The Quality Assurance (QA) Manager will serve as the QA leader of the Company鈥檚 operational site, in Alexandria, MN, dedicated to the successful delivery of site quality goals and objectives. This individual leads the daily operations of a team of QA staff responsible for confirming satisfactory product design verification, validation, and transfer; documentation control for release of commercialized product; suitability of local quality management system (QMS); change and risk management; corrective and preventive actions; complaint resolution and root cause investigation; monitoring and reporting of relevant data and metrics. As directed by leadership, this individual may direct QA operations for more than one operational site. This role is expected to serve as the primary QA business partner to site-focused teams within the Manufacturing, Supply Chain, EH&S, Commercial, Product Management, R&D, and Customer Service functions, among others.
In partnership with respective HR, operational leadership, and cross-functional stakeholders, this individual is expected to foster a positive work environment and a culture of ownership, continuous improvement, and accountability.
To perform this job successfully, an individual must be able to perform each of the following essential functions satisfactorily:
- Provide daily leadership to a team of direct reports in the areas of safety, efficiency, quality control, cost, resources, and engagement in support of the organization鈥檚 commercial and operational activities
- Responsible for personnel activities of direct reports including business objective setting, staffing, resource planning, training, performance management, and staff development and effectiveness
- Ensure effectiveness of local quality management system (QMS), while also ensuring the highest standard of product quality and site compliance with applicable regulatory and customer requirements
- In partnership with QA leadership, support the development, implementation, and scaling of global and local QMS, in alignment with best practices and business needs, across the site functions
- Serve as Quality Management Representative for operational site(s) under direct remit, including hosting third-party inspections and audits and chairing periodic management reviews of the QMS
- In partnership with site and functional leadership, develop and implement key performance indicators (KPI鈥檚) relevant to the site QMS and QA function; oversee the regular review, analysis, and reporting on KPI鈥檚 for team(s) and area(s) under direct remit
- Ensure high-quality data delivery and effective communication to customers, internal or external
- In partnership with direct management, develop, execute, and review strategies to improve the effectiveness of local QA procedures, processes, training, and business reporting
- Ensure effective delivery of, and timely resolutions resulting from, local operational processes which include document and change control; corrective and preventive actions (CAPA鈥檚); manufacturing non-conformance; risk management and business continuity; complaint resolution; root cause investigations; quality standard certification and maintenance; product design verification, validation, and transfer
- Oversee the effective delivery of QA and QMS training needs and activities across the site
- Serve as business partner, with the relevant subject matter expertise, to local leaders and functional stakeholders
- Support deployment of global practices and platforms; may lead global projects as directed
- Perform other duties as required to meet business needs