Senior Quality Assurance Manager – Menomonie, WI
Pay: $110,000 – $130,000/year + Bonus
Schedule:
Monday – Friday | 8:00 AM – 5:00 PMRelocation Bonus: Up to $10,000 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!
