Source Compliance Specialist

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, and solutions are personal.

Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Quality

Supplier Quality

Professional

Cornelia, Georgia, United States of America, Guaynabo, Puerto Rico, United States of America, Raritan, New Jersey, United States of America, San Angelo, Texas, United States of America

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at

The Staff Source Compliance Specialist, under the supervision of the Source Quality System Lead, is responsible for establishing and maintaining a robust compliance program to ensure compliance with all applicable regulatory requirements, company policies and procedures, and J&J Corporate requirements.

The Staff Source Compliance Specialist will also be responsible to lead and oversee NC, CAPA, Escalations and internal/external observations activities as defined in Purchasing Control Quality Systems Procedures. The Staff Source Compliance Specialist will also act as the single point of contact (SPOC) for the Audit Readiness and Audit Support activities related to the Source Quality global team.

• Lead and manage internal/external audit readiness activities to always ensure readiness. These activities include audit logistics, front room/back-room arrangements, identifying/preparing SME’s, support to sites during audits etc.
• 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. Provide daily internal/external audit/inspection communications regarding potential non-conformities or observations.
• Provide guidance to prepare responses to any internal/external audit/inspection or other regulatory notification associated with Purchasing Controls.
• Ensure timely and adequate responses to internal/external audit observations related to Purchasing Controls, including failure investigations, root cause analysis and correction/corrective/preventive action plans, monitor and drive on-time completion of all action plans, perform follow-up with owners, and perform effectiveness monitoring and closure.
• Where appropriate, ensure compliance representation on required sector and/or enterprise teams/projects.
• Support the effective deployment of J&J Quality System standards at the site.
• Connect and collaborate with the compliance teams of all sites and regions.
• Escalate quality issues in accordance with established procedures.
• Provide routine communication, updates and escalation to site and franchise organizational management regarding compliance trends and initiatives.
• Responsible for the proactive identification and alerting the management of quality issues in time to resolve potential adverse effects to the customer, company image/reputation and/or the business.
• Support implementation of new regulations and standards.
• Maintain current knowledge of regulatory changes through industry publications, seminars, professional affiliations and industry meetings.
• Proactively communicate organizational and regulatory compliance related changes that may impact Purchasing Controls. Ensure feedback and alignment with said…