Website Johnson & Johnson
The MD Source Compliance Manager is responsible for activities executed under the Source Compliance Organization including the following; will ensure the execution of compliance activities including the receipt and acceptance of a robust supplier response for identified audit observations. They will be responsible for supporting the external inspection and internal audits of the Source Compliance program. Serves on cross site and segment project teams consistent with company goals and objectives to improve overall compliance performance to established metrics and requirements. Supports in the management, tracking to closure of External Manufacturers and Suppliers 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.
- Assists in the development, implementation and continuous improvement of the MD Source Compliance program.
- Ensures timely mitigation of risks identified through Supplier Audit Program.
- Requests and reviews documentation related to Supplier Audit Response for identified audit observations
- Assures that related Source Compliance Quality Records are updated in a timely manner and are compliant with company procedures and policies.
- Ensures and maintains a state of inspection readiness for systems, processes, and procedures within area of responsibility.
- Assist in defining and providing compliance metrics to be used in management reviews, external inquiries and periodic dashboards.
- Proactively engages with external partners to develop a robust Supplier Audit Response.
- Issues Follow Up reports in accordance with procedural requirements.
- Identify process improvements related to standard operating procedures and systems to mitigate risk and drive a quality culture.
- Escalates abnormalities and business-critical information to Source Compliance Leadership
- Responsible for communicating business related issues or opportunities to the next management level
- Performs other duties assigned as needed
- Supports strategic Regulatory Compliance initiatives and projects
- Support Regulatory body audits at both MD sites and suppliers as required.
- Bachelor’s degree in Business, Life Science, Physical Science, or Engineering is required. A Master’s Degree or other Advanced Degree is preferred
- A minimum of 8 or more years of combined experience in Regulatory, Compliance, Quality Management and/or Operations in Medical Devices, Consumer or pharmaceutical environment is required
- Medical Device experience is preferred
- Experience in actively participating in FDA or other Health Authority inspections is required
- Expertise on/detailed knowledge of regulatory requirements in the FDA/ISO/Health Authority-regulated industry (medical devices or pharmaceutical), with the ability to relate them to business/quality issues, is preferred
- Excellent written and oral communication skills, as well as report writing, are required
- Strong collaboration and influence skills to partner effectively both internally and externally are required
- The ability to enter data into databases & systems, as well as the ability to make the complex clear and easily understood by others, is required
- Auditor Certification is a plus
- Demonstrated ability to work remotely and partner globally is required.
- The ability to lead, negotiate and influence others in a complex matrix organization is required
- The ability to foster an effective multi-functional, cross-region, cross-company team environment is required
Company: Johnson & Johnson
Vacancy Type: Full Time
Job Location: Sarasota, FL, US
Application Deadline: N/A