Johnson & Johnson Careers
Lead Supplier Auditor
Requisition ID: 8129180727
Johnson & Johnson Vision is currently recruiting for a Lead Supplier Auditor to be located in Jacksonville, FL.
Johnson & Johnson Vision is committed to improving and restoring sight for patients worldwide. Since debuting the world’s first disposable soft contact lens in 1987, it has been helping patients see better through their world-leading ACUVUE® Brand Contact Lenses. In 2017, J&J expanded into cataract surgery, laser refractive surgery (LASIK) and consumer eye health and now serves more than 60 million patients a day across 103 countries with its eye health portfolio. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
As the Lead Auditor you will perform planned and unplanned Supplier or External Manufacturer (EM) audits to verify compliance to applicable government regulations, standards and to company policies and procedures. Provides supplier or EM compliance expertise to the organization as required.
As the Lead Auditor you will be responsible for the following:
- Assure that the supplier or EM quality system audit function compile with QSR/GMP, ISO and other regulatory requirements.
- Perform audits of suppliers or EMs for compliance to applicable government regulations, material specifications, to international standards and to company policies and procedures.
- Ensure audit reports are issued within the prescribed time frame.
- Perform supplier or EM re audits of deficient matters and corrective actions, as needed and required.
- Assign classifications and documents supplier or EM audit results in written audit reports that are distributed and reviewed by appropriate management.
- Monitor 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.
- Maintain files containing reports of supplier or EM audits, re audits and corrective action responses.
- Provide direction and guidance to auditors in training and/or volunteer auditors.
- Collect and review supplier or EM audit metrics and communicates to site and worldwide management. Generates data for management reviews.
- Assist in formulating supplier or EM procedures to be followed by the auditing group.
- Maintain abreast of regulatory changes through industry publications, seminars, participation in trade organizations, and government meetings.
- 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.
- Provide 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.
- 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).
- Proven ability to conduct and manage audits required.
- Knowledge dealing with the Food & Drug Administration is required
- 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.
- Experience in Quality System regulations, ISO, cGMP regulations, including 21 CFR Part 11, and Part 820.
- 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.
- 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.
- ISO lead auditor, or ASQ CQA certification and trainings.
- The position will require approximately 60% travel both domestically and internationally.
- Computer Systems Validation experience.
- Ability to read, analyze and interpret scientific and technical journals, financial reports, and legal documents.
- Experience in Quality System regulations, ICH, PIC/S, Annex 11, Part 210, Part 211 and how these apply to Computer Systems and software medical devices.
- 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.
- Strong statistical skills and manufacturing process understanding.
- Six Sigma, or Lean certifications.
You should be able to engage 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.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Johnson & Johnson Vision Care, Inc. (6094)