Responsibilities

• Provide daily oversight of QA teams supporting all production and processing areas.
• Develop and monitor KPIs for batch documentation review, Right First Time (RFT), and timely batch release.
• Lead department resource planning, talent development, and budget management for QA personnel.
• Oversee investigations of product complaints and manufacturing discrepancies; ensure appropriate documentation and follow-up.
• Review root-cause analyses and problem-solving activities to ensure effective corrective and preventive actions (CAPAs).
• Approve investigations, CAPAs, SOPs, Change Controls, protocols, and reports from a QA perspective.
• Ensure all QA documentation is complete, accurate, and compliant with regulatory requirements.
• Coordinate preparation, review, and approval of Annual Product Quality Reports and relevant quality metrics/KPIs.
• Support and participate in FDA and other regulatory inspections, including providing required documentation and responses.
• Conduct pre-inspection reviews of operations and follow up on corrective actions as needed.

Qualifications

• Bachelor’s degree required.
• Minimum of 6 years of progressive experience in Quality Assurance/Quality Control within a regulated industry.
• At least 3 years of experience in a managerial or leadership role.
• Strong knowledge of GMP compliance and pharmaceutical manufacturing processes.
• Experience with sterile injectables or radiopharmaceuticals is highly desirable.
• Proven ability to lead teams, manage investigations, and drive continuous improvement in quality systems.