Description
Global Regulatory Compliance Auditor
Responsible for:

• Executing the corporate’s Regulatory Compliance audit program by, among other duties assigned as deemed applicable, performing, and leading, audits across Internal Manufacturing (IM), External Manufacturing (EM), suppliers and others to assure audit readiness and compliance with applicable government regulations, company standards, policies, quality agreements, international standards and procedures.

• Managing the execution of audit planning, scheduling, site coordination, budget, and employee development.
• Identifying, accurately capturing holistic view of potential compliance risks, documenting audit findings and promptly communicating, and as appropriate escalating issues to senior management.

• Issuing and distributing, in a timely manner, audit results for review by management and

• Developing and maintaining effective and collaborative business relationship with key stakeholders and functional department within J&J to ensure that the strategic objectives of the corporate audit program are achieved and continuously improving execution and results based on process insights.

• Maintaining current on regulatory requirements changes and responsible for providing recommendations for audit program improvements to effectively assess Gx P compliance.

• Supporting the Enterprise Regulatory Outreach group to appropriately influence and interpret requirements of the Regulatory Agencies around the globe.

Responsibilities: (Define key accountabilities and/or activities.) Under limited supervision and in accordance with all applicable federal, state and local laws/regulations, the Companies’ policies, procedures and guidelines, this position:
• Ensure quality and compliance in all my actions by: All employees to Attend GMP training on the schedule designated for my role and as appropriate for my role.
o Adhere to strict compliance with procedures applicable to my role.
o Exercise the highest level of integrity in the tasks that I perform.
o In a timely and prompt manner, identify, report and seek correction for deviations noted in my workplace.
o Embrace a behavior of employee involvement and commitment to doing the job right the first time. People Managers (If applicable)
o Ensure employees under your scope of responsibility are trained in required procedures for the execution of their role and maintain current with training requirements during the year. o Promote an environment of employee involvement in the workplace.
o Seek prompt identification, reporting and correction of deviations in the workplace as noted by employees.

• Regulatory Compliance Focus o Provides support to the year’s audit schedule including pre-audit planning, resourcing, scheduling and execution of audits (in-person, remote or using appropriate auditing tools) to ensure the audit program is consistently meeting the objectives of achieving a healthy state of audit readiness.

o Plans audits to fit auditee’s site type, products, technology and potential linkages to other sites.
o Leads and executes audits per said schedule or at the discretion of management based on risk or prioritization deemed necessary and reports via verbal and written communication any outcomes that are in the scope of the audit.
o Immediately escalates significant compliance issues to management capturing description of potential violation, severity and potential impact on the company’s products, systems, processes or consumers.
o Continuously improves technical and interpersonal skills, through training or otherwise, to serve as subject matter expert on Regulatory Compliance matters and help stakeholders improve awareness of potential gaps and opportunities for remediation.
o While in audit, represents the audit team as an engaged partner fostering trust and collaboration to identify strengths and weaknesses, helping the auditee understand their state of compliance and allowing the process to provide the appropriate steps to remediate.
o Support the preparation of metrics and performance data as appropriate, based to support identification of emerging compliance trends. This will enable providing holistic view of potential compliance risks across the company and help deploy countermeasures strategies to prevent impact and sustain state of compliance.
o Supports the department effort to maintain the yearly budget.
o Continuously evaluates Regulatory Compliance procedures identifying improvements based on input from the changing Regulatory requirements, emerging trends, voice of customer and audit outcomes, changes to product, technology portfolios of the company, etc.

Qualifications
Requirements:
Education:
A minimum of bachelor’s degree in science, engineering, or another related field Experience: Experience in conducting or exposure to Quality or Regulatory Compliance auditing in a global regulated healthcare environment. Experience in Quality and Regulatory Compliance. Minimum years of experience is set by department head. Physical Demands: N/A Knowledge, Skills and Abilities:
o Proven ability to conduct and manage Gx P audits including development of risk-based audit strategies, audit planning, execution, reporting audit findings in a concise manner.
o Strong Quality and Compliance background with deep understanding of Global Regulatory c GMP requirements. o Working knowledge of FDA/ European guidance documents.
o Knowledge dealing with Worldwide Health Authorities inspections and their approaches and how to effectively respond to their observations.
o Computer System Validation experience.
o Strong communication skills and ability to quickly build credibility with Operations, Quality and Compliance stakeholders.
o Excellent decision making and analysis skills.
o Exceptional written and oral communication skills with individuals and groups at all levels of the company. o Strong negotiating and influencing skills.
o Ability to identify and take in the vital points of the audit and make big picture decisions and author appropriate observations. o Knowledge of regulatory and development process (both pre-approval and post launch monitoring) and scale up.
Strong understanding of all requirements for compliant drug/ device/ cosmetic/ dietary supplement manufacturing, including facilities, equipment, documentation, testing, and product flow.
o Knowledge in quality-related methods and techniques including auditing principles and techniques, quality terminology, quality management principles/tolls and their application.
Other Requirements: May require up to 40% domestic and international travel.

Primary Location Europe/Middle East/Africa-Switzerland-Zug-Zug

Job Function Regulatory Compliance