Enterprise Regulatory Compliance Auditor

1 month ago

Cincinnati, Ohio, United States Johnson & Johnson Full time


Johnson & Johnson is currently recruiting for an Enterprise Regulatory Compliance Auditor This position can be performed globally with a preference for the US. Remote work may be considered on a case-by-case basis and if approved by the business.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at

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.

The Enterprise Regulatory Compliance (ERC) Auditor will conduct announced and unannounced audits across all Johnson & Johnson operating units, External Manufacturers, and suppliers of Johnson & Johnson to determine the ability of sectors and sites to meet regulatory compliance requirements. This individual will complete these audits, based on an approved audit schedule. The ERC Auditor will determine and document site inspection readiness, facility operating conditions, and adherence to Johnson & Johnson enterprise standard operating procedures and regulatory requirements by sector and local operating units.

The ERC Auditor will report to the Enterprise Regulatory Compliance Audit - Team Leader and be a part of the ERC Audit Team.

Key Responsibilities:
  • 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.
Qualifications

Education:
  • 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.
Experience and Skills:

Required:
  • 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.
  • Ability to develop risk-based audit plans thorough examination of all relevant evidence and execute audits independently.
  • 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
  • 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, manage basic financial reports associated to the responsibilities of the audit program, 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.]
Preferred:
  • Computer Systems Validation experience preferred.
  • Knowledge of design control, 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.
Other:
  • 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.
  • This position has an estimated annual salary of 99, ,000 USD$
  • Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
    - Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
    - This position is eligible to participate in the Company's long-term incentive program.
    - Employees are eligible for the following time off benefits:
    - Vacation - up to 120 hours per calendar year
    - Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
    - Holiday pay, including Floating Holidays - up to 13 days per calendar year
    - Work, Personal and Family Time - up to 40 hours per calendar year
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit .]

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