Responsible for assuring company wide compliance with FDA/GMP/QSR and FDA and ISO 9001/13485/CMDR/CE commitments. Failure to identify and recommend corrective actions could result in legal enforcement action, critical delays in schedules and/or departmental operations and may jeopardize overall business activities.
• Ownership of the Corrective and Preventive Action system.
• Management of technical staff directed to closing and audit of CAPAs.
• Communication of CAPA status to executive management.
• Management of OEM customer Supplier Corrective Action Reports.
• Communication to OEM customers of status of SCARs.
• Management of technical staff dedicated to completion of OEM SCARs and response to OEM customers
- Lead continuous improvement of Quality Systems, such as (CAPA, Deviation Management, and Change Management), and direct the efforts to develop, implement and maintain compliant and effective Quality Systems.
- Lead cross-functional teams to complete projects, address quality issues and implement quality system improvements.
- Identify compliance gaps and lead focused teams to resolve compliance issues.
- Lead department projects of varying complexity.
- Support the promotion, socialization, development and implementation of Corrective and Preventative Action system.
- Assign, manage and review progress and accuracy of work for an individual, or a group of employees.
- Lead by example to foster a commitment to quality in personnel, and a culture of quality within the organization.
- Interact and influence peers to ensure successful project completion.
- Maintain current knowledge of Compliance program and of applicable company standard operating procedures for areas of responsibility.
- Provide guidance on interpretation and application of specified QA compliance regulations.
- Position requires a 4-year degree in a technical/science area; an advanced degree is preferred.
- More then 6 years in a regulated industry with 3 or more years in a management position is also required.
- Significant experience with quality systems in an IVD/Medical device environment is also required.
- Incumbent must possess strong interpersonal and communication skills.
- Demonstrates in-depth knowledge of Good Manufacturing Practices (GMPs).
- Demonstrates in-depth knowledge of QA systems principles, concepts, industry practices, and standards.
- Demonstrates excellent verbal, written, and interpersonal communication skills.
- Keen understanding of international quality systems regulations to adopt best in class systems/processes and drive continuous improvement initiatives.
- Demonstrated experience as a change agent in driving complex change, understanding the cultural dynamics of the current state of an organization, creating a strategic practical course, balancing the current reality with the need for rapid adoption of the desired future reality which then generates change with a high degree of transformation
- Direct experience with managing key Quality Management System processes, such as CAPA, Deviation Management, Change Management and Management Review
- In-depth understanding of current global regulatory expectations, such as 21CFR Parts 210 & 211 and 21CFR part11
- Excellent organization skills and ability to work on a number of projects to tight timelines.
- Demonstrated leadership skills associated with the management, leadership and development of staff.
- Excellent attention to detail, and ability to consistently meet high standards of quality required in QA Compliance.
- Experience identifying changes, driving improvements and streamlining processes
- Proficient with the Microsoft Word, Excel, PowerPoint and Outlook.