Manager, Source Regulatory Compliance (APAC)

About Johnson & Johnson MedTech

Johnson & Johnson is dedicated to advancing healthcare innovation globally with a vision to prevent, treat, and cure complex diseases. Leveraging expertise in innovative medicine and medical technology, the company strives to deliver smarter, less invasive, and personalized healthcare solutions that make a significant impact on global health.

Operating under the values of Our Credo, Johnson & Johnson fosters an inclusive and respectful workplace, valuing diversity and the individuality of all employees worldwide.

Position Summary

The role of Manager, Source Regulatory Compliance for the Asia-Pacific (APAC) region involves leading compliance efforts concerning suppliers, sourcing, and external processes. The position ensures that suppliers, contract manufacturers, and sourced materials meet relevant regulatory mandates, industry quality standards, and internal corporate policies. This leadership role is crucial for protecting product quality, preparing for audits, and ensuring compliant and uninterrupted supply chain operations across varied APAC markets through close collaboration with Quality, Regulatory Affairs, Supply Chain, and Procurement departments.

Core Responsibilities

• Oversee and direct regulatory compliance activities for sourcing operations across APAC, ensuring strict adherence to applicable regulations and quality system standards.
• Maintain regulatory compliance oversight of suppliers, contract manufacturers, and externally provided services and processes.
• Collaborate with Supply Chain, Procurement, Quality, and Regulatory Affairs teams to facilitate compliant supplier qualification, continuous monitoring, and management throughout the supplier lifecycle.
• Analyze regional and country-specific regulatory obligations, translating these into precise sourcing and supplier compliance requirements.
• Support and participate in internal and external audits, as well as health authority inspections concerning sourcing and supplier regulatory compliance.
• Track compliance risks and trends, assess supplier performance metrics, and initiate corrective and preventive actions as needed.
• Ensure consistent enforcement and application of global and regional compliance policies, procedures, and controls throughout the APAC region.
• Lead initiatives for continuous improvement to enhance the governance and effectiveness of sourcing compliance activities.

Candidate Qualifications

• Bachelor’s degree in Regulatory Affairs, Quality, Engineering, Life Sciences, Supply Chain, or a related field is mandatory.
• Advanced degrees in scientific, regulatory, or business disciplines are advantageous.
• Extensive experience (generally between 6 to 8 years) in regulatory compliance, quality assurance, supply chain management, or related positions within regulated industries.
• Comprehensive understanding of regulatory and quality requirements related to sourcing and supplier operations.
• Proven experience providing support during supplier audits, inspections, and compliance evaluations.
• Capability to manage complex compliance issues spanning multiple countries and diverse stakeholder groups.
• Strong analytical thinking, risk assessment, and problem-solving competencies.
• Excellent verbal and written communication skills.
• Preferred experience includes backgrounds in medical devices, healthcare, or regulated sectors.
• Familiarity with APAC regulatory bodies and frameworks for supplier compliance is beneficial.
• Prior experience working in multinational or matrix organizations is a plus.
• Knowledge of regulatory inspections focusing on supplier or contract manufacturing oversight.
• Relevant certifications such as RAC or ASQ are preferred but not mandatory.

Additional Information

• Language proficiency in English is required; knowledge of Mandarin or other APAC languages is favorable.
• The position requires moderate travel within the APAC region.
• Johnson & Johnson is undergoing a transition process to establish DePuy Synthes as a standalone orthopaedics company, anticipated within 18 to 24 months subject to regulatory and legal approvals. Future employment for this role may be under DePuy Synthes with corresponding policies and benefits.
• The company embraces equal opportunity employment practices and is committed to accommodating applicants with disabilities throughout the recruitment process.