Quality Systems Compliance Manager

At **Johnson & Johnson,** the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity.Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years.Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world.When You Join Johnson & Johnson, Your Move Could Mean Our Next Breakthrough.At Johnson & Johnson Medical Devices Companies, we are using our breadth, scale, and experience to reimagine the way healthcare is delivered and to help people live longer, healthier lives.In a radically changing environment, we are making connections across science and technology to combine our own expertise in surgery, orthopedics, and interventional solutions with the big ideas of others to design and deliver doctor and patient-centric products and solutions.We are in this for life.We are changing the trajectory of human health, **YOU CAN TOO **.**We are searching for the best talent for REGULATORY COMPLIANCE MANAGERto be in Juárez****Porpuse**:Under the supervision of the Senior Regulatory Compliance Manager, the Regulatory Compliance Manager 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.Responsabilities:- Lead and manage external audit/inspection readiness activities to ensure site readiness at all times including audit logistics, front room/back room arrangements, identifying/preparing SME's, etc.- Partner with site leadership to host external audits/inspections of the site e.g. Notified Body, Health Authority, Ministry of Health, FDA, Regulatory Agency, or JJRC/ERC.- Assess the risk and applicability of external audit/inspection observations from other J&J facilities to determine impact to the site.- Schedule and manage mock external audits/inspections as part of the External Audit/Inspection Readiness activities.- Provide timely information to support the external audit/inspection process, including those that maybe taking place at other sites / locations.- Ensure external audit/inspection results are reported to management having responsibility for the matters audited.Provide daily communications regarding potential non-conformities or observations.- Take the lead and provide guidance to prepare responses to any regulatory agency notification or correspondence associated with the site.- Take the lead and provide guidance to ensure timely and adequate responses to external audit/inspection observations related to the site, including failure investigations, root cause analysis, risk assessments, correction, corrective and preventive action plans, monitor and drive on-time completion of all action plans, perform follow-up with owners, and perform effectiveness monitoring and closure.- Ensure timely and accurate reporting and publishing of external audit metrics.Drive compliance and improvements in metrics targets.**Internal Audit Program Management**- Establish and manage an effective internal audit program for the site.- Ensure the resources needed to execute the internal audit schedule are provided.- Ensure internal audits are executed according to the established internal audit procedures.Ensure independence between the internal auditors and the activities being audited.- Provide guidance on the interpretation of the regulatory requirements.- Provide management oversight and direction to the internal auditors for the execution of the audit process.- Ensure internal audit results are reported to management having responsibility for the matters audited.- Ensure timely and adequate responses to internal audit observations, including failure investigations, root cause analysis, risk assessments, correction, corrective and preventive action plans, monitor and drive on-time completion of all action plans, perform follow-up with owners, and perform effectiveness monitoring and closure- Ensure timely and accurate reporting and publishing of internal audit metrics.Drive compliance and improvements in metrics targets.- Ensure documentation and records related to the internal audit program are maintained.- Ensure all quality system elements/processes applicable to the site are audited and appropriate actions are taken to meet the business and regulatory requirements.- Execute/coordinate program(s) for qualification and training of internal auditors.Assess qualification of internal auditors on a periodic basis.Note: Programs can include franchise, supply chain, sector, and/or enterprise elements.**Qualifications**:**REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS **_*