What are the responsibilities and job description for the Quality System Manager position at Harba Solutions Inc.?
Key Responsibilities
- Develop, implement, and maintain a compliant Quality Management System (QMS) aligned with cGMP, GDP, FDA, and ICH requirements
- Oversee document control, change management, deviation handling, CAPA, and training programs
- Conduct and manage internal audits, coordinate customer audits, and support regulatory inspections
- Ensure compliance across all pharmaceutical storage, handling, and distribution activities, including cold chain logistics for biologics and vaccines
- Monitor and ensure the integrity of temperature-controlled shipments, including validation of storage and transportation equipment
- Review and approve investigations, deviations, nonconformances, and customer complaints, including root cause analysis and corrective actions
- Maintain quality performance metrics and prepare management review reports to monitor system effectiveness
- Partner with operations, warehouse, and client service teams to ensure adherence to GDP and cold chain requirements
- Review and approve SOPs, validation protocols, and quality agreements
- Ensure all associates receive appropriate quality and compliance training
- Support continuous improvement initiatives to drive operational excellence and regulatory compliance
Qualifications
- Bachelor’s degree in Life Sciences, Quality Management, Engineering, or a related field (advanced degree preferred)
- 5 years of quality or compliance experience within pharmaceutical manufacturing
- Strong knowledge of cGMP, GDP, FDA, and ICH regulations
- Experience managing quality systems, audits, and regulatory inspections
- Proven ability to interpret and apply regulatory requirements in a regulated logistics environment
- Excellent communication, leadership, and problem-solving skills
- Proficiency with QMS software and standard business tools