Compliance Manager

Description - External

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 COMPLIANCE MANAGER to be in Juarez.**

**Purpose**: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.

**You will be responsible for**:

- 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.

**Qualifications**:
**Qualifications and requirements**:

- Bachelor of Science Degree is required, preferably in technical area.
- Experience in External Audit readiness and management.
- Supervisory experience, preferably QA personnel.
- At least five (5) years of experience in the FDA/ISO/Health Authority-regulated industry (medical devices or pharmaceutical), including 2-3 years of specific experience in QA functions and a management/supervisory role.
- Lead Auditor Certification, highly preferred.
- Expertise on the FDA/ISO/Health Authority Quality System regulations and standards, with the ability to relate these to business/quality issues.
- Ability to make decisions which will effectively support the business and company policies.
- Required proven leadership, teamwork, initiative, and assertiveness skills.
- Excellent written and oral communication skills as well as report writing, presentation and training skills both in English and Spanish.
- Ability to quickly build credibility within the Compliance community, executive management, external regulators, and industry.
- Strong collaboration and influence management skills to partner effectively with Sector functions and across Operating Units.
- Proven track record of demonstrating collaboration across the organization and at all levels.