Quality Manager

Salary Range: 80000 to 100000 (Currency: USD) (Pay period: per-year-salary)

Responsibilities

• Lead, manage, and oversee the day-to-day operations of the Quality Assurance and Quality Control teams.
• Develop, implement, and maintain the Quality Management System (QMS) to ensure compliance with regulatory requirements, including FDA, EMA, ICH, and other applicable standards.
• Ensure compliance with GMP guidelines and maintain adherence to internal and external auditing processes.
• Review and approve batch records, specifications, and test protocols to ensure product quality standards are met.
• Conduct investigations and root-cause analysis of quality issues, deviations, and customer complaints; implement corrective and preventive actions (CAPAs).
• Collaborate with cross-functional teams (production, R&D, regulatory affairs, etc.) to develop and maintain product quality plans.
• Oversee the validation and qualification of manufacturing processes and equipment.
• Perform regular internal audits and inspections, and coordinate external audits with regulatory agencies and customers.
• Maintain up-to-date knowledge of regulatory changes and trends in the pharmaceutical industry to ensure the company remains compliant.
• Develop and execute training programs for employees in quality standards, procedures, and best practices.
• Monitor and track key quality performance indicators (KPIs) to identify areas for continuous improvement.
• Manage the preparation and submission of regulatory documents related to quality and manufacturing processes.

Requirements

• Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Engineering, or a related field (Master’s preferred).
• Minimum of 5 years of experience in quality management within the pharmaceutical manufacturing industry.
• In-depth knowledge of GMP, FDA, EMA, ICH regulations, and other global pharmaceutical standards.
• Strong leadership and team management skills, with experience in managing and developing quality assurance teams.
• Experience with quality control, process validation, and regulatory audits.
• Proficiency in using quality management software and systems.
• Excellent analytical and problem-solving skills, with a strong attention to detail.