Associate Director – QC – IAPI

Role Summary

The Quality Control (QC) Associate Director leads leaders and teams of analysts to deliver test results within sample turn-around times while maintaining high safety and quality standards. The role requires cross-functional collaboration with Technical Services, manufacturing, and Quality Assurance to drive Operational Excellence in the laboratories. Onsite presence at the Indianapolis API site is required.

Responsibilities

• Implement and sustain Operational Excellence within the laboratory.
• Ensure appropriate resourcing to meet business requirements.
• Ensure all laboratory operations comply with applicable procedures and standards.
• Provide leadership for development, implementation, and execution of quality systems.
• Define and monitor productivity and continuous improvement opportunities.
• Assist in business plan development and execution.
• Maintain safety programs for the laboratory.
• Provide leadership for investigations, including robust corrective and preventive actions.

• Define and maintain inspection readiness activities.
• Interact with regulatory agencies during GMP inspections as appropriate.

• Recruit and retain an effective, diverse staff.
• Develop a staffing model for each laboratory.
• Supervise/coaching/develop personnel, including leaders within the reporting structure.
• Facilitate the performance management process.
• Ensure an inclusive environment.

Qualifications

• Required: Bachelor‚Äôs Degree in a Scientific Discipline.
• Required: Minimum 3 years of experience in a GMP laboratory.
• Preferred: Previous supervisory experience.
• Preferred: Experience in Lean implementation.
• Preferred: Strong written and oral communication skills.
• Preferred: Demonstrated leadership skills (decision making, prioritization, mentoring, problem solving, conflict resolution).
• Preferred: Knowledge of computer applications for laboratories.

Education

• Bachelor‚Äôs Degree in a Scientific Discipline (required)

Additional Requirements

• This position requires onsite presence.
• Must complete Learning Plan for Associate Director ‚Äì QC ‚Äì IAPI.
• Available to provide 24 hour support.