Global Regulatory Compliance Auditor

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 GxP 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.
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