Senor Quality Assurance Manager

Senior Quality Assurance Manager

We're hiring an experienced Senior Quality Assurance Manager to lead quality systems and regulatory compliance at a growing pharmaceutical manufacturing facility in Menomonie, WI. This leadership role is ideal for a quality professional with a strong background in FDA-regulated manufacturing who is passionate about driving compliance, continuous improvement, and operational excellence.

Core Responsibilities

• Lead and maintain site quality systems to ensure compliance with current GMP regulations and applicable industry standards.
• Oversee document control, including SOPs, batch records, specifications, calibration records, and quality documentation.
• Support quality oversight for manufacturing, testing, validation, and product release activities.
• Manage investigations related to deviations, CAPAs, customer complaints, change controls, and quality events.
• Review and approve validation plans, protocols, reports, and other quality documentation.
• Plan and conduct internal audits while supporting supplier qualification and external audit activities.
• Ensure processes are in place for product recalls, material inspections, and regulatory documentation.
• Partner with cross-functional teams to strengthen quality systems and drive continuous improvement initiatives.

Qualifications

• Bachelor's degree in Life Sciences, Chemistry, Engineering, or a related technical field.
• 10+ years of Quality Assurance experience in pharmaceutical, biotechnology, or regulated medical device manufacturing.
• Strong knowledge of FDA cGMP regulations, 21 CFR Parts 11, 210, and 211, along with ICH and quality risk management principles.
• Experience with validation programs, electronic Quality Management Systems (eQMS), and Part 11 compliant systems.
• Excellent leadership, communication, organizational, and problem-solving skills.
• Advanced Microsoft Office skills, including Excel, with the ability to manage multiple priorities in a fast-paced environment.

Join a company committed to quality, innovation, and continuous growth. If you're ready to make an impact in a leadership role with competitive compensation and bonus potential, apply today!