Global Source Quality Compliance Lead

Johnson & Johnson MedTech; Raritan (NJ); On-site; USD 94,000 - 152,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

Retirement plan (401k)

Job summary

Johnson & Johnson MedTech is seeking a Staff Source Compliance Specialist to establish and maintain a robust compliance program across Purchasing Controls, aligning with regulatory requirements and corporate policies.

You will lead internal and external audit readiness, manage CAPA and observations, and act as the SPOC for Audit Readiness, coordinating with sites and regions to ensure timely corrective actions and continuous improvement.

Qualifications

• Strong Communications Skills in English (Written and Oral)
• A minimum of a bachelor’s degree in engineering, Applied Science or a related technical and quality field is required.
• A minimum of 4 years of work experience in a highly regulated Industry is required.
• Practical experience with GMP documentation and writing skills in the FDA regulated environment is required.
• At least 2 years of experience in external audit readiness and management, is preferred.

Responsibilities

• Lead and manage internal/external audit readiness activities to always ensure readiness.
• Partner with site leadership to support internal/external audits: e.g. Notified Body, Health Authority, Ministry of Health, FDA, Regulatory Agency, JJRC or ERC audits of the sites.
• Provide timely information to support the internal/external audit/inspection process.
• Ensure external audit results are reported to management having responsibility for the matters audited.

Skills

English

Education

Bachelor’s degree in engineering, Applied Science or related technical and quality field

Job description

Johnson & Johnson MedTech is seeking a Staff Source Compliance Specialist to establish and maintain a robust compliance program across Purchasing Controls, aligning with regulatory requirements and corporate policies.

You will lead internal and external audit readiness, manage CAPA and observations, and act as the SPOC for Audit Readiness, coordinating with sites and regions to ensure timely corrective actions and continuous improvement.