal workWork at officeRemote workTrial periodRelocation packageMonday to FridayFlexible hoursWeekend work- ...Wells Fargo is seeking a Vice President, Lead Commercial Real Estate Portfolio Manager... ...review of third‑party reports, inspections, market conditions, and site visits to identify... ...must also meet and comply with ongoing regulatory obligations, which include periodic screening...RegulatoryFull timeWork experience placementWork at office
- ...Seeking a Lead Medical Technologist (blood bank) / Clinical Laboratory Technologist... ...specialty bench testing, ensuring quality and regulatory compliance, accurate performance of all... ...processes as may be required during an inspection. May be required to tabulate and report...RegulatoryFull timeBank staff
$178.5k - $257.83k
...jobAs the Biomarker and Precision Medicine Lead, you’ll be developing and implementing... ...robust pipeline in Immunology & Inflammation. Ready to get started?Join the engine of Sanofi’... ...project documentation and regulatory complianceCollaboration & Communication:Work...RegulatoryFull timeWork at office
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