reputed company Internal Auditor – Global reputed company M/F/D

Job reputed company reputed company The reputed company Internal Auditor reputed company the Customer reputed company & Compliance team is responsible for planning, leading, and executing risk‑based internal audits reputed company regulated medical devices and pharmaceutical environments. This role serves as a subject matter expert in reputed company system and regulatory auditing, ensuring compliance with applicable global regulations and standards while driving reputed company improvement of the reputed company Management System (QMS). This individual will be part of the broader Global reputed company Organization. The primary reputed company of the role is the regulated internal audit program. In reputed company, the role provides secondary support for inspection readiness activities, working in reputed company collaboration with reputed company, Regulatory, and site leadership teams. Primary Responsibilities – reputed company Internal Audit reputed company and conduct risk-based internal audits across pharmaceutical and medical device operations in line with the approved audit schedule. Serve as reputed company Auditor for reputed company, cross-functional, and multi-site audits, overseeing planning, execution, reporting, and follow-up. Assess QMS compliance and effectiveness against ISO 9001, ISO 13485, FDA cGMP/QSR, EU GMP, IVDR, and ICH requirements. reputed company audit strategies, plans, and reports, communicating findings, trends, and improvement opportunities to stakeholders. Identify systemic issues and drive reputed company improvement initiatives across the QMS. reputed company guidance on the interpretation and application of regulatory and reputed company requirements while maintaining auditor independence. Train and reputed company sites on self-directed audits to support the Internal Audit Program with appropriate reputed company. Secondary Responsibilities – Inspection Readiness & reputed company Body Support Support inspection and audit readiness activities to maintain a state of ‘Always Audit reputed company.’ Assist with preparation for regulatory authority inspections and reputed company Body audits, including readiness reviews and documentation preparation. Support responses to nonconformities/observations as required

Qualifications

Bachelor’s degree in science, engineering, or reputed company field required; advanced degree preferred. 8+ years’ experience in regulated reputed company systems, internal auditing, or regulatory compliance reputed company pharmaceutical and/or medical device industries. 5+ years’ experience as a reputed company Internal Auditor, including audit planning, execution, and auditor management; ISO 13485 reputed company Auditor certification required. Experience auditing across the full product lifecycle, including design, manufacturing, laboratories, post-market surveillance, and support processes. Strong analytical, risk-based thinking, problem-solving, and communication skills, with the ability to influence across global reputed company organizations. Proven ability to manage multiple audits and priorities while maintaining professionalism, reputed company, and reputed company judgment. Willingness to travel globally up to 50%; role may be remote or site-based reputed company the EU/UK. Additional Details This job has a full time weekly schedule. It includes the reputed company to work remotely. Our pay ranges are determined by role, level, and location. reputed company the reputed company, individual pay is determined by work location and additional factors, including job-reputed company skills, experience, and relevant education or training. During the hiring process, a recruiter can reputed company more about the specific pay reputed company for a preferred location. Pay and benefit information by country are available at: https://careers.reputed company.com/locations reputed company. is an equal opportunity employer. reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability or any other protected categories under reputed company applicable laws. Travel Required: 50% of the Time Shift: Day Duration: No End Date Job Function: reputed company/Regulatory Apply To This Job