Johnson & Johnson Loopbaan
Lead Auditor – External Manufacturer’s and Supplier Audit
Requisition ID: 1805641211W
Assures that the supplier or EM quality system audit function complies with QSR/GMP, ISO and other regulatory requirements.
Performs audits of suppliers or EMs for compliance to applicable government regulations, material specifications, to international standards and to company policies and procedures.
Ensures audit reports are issued within the prescribed time frame.
Performs supplier or EM re‑audits of deficient matters and corrective actions, as needed and required.
Assigns classifications and documents supplier or EM audit results in written audit reports that are distributed and reviewed by appropriate management.
Monitors the effectiveness of supplier or EM corrective action responses.
Can serve as lead auditor, leading a team of auditors, technical experts, auditors-in-training and/or volunteer auditors.
Maintains files containing reports of supplier or EM audits, re‑audits and corrective action responses.
Provides direction and guidance to auditors in training and/or volunteer auditors.
Collects and reviews supplier or EM audit metrics and communicates to site and worldwide management. Generates data for management reviews.
Assists in formulating supplier or EM procedures to be followed by the auditing group.
Maintains abreast of regulatory changes through industry publications, seminars, participation in trade organizations, and government meetings.
Responsible for following all company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.
Serve as compliance partner and key advisor related to GxP processes in the areas of software development, across a broad portfolio covering GxP applications, Software as a Medical Device (SaMD), Mobile Medical Apps (MMaps), and other Health software digital products, as applicable.
Partner with stakeholders to assess, develop and implement solutions that enable compliant innovation. Identifies potential risks, articulates impact, and works with business partners to establish proactive risk mitigation strategies. Creates compliance strategies, including authoring position papers, to enable innovation in emerging areas, as applicable.
Providing tactical GxP compliance support to base business and innovation initiatives, including healthcare technology and digital health related projects to ensure inspection readiness and effectiveness of remediation action plans, as applicable.
Education and/or Experience: BS in a related science or engineering field of study; and 8 or more years of related experience and/or training; or MS with 6 or more years; or Ph.D. with 4 or more years; or equivalent combination of education and experience. Proven ability to conduct and manage audits required. Computer Systems Validation experience preferred. Knowledge dealing with the Food & Drug Administration. Knowledge and skills in quality-related methods and techniques including auditing principles and techniques, quality terminology, quality management principles and their applications and quality management tools and their applications.
Other Skills and Abilities: Good written and oral English communication skills. Ability to read, analyze and interpret scientific and technical journals, financial reports, and legal documents. Experience in Quality System regulations, ISO, ICH, PIC/S, and cGMP regulations, including Annex 11, 21 CFR Part 11, Part 210, Part 211 and Part 820 is required and how these apply to Computer Systems and software medical devices is preferred. Expertise in medical device quality, including standards for medical device software development and risk management (e.g., ISO, IEC, AAMI) is preferred. Experienced knowledge of IT internal controls, SDLC methodologies, GAMP5 and data integrity requirements is preferred. Ability to select, manage and direct a team during an audit. Ability to respond to common inquiries, regulatory agencies, or members of the business community. Strong statistical skills and manufacturing process understanding. Ability to lead a team through a root cause analysis problem. Ability to effectively present information to top management, public groups, and/or boards of directors. Engages in constructive conflict. High tolerance for ambiguity in a complex environment. Makes the complex clear and easily understood by others. Ability to stand firm while being open to new approaches. Ability to build partnerships both internally and externally. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Ability to use PC's and associated Microsoft software. Ability to effectively interface with governmental and independent auditors. Six Sigma, Lean, ISO lead auditor, or ASQ CQA certification and trainings are preferred.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit and stand for long periods of time. Specific vision abilities required by this job include close vision. While performing the duties of this job, the employee occasionally works near moving mechanical parts and is occasionally exposed to fumes or airborne particles and risk of electrical shock.
The position will require approximately 60% travel both domestically and internationally.
Europa/Midden-Oosten/Afrika-Nederland-Noord Holland-Amsterdam, Europa/Midden-Oosten/Afrika-Nederland-Zuid Holland-Leiden, Europa/Midden-Oosten/Afrika-Nederland-Utrecht-Amersfoort, Europa/Midden-Oosten/Afrika-Nederland-Utrecht-Utrecht
AMO Groningen BV (8358)