Supervisor, Quality Assurance – Operations (2nd shift)
On-siteBeloit, Wisconsin, United States
Job Summary
Lead daily Quality Assurance operations and coordinate team activities to ensure compliance with GMP regulations and company standards. Supervise, coach, and train QA staff while assigning and monitoring work to support departmental objectives. Oversee investigations, CAPAs, change controls, and other quality system activities, maintaining audit readiness for internal and external responses. Effectively communicate safety and quality issues raised by customers or staff in a timely manner. Drive improvements to quality processes, systems, and operational efficiency through continuous improvement initiatives and risk management. Complete performance evaluations for direct reports and conduct regular team meetings to provide feedback.
Required Qualifications
- Bachelor's degree in chemistry, Biology, or other related scientific discipline
- Minimum of six (6) years of GMP-related experience in biopharmaceutical, pharmaceutical, or related industry
- Direct quality experience
- One (1) year of direct leadership experience
- Working knowledge of applicable regulations, including 21 CFR Parts 210, 211, and 11
- ICH guidelines
Desired Qualifications
- Prior experience supervising Quality Assurance personnel in a regulated GMP manufacturing environment
- Experience leading investigations, CAPAs, change controls, and audit activities
- Demonstrated experience driving continuous improvement, risk management, or lean manufacturing initiatives
- Strong knowledge of pharmaceutical or biopharmaceutical manufacturing processes and quality systems
- American Society of Quality (ASQ) certification
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