Our Client, a leading manufacturer in the Chicago area, is seeking a seasoned Vice President of Quality Assurance to oversee and manage their comprehensive Quality Assurance and Regulatory Compliance program across all manufacturing facilities. Reporting directly to the President, the VP of Quality will be responsible for ensuring compliance with FDA regulations. This role will lead the Quality Assurance team in driving excellence across all aspects of the quality function, from inspections and validations to audits and corrective actions.
Key Responsibilities:
- Quality and Compliance Management: Lead the North American quality and compliance initiatives, ensuring all GxP systems meet regulatory standards for products manufactured and distributed from the Client’s facilities. Manage compliance with FDA regulations.
- Leadership and Strategy: Oversee the Quality Assurance and Quality Control departments, including strategy development, talent management, and departmental budgeting. Accountable for ensuring the timely testing, release, and labeling of products, as well as maintaining strong relationships with regulators and customers.
- Quality Management System (QMS): Manage the Quality Management System and Documentation Department, overseeing the review, approval, and retention of procedures and records. This includes company-wide training, assessment of training needs, and management of employee training records, as well as supporting computer system validation and business continuity documentation.
- Compliance Metrics and Trend Analysis: Ensure compliance metrics are robust and reflective of product lifecycle and new product standards. Conduct trend analysis of audit and inspection observations, and communicate findings promptly to relevant teams.
- Regulatory Surveillance and Continuous Improvement: Monitor global regulatory developments and update procedures and policies accordingly. Stay abreast of scientific and industry trends, integrating relevant advancements into quality strategies and operations.
Required Skills and Experience:
- Deep expertise in OTC, supplement, and food GMP requirements, with significant experience in quality management in a regulated manufacturing environment.
- Proven ability to lead and manage a diverse team, driving compliance and quality improvements across multiple facilities.
- Willingness and ability to travel domestically and internationally as needed to support audits and QA system implementations.
