Director Quality Control

Role Summary

Director Quality Control

Lead and support all quality control activities at the Covington site, overseeing analytical chemistry, microbiology, and laboratory best practices to ensure product safety, compliance, and continuous improvement. Report to the Site Quality Head and champion Takeda’s Quality Culture.

Responsibilities

• Lead and manage the Quality Control (QC) Laboratory, including the Analytical Chemistry and Microbiology teams.
• Develop and uphold quality control processes to guarantee product safety and compliance.
• Manage a QC team responsible for 24/7 testing of raw materials, intermediates, and finished products.
• Ensure all operations meet internal and external (regulatory) quality standards and stay current with new requirements.
• Hire, develop, and recognize technical staff; foster a culture of growth and acknowledgment.
• Serve as a key advisor and handle technical issues and scheduling for the QC team.
• Evaluate the effectiveness of quality control activities with site leadership.
• Lead and drive continuous improvement initiatives focused on quality, reliability, and cost savings, including digital projects.
• Manage the budget for the QC department.
• Develop and maintain the site contamination control program with a focus on sterility assurance.

Qualifications

• Bachelor‚Äôs degree in science, engineering, or a related technical field (or equivalent experience).
• At least 10 years of relevant experience, including 7+ years in a leadership role.
• Strong background in managing large, multi-function laboratories and extensive experience in Analytical Chemistry.
• Solid understanding of regulatory requirements (FDA, EMA, cGMP, GDDP).
• Experience managing regulatory inspections and audit readiness.
• Familiarity with laboratory testing for endotoxin and sterility (preferred).
• Effective at managing budgets and team development.
• Experience with digital and process improvement initiatives.

Skills

• Leadership and people management
• Quality assurance and regulatory compliance
• Analytical chemistry and microbiology expertise
• Budgeting and resource planning
• Continuous improvement and digital project execution

Education

• Bachelor‚Äôs degree in science, engineering, or a related technical field (or equivalent experience).

Additional Requirements

• Work in a clean, controlled environment that requires special clothing (gowning, PPE).
• Must not wear make-up, jewelry, contact lenses, nail polish, or artificial nails in manufacturing areas.
• Be comfortable working in areas that may be cold, hot, or have confined spaces; clean room and variable storage conditions apply.
• Ability to work multiple shifts, including weekends or overtime as needed.
• Up to 10% travel may be required.
• Potential exposure to chemicals and biological agents that require specific PPE.