Sr. Manager, Quality Assurance

Position Overview

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

What You'll Do

• Act as the site's Sr. 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 compliance of two sites.
• 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.
• 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 implementing changes, in partnership with corporate QRA and local operations teams.

Qualifications: What You'll Bring

• Bachelor's degree in technical field.
• Minimum of 3 Years of experience managing manufacturing and/or distribution of pharmaceuticals.
• Minimum of 3 Years of experience having direct responsibility for managing a Quality group.
• Direct experience managing FDA or DEA Inspections.
• Demonstrated proficiency in verbal and written communication in English, with the ability to convey information clearly, accurately, and professionally across all levels of the organization.

Travel Requirements

Up to 15%