Quality Assurance Manager (38511)

Site Overview:

PuraGraft represents the leading manufacturers of biomaterial solutions for bone and tissue regeneration. No single material can suit all medical requirements and indications. However, through PuraGraft® you have access to the widest choices of products.

Position Overview:

Reporting to the VP Quality Regulatory Affairs, the Quality Assurance Manager will be tasked with ensuring Quality standards are met or exceeded in all facets of the operation.  He/she will partner internally in the development and implementation of new or adjusted quality standards, policies, and procedures, as required.

Essential Duties:

• Act as the site’s Quality and Compliance Leader, and when necessary, as the site’s Designated Management Representative to ensure compliance with all regulatory, corporate and facility requirements.

• Ensure outstanding Quality System performance via monitoring and measuring of process performance, and driving any appropriate action, including issuing and follow-up on activities required for sourcing, warehousing, and distributing pharmaceuticals.

• Supervise & Manage Quality Associates and develop culture of collaboration and cross-functional success within the department and business. 

• Reviews and monitors Quality metrics and reports trends, to determine if there is a need to escalate issues to the management.

• Perform, review and monitor the Quality Management processes which includes but is not limited to:

• Ensure compliance with FDA, DEA and BOP requirements, including DSCSA traceability of pharmaceuticals.

• Oversee Regulatory activities associated with distribution licensing, drug distribution reports, and permits for warehousing and distribution of controlled substances.

• inspection and product release, label approval, calibration, warehousing controls, record retention, document control, training, control of non-conforming product, quarantined Products, control of access and drugs storage, including temperature monitoring.

• Host and manage internal and external audits. Ensure the site’s readiness for assessments and lead implementation of corrective actions.

• Effectively assess processes and identify opportunities for improvement.

• Review, Analyze and Report Statistical findings through critical thought and storytelling of key findings and opportunities to all levels within a matrixed organization.

• Partner with other departments to identify critical to quality metrics, and support the operationalization of monitoring and management to deliver improved performance across processes.

• Create effective and compelling visual materials/presentations that support the process/product improvement impact to the organization and adequately represent the impact to quality, cost and time.

• Define, track, and monitor key success measures associated with Quality Management Systems. Successfully deploy and support change management and appropriate training plans.

• Manage document control functions, including creation, review, and approval of procedures, work instructions and all other documentation for the Quality System.

• Manage the complaint handling system, including trending and review to identify opportunities for improvement.

• Manage the training of the Site, by maintaining the training log, tracking training completion of training by site personnel, creating training content and hosting group training as needed.

• Develop and host the Quarterly Management Review

• Manage the Recall process, from notification, tracking responses & expenses, reporting, and closure.

• Develop, refine, and/or maintain quality standards, policies, and procedures for the facility, including identifying, recommending, and fully implem