Job Description

Johnson & Johnson is currently recruiting a Regulatory Compliance IM Auditor APAC (New Consumer Health Company). This position will be located in Singapore. Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science - bringing innovative ideas, products, and services to advance the health and well-being of people. With $82.1 billion in 2020 sales, Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices markets. 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. If you have the talent and desire to touch the world, Johnson & Johnson has the career opportunities to help make it happen. Thriving on a diverse company culture, celebrating the uniqueness of our employees, and committed to inclusion. Proud to be an equal opportunity employer. Johnson & Johnson is the world's most comprehensive and broadly-based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical and medical devices & diagnostics markets and have the skills and resources to tackle the world's most pressing health issues. Johnson & Johnson announced plans to separate our Consumer Health business to create a new publicly traded company. The process of the planned separation is anticipated to be completed within 24 months, and it will be subject to legal requirements including consultation with works councils and other employee representative bodies, as required, and other customary conditions, and approvals. It is anticipated that, following conclusion of the transaction, this position may be conveyed with New Consumer Health. In that case, details of any planned changes would be provided to the successful candidate by New Consumer Health at an appropriate time and would be subject to any necessary consultation processes.

Role & Responsibilities: The Regulatory Compliance IM Auditor will conduct announced, unannounced and for cause audits across all NCHC operating units and External Manufacturers of NCHC products to determine the ability of audited sites to meet regulatory compliance requirements. This position will plan and execute these audits based on an approved schedule. The Regulatory Compliance IM Auditor will determine and document site inspection readiness, facility operating conditions, and adherence to NCHC standards, as well as standard operating procedures and regulatory requirements. This position will identify and communicate compliance status and common issues/trends via an independent audit assessment report and document all assessment findings and commitments accurately and timely in the official audit record system and verify that those commitments have been completed and effective during future audits. This position requires the ability to influence up as the Regulatory Compliance IM Auditor will routinely interact with Quality Directors and Site Leads, this position needs to effect continuous improvement without having line authority.

Qualifications
Required:

• Bachelor’s degree in science, engineering, or equivalent.
• A minimum of 10 years of experience in conducting Quality or Regulatory Compliance auditing in a global regulated healthcare environment.

• Functional knowledge of/and experience in Quality & Regulatory Compliance.
• Knowledge of Global Regulatory cGMP requirements for drugs, dietary supplements, and/or devices, as well as the regulatory and development process (pre-approval and post-launch monitoring) and scale up.
• Working knowledge/Understanding of computer system validation.
• Knowledge of how Regulatory Bodies/Boards of Health approach inspections, and how to effectively respond to Regulatory Health Authority observations.
• Strong communication skills and the ability to quickly build credibility with Operations, Quality, and Compliance stakeholders.

• Ability to identify and take in the vital points of the audit and make big picture decisions and author appropriate observations.

Preferred:

• Expertise dealing with the Worldwide Health Authorities.
• Knowledge in quality-related methods and techniques including auditing principles and techniques, quality terminology, quality management principles/tools and their application.

• Knowledge of regulatory and development process (both pre-approval and post-launch monitoring) and scale up.
• Working knowledge of FDA Guidance Documents.
• Understanding of all requirements for compliant drug/device/cosmetic/dietary supplement manufacturing, including facilities, equipment, documentation, testing, and product flow.
• Strong personal leadership with demonstrated competency in collaborating with cross-functional and senior leadership.
• Exceptional written, verbal, and presentation communication skills.
  

Primary Location
Singapore-Singapore-Singapore-
Organization
Johnson & Johnson Pte. Ltd. (8435)
Job Function
Quality
Requisition ID
2206064949W