Senior Quality Assurance Manager

Our client, a leader in the manufacturing of dietary supplements and pharmaceuticals, is seeking an experienced Senior Quality Assurance Manager to oversee compliance, auditing, and quality systems. This role is ideal for a leader who thrives in a highly regulated environment and has extensive experience managing audits, ensuring FDA compliance, and driving continuous improvement in quality management systems.

Apply to this ad or reach out to Jessica Goodman for more information!

Responsibilities:

• Develop, implement, and maintain quality assurance systems to ensure compliance with FDA regulations (21 CFR Part 11 & Part 10).
• Lead internal and external audits, representing the quality management system in regulatory inspections.
• Manage a team of five, providing leadership, coaching, and development plans.
• Ensure alignment of quality goals between corporate and manufacturing sites.
• Oversee document control and good documentation practices for all products and processes.
• Identify and implement continuous improvements to quality procedures and systems.
• Develop key performance indicators and metrics to track program effectiveness.
• Manage department budgets, staffing, and day-to-day operations.
• Stay up to date on evolving regulations and industry best practices to enhance compliance efforts.

Requirements:

• Bachelor’s degree
• 6 years of quality experience in dietary supplement or pharmaceutical manufacturing.
• 3 years in a management or supervisory role, with experience leading both senior and junior staff.
• Extensive auditing experience, with a strong track record of managing FDA and client audits.
• Professional quality certifications (CQE, CQA, CQM, or RAB) preferred.

This role offers the opportunity to lead a high-performing quality team in a heavily audited environment. If you have the expertise and leadership skills to ensure top-tier compliance and quality, apply today.