Global Regulatory Compliance Auditor

vor 4 Monaten

Zug, Schweiz Kenvue Vollzeit

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.
- Adhere to strict compliance with procedures applicable to my role.
- Exercise the highest level of integrity in the tasks that I perform.
- In a timely and prompt manner, identify, report and seek correction for deviations noted in my workplace.
- Embrace a behavior of employee involvement and commitment to doing the job right the first time. People Managers (If applicable)
- 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.
- 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.
- Plans audits to fit auditee’s site type, products, technology and potential linkages to other sites.
- 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.
- 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.
- 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.
- 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.
- Supports the department effort to maintain the yearly budget.
- 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:

- Proven ability to conduct and manage GxP audits including development of risk-based audit strategies, audit planning, execution, reporting

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