Johnson and Johnson is recruiting for an Enterprise Regulatory Compliance Auditor. This is a fully remote position, with a preference for the incumbent to be based in the United States, however, all applicants in North America and EMEA will be considered.

Johnson & Johnson, through its operating companies, is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the pharmaceutical, and medical devices markets. We strive to provide scientifically sound, high-quality products and services to help heal, cure disease and improve the quality of life.

As part of a team of highly skilled and interactive compliance professionals, the ERC Auditor will help drive improvements in compliance across the Johnson & Johnson Supply Chain while developing their own auditing skills related to new and evolving regulatory requirements around the globe.

• Prepare and conduct Johnson & Johnson Regulatory Compliance (JJRC) Enterprise Regulatory Compliance (ERC) announced and unannounced audits.
• Performs audits of sites for compliance to applicable government regulations, material specifications, international standards and to company policies and procedures.
• As a lead auditor, leading a team of auditors, technical experts, auditors-in-training and/or volunteer auditors provides direction and guidance to audit team. As a team auditor, works under the direction of a lead auditor and in collaboration with the audit team.
• Connect with and coordinate audits with assigned sites across the Enterprise and with J&J External Manufacturers and Suppliers as needed.
• Identify and communicate compliance status and common issues/trends via an independent audit assessment process, including appropriate rating of audits if applicable.
• Document the audit report including all assessment/audit findings accurately and timely in the applicable audit tracking systems.
• Share compliance knowledge and best practices with peers and colleagues to enhance compliance skills and understanding.
• Operate cross-functionally within the J&J Supply Chain sites and operations when conducting audits and reporting outcomes to senior J&J leadership.
• Assures that the site quality system audit function follows QSR/GMP, ISO and other regulatory requirements.
• As required, verifies the effectiveness of supplier corrective action during audit execution.
• As required, assists in formulating supplier procedures to be followed by the auditing group.
• Perform other JJRC activities and supports base business projects and initiatives, as required, to help drive continuous improvements for the organization.
• Maintains abreast of regulatory changes through various means (i.e., industry publications, seminars, participation in organizations, government meetings).
• Follows all company guidelines related to Travel and Expenses, Health, Safety and Environmental practices.

• A degree (BS/BA) in science, engineering, regulatory compliance, or related field is required.
• Minimum of 10 years of related regulated Pharmaceutical, Medical Device and/or OTC Drug industry experience; or MS with 4 or more years of experience; or Ph.D. with 2 or more years of experience. Also, a minimum of 5 years of experience conducting and leading regulatory assessments in a regulated healthcare environment is required. Or equivalent combination of education and experience.

• Minimum of 5 years of experience in a Design Control, Design Quality Engineering and Risk Management role.
• Solid understanding and skills in quality-related methods and techniques including auditing principles and techniques, quality terminology, quality management principles, quality management tools, and their applications.
• Strong functional knowledge of/and experience in quality and compliance of a regulated GxP/QMS environment.
• Strong understanding of Pharmaceutical and/or Medical Device worldwide regulations and standards (i.e., FDA CFR Part 820, Parts 210, 210, Part 11, EU MDR 2017/745, EudraLex Vol. 3 and Vol. 4, ANVISA RDC, Japan MHLW, ISO 130485, ISO 14971).
• Knowledge dealing with worldwide Health Authorities inspections.
• Consistent track record driving progress and remaining focused under ambiguous and complex situations, and ability to assess the vital points of the audit and make big picture decisions and observations.
• Detailed knowledge of how to apply requirements for compliant drug/device/biologic manufacture, including facilities, equipment, documentation, testing, and product flow.
• Strong interpersonal and technical skills to facilitate collaborations between Johnson & Johnson companies.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Strong consultant and leadership skills, while still being a great teammate and working well with others.
• Proven track record to conduct and complete job requirements and priorities independently.
• Ability to read, analyze and interpret scientific and technical journals, financial reports, and legal documents.
• Excellent written and verbal communication, influencing, and negotiation skills to encourage trust and quickly build credibility within the Quality and Compliance community to enable the creative achievement of mutual goals.
• Statistical skills and manufacturing process understanding.
• Ability to stand firm while being open to innovative approaches. Engages in constructive discussions.
• Ability to build partnerships both internally and externally. Ability to effectively communicate with governmental and independent auditors.
• Ability to use a computer and associated Microsoft software, as well as other computer-based systems and applications as needed.

• Computer Systems Validation experience preferred.
• Facility, equipment, process validation principles and applications.
• Understanding of how regulatory bodies approach inspections.
• Knowledge of regulatory and development process (both pre-approval and post launch monitoring) and scale up.
• Six Sigma, Lean, ISO lead auditor, ASQ CQA/CMDA or other recognized auditor certification preferred.

• Language requirements - Full Professional English proficiency or above is required. Additional languages proficiency is a plus.
• Travel percentage - This role requires up to 60% global travel (domestic and international) with higher peaks depending on business needs.

• Vacation - up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year
• Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year