Qualifications

• Bachelor's degree in a scientific discipline.
• 10+ years in Quality Assurance within a GMP-regulated environment.
• 5+ years of leadership experience in GMP manufacturing or distribution preferred.
• Ability to read and interpret technical documents and regulations.
• Strong written and verbal communication skills.
• Proven organizational and multitasking abilities with minimal supervision.
• High attention to detail and accuracy.
• Familiarity with ICH Q7 and 21 CFR regulations, including Part 11, 210, and 211.
• Preferred ASQC quality certifications or ISO 9000 audit training.

Responsibilities

• Supervise daily warehouse activities for efficient material flow and Quality Assurance completion.
• Oversee labeling systems, compliance training, document control, and equipment calibration.
• Lead investigations, perform root-cause analyses, and develop corrective action plans.
• Assist in internal and external audits and inspections.
• Develop and maintain document storage and retrieval systems.
• Review and approve Quality Operation Processes and GMP documentation.
• Use statistical process control to evaluate trends and prepare KPI reports for management.
• Manage audit items and ensure timely closure of discrepancies.
• Support customer complaints and provide necessary responses as required.
• Mentor junior staff and comply with cGMP regulations.