Manager Source Regulatory Compliance

Manager Source Regulatory Compliance

Johnson & Johnson | Dallas, TX, 75201, US
Salary Range:$113,000 – $146,000 Salary range estimated by Zippia

Posted 11 days ago

Apply Now

Description

DePuy Synthes Companies of Johnson & Johnson is recruiting for a Manager Source Regulatory Compliance, located in MedTech Sites in the US in the following states: PA, MA, NJ, FL, IN, CA, TX, OH, GA, TN or CO.

DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com .

The DePuy Synthes Source Regulatory Compliance Manager will ensure the execution of compliance activities including the receipt and acceptance of a robust Supplier Audit Response for identified audit observations. Supports in the management, tracking to closure of Supplier's commitments to mitigation of identified risks. Supports in the completion of Follow Up reports related to the tracking and completion of External Manufacturing commitments taken to mitigate identified risks. Provides support in the execution and continuous improvement of Source Compliance programs. Maintains and continually improves a robust Source Compliance Management System in support of DePuy Synthes' business strategy and objectives. Provides leadership on the standardization of best practices in Source Compliance, engages and aligns strategies with business partners across MedTech and its suppliers. The DePuy Synthes Source Regulatory Compliance Manager may execute audits of DePuy Synthes sites as part of the Internal Audit program.

Key Responsibilities:

* Partner with stakeholders (e.g., Source Quality, Source, Franchise Quality, Quality Systems, Manufacturing, and other cross functional business functions.) for the identification of potential quality or compliance issues and development of corrective action plans. Monitor the effective and timely implementation of these corrective action plans.
* Proactively engages with suppliers to develop a robust Supplier Audit Response.
* Tracks action plans to closure and issues Follow Up Reports in accordance with procedural requirements
* Drive compliance performance improvement of suppliers by identifying capability challenges and partnering with Source Quality in the development of quality improvement plans.
* Ensures execution of compliant purchasing controls for suppliers
* May conduct Internal Audits of DePuy Synthes sites and issue audit reports
* Supports the develop of strategic quality and compliance goals, assure management oversight and governance, and drive organizational capabilities to build compliance expertise and guidance.
* Provide periodic data and analytics to our business partners, including compliance data & current global health authority trends that enable the organization can deliver on quality and compliance commitments. Develop proactive approaches to address regulatory trends.
* Assures compliance with regulatory requirements and internal Johnson and Johnson and Medical Device procedures by supporting Internal and External Audits, audits at Supplier facilities and Data Reviews.
* Ensures and maintains a state of inspection readiness for records within area of responsibility.
* Provides visibility on new Health Authority regulations or changing expectations and results of Health Authority inspections.