This position manages the Madison, WI site’s quality management system to improve customer satisfaction and to continually improve the site’s product quality & product safety related performance. This individual will be responsible to define and lead compliance requirements to meet both business and strategic needs.
The position supervises the day to day activities of the quality team at the Madison site, implements business unit product quality and product safety improvement strategies at the site level, establishes and publishes appropriate product quality and product safety performance metrics, analyzes performance and recommends improvement programs related to product, process and procedures and coordinates reporting and accurate and timely communication of the quality policy, quality principles, and product quality and safety performance within the site.
The position collaborates with the plant manager to ensure that the site complies with corporate, divisional, and local guidelines and procedures and all regulatory requirements as they pertain to product quality and product safety.
To perform this position successfully, the candidate should be able to perform the following tasks including, but not limited to:
Define, implement, and drive the Madison site’s quality and product safety management systems, associated compliance, and the systems continuous improvement. This includes both quality assurance and quality control.
Manage the development, implementation, and maintenance of integrated management systems and programs based on applicable standards such as ISO FSSC 22000, Dietary Supplement, API and pharmaceutical cGMP standards, and other standards defined by the site and/or business’s strategy.
Work with site leadership to ensure that the site’s established quality and product safety guidelines, policies and procedures are followed effectively. Provide direction and leadership to drive the quality process and compliance.
Ensure audit readiness for quality and product safety related audits including:
Internal audits used to ensure compliance with applicable regulations, cGMP’s, and internal programs.
External quality-related audits of the Madison site conducted by outside agencies, regulatory authorities, or by specific customers.
Vendor audits in cooperation with the corporate / regional quality and product safety organization, as needed.
Accountable for site quality objectives. Collect and analyze sources of quality data for need to initiate corrective or preventive action.
Responsible for review and assessment of management of change (MOC), complaints, non-conformances, deviations, and other quality data for need to perform root cause investigations.
Define program to effectively develop and mentor quality team to ensure compliance and future growth of the business.
Account for budget, cost control, and associated expenses within the quality department.
Work with the Global Pharma Quality Lead to help ensure accurate and timely communication within a global business relative to site and departmental objectives and performance.
Minimum possess the equivalent of a U.S. bachelor’s degree (4-year University degree) in food science, microbiology, biochemistry, or a related field.
Minimum of 7 years of work experience in a dietary supplement or pharmaceutical manufacturing environment performing QA/QC/Regulatory functions.
Strong leadership skills with the ability to lead people in both direct and indirect management relationships.
Knowledge of 21 CFR 111, 210, 211, or 605 compliance requirements.
Proven track record of hosting successful FDA audits is preferred.
Strong project management skills, leadership skills, and the ability to manage multiple priorities and projects.
Good interpersonal skills and the ability to work in a team environment.