Quality System Lead

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Job Description:

The Quality Systems Lead oversees the day-to-day operations of the Quality Systems staff. Oversees the development and implementation of processes procedures audits and corrective actions. Ensures effective communication and training are deployed throughout the business. The Quality Systems Lead is responsible for the overall management and effectiveness of the site Document Control Records Management Nonconformance (NC) and Corrective and Preventive Action (CAPA) programs including: Administration of the Document Control Records Management NC and CAPA systems facilitation of the local Data Review Board and Management Reviews coordination and support of NC and CAPA project teams data trending and Change Management/NC/CAPA reporting and communication with management team leaders and auditing bodies.

DUTIES & RESPONSIBILITIES:

In accordance with all applicable federal state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines this position:

Manage the NC and CAPA processes and systems for the site.

Manage the Document Control and Records Management processes for the site.

Manages the implementation and administration of quality management systems in accordance with applicable standards.

Requests data and metrics reports obtained from quality databases and files for inclusion in management reports.

Examines results from management reviews third party inspections and internal audits and approves proposed corrective actions.

Represent the site on the world-wide Document Control Records Management NC and CAPA teams.

Work effectively with other Document Control Records Management NC and CAPA site leaders to ensure consistent systems and processes.

Provide education and mentoring as needed regarding Document Control Records Management NC and CAPA.

Develop and implement measures to monitor the effectiveness of the Document Control Records Management NC and CAPA systems.

Lead quality systems and compliance improvement which result from Internal / External Audits Management Review and / or any other CAPA / NC system indicator.

Participates as a key member in both external and internal audits and is responsible for the local Document Control Records Management NC and CAPA processes and directed inspections.

Represents the site and collaborates with business partners as the CAPA Site Leader.

Facilitates (or delegates Facilitation) and leads the site CAPA Review Board / Data Review Board / Quality Metrics Review / Management Review.

Partner with management to develop and implement meaningful trending of Change Management NC and CAPA performance.

Leverage Process Excellence tools to effectively implement CAPA using a DMAIC approach.

Responsible to mentor both technical and non-technical resources in investigation troubleshooting escalation and resolution of product and process quality issues NC and CAPA.

Supports the continuous improvement of the Document Control Records Management CAPA and NC processes and electronic system for managing CAPA and NCs.

Demonstrate independent understanding and application of core GMP fundamentals including but not limited to: Data Integrity (DI) Good Manufacturing Practices (GMP) and Good Documentation Practices (GDPs).

Responsible for communicating business related issues or opportunities to next management level

Responsible for following all Company guidelines related to Health Safety and Environmental practices as applicable.

For those who supervise or manage a staff responsible for ensuring that subordinates follow all Company guidelines related to Health Safety and Environmental practices and that all resources needed to do so are available and in good condition if applicable

Responsible for ensuring personal and Company compliance with all Federal State local and Company regulations policies and procedures

Performs other duties assigned as needed

EXPERIENCE AND EDUCATION:

University/Bachelors Degree or Equivalent

8 10 years of work experience required

REQUIRED KNOWLEDGE SKILLS ABILITIES CERTIFICATIONS/LICENSES and AFFILIATIONS:

Experience leading NCs and CAPAs.

Experience in Change Management and Document Control.

Experience in Records Management.

Knowledge of regulatory requirements (ISO QSR etc.).

Experience with external auditing bodies.

Process Excellence Green Belt Certification with demonstrated problem-solving and statistics skills preferred

Demonstrated project management skills with strong results orientation required.

Strong communication influencing and presentation skills required.

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