ERC Compliance Auditor in Norderstedt bei Johnson & Johnson

Johnson & Johnson

"Caring for the world… one person at a time” … inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo

Enterprise Regulatory Compliance Auditor

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

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: