Full Job Description
Your Role: Quality Assurance Leader
As a Quality Assurance Leader, you will be part of the Quality organization supporting compliance, document control, and continuous improvement initiatives across the manufacturing site. In this role, you will be responsible for advancing cGMP compliance, strengthening data integrity practices, and leading quality system improvements while developing a high-performing team.
Your Responsibilities:
• Lead and develop a team responsible for production record distribution, reconciliation, and document control activities.
• Drive projects focused on improving cGMP compliance, data integrity, and quality system effectiveness.
• Partner with Manufacturing, Quality, and cross-functional stakeholders to implement process improvements and compliance initiatives.
• Ensure quality records, documentation, and processes meet regulatory and company standards.
• Foster a culture of accountability, collaboration, and continuous improvement within the department.
What You Need to Succeed (minimum qualifications):
• Education: Bachelor's degree in a scientific, technical, or related discipline.
• Experience: Minimum of 5 years of experience in Quality, Compliance, Document Control, or a regulated manufacturing environment.
• Top 2 Skills: Strong project management and organizational skills combined with the ability to lead teams and drive quality improvement initiatives.
What Will Give You a Competitive Edge (preferred qualifications):
• Experience working in a cGMP-regulated manufacturing environment.
• Knowledge of data integrity principles and quality systems.
• Experience leading process improvement or compliance-related projects.
• Previous supervisory, team leadership, or cross-functional project leadership experience.
• Strong interpersonal, communication, and conflict-resolution skills.