Quality Assurance Manager

Overview Reporting to the VP Quality Regulatory Affairs, the Quality Assurance Manager for our pharmaceutical/healthcare manufacturing client in Kingwood, TX will be tasked with ensuring Quality standards are met or exceeded in all facets of the operation. Partner internally in the development and implementation of new or adjusted quality standards, policies, and procedures, as required. Oversee a team of 4 quality administrators between two smaller facilities. This role is on-site in Kingwood. Responsibilities 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. Review and monitor 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 implementing changes, in partnership with corporate QRA and local operations teams. Related Duties Take a lead role in internal/external Audit Program. Perform Quality Department tasks as the functional back-up. Assist with other assigned tasks. Minimum Qualifications Training and Experience 2 years of relevant experience in a drug manufacturing or pharmaceutical distribution company. Previous experience as a supervisor or manager leading teams and successfully working cross-functionally to achieve department goals. Knowledge, Abilities and Skills Proficient in Microsoft Office Suite (Excel, Power Point, Word and Outlook, Project, Statistical Tools) Strong attention to detail. Excellent leadership skills. Ability to work in a team environment as well as alone with little direction. Excellent verbal and written communication skills to all levels of the organization. Strong organizational, prioritization, and problem solving skills required. Position Details Seniority level: Mid-Senior level Employment type: Full-time Job function: Quality Assurance Industries: Pharmaceutical Manufacturing #J-18808-Ljbffr