Position: Quality Director
Location: Singapore
Company Overview: Our client is a leading pharmaceutical manufacturing organization, committed to delivering high-quality medications and healthcare solutions.
Job Summary: The Quality Director will oversee and manage all aspects of quality assurance and control within the organization. This role ensures that all manufacturing processes comply with regulatory standards and meet the highest quality benchmarks. The ideal candidate will have extensive experience in pharmaceutical manufacturing, a deep understanding of regulatory requirements, and a strong leadership acumen.
Key Responsibilities:
Quality Management Systems: Develop, implement, and maintain comprehensive quality management systems (QMS) to ensure compliance with local and international regulations (e.g., FDA, EMA, HSA).
Regulatory Compliance: Ensure all manufacturing processes, products, and documentation comply with regulatory requirements and industry standards.
Audits and Inspections: Lead and coordinate internal and external audits and regulatory inspections. Ensure timely and effective responses to audit findings and implement corrective actions.
Team Leadership: Manage and mentor the quality assurance and quality control teams. Foster a culture of continuous improvement and quality excellence.
Quality Control: Oversee the testing and validation of raw materials, in-process samples, and finished products to ensure they meet quality specifications.
Risk Management: Identify potential quality risks and develop mitigation strategies. Conduct root cause analysis and implement corrective and preventive actions (CAPA) as needed.
Documentation: Ensure accurate and complete documentation of all quality-related activities. Maintain and update quality manuals, standard operating procedures (SOPs), and other relevant documents.
Training: Develop and conduct training programs for staff on quality standards, processes, and regulatory requirements.
Continuous Improvement: Lead initiatives to improve product quality, operational efficiency, and compliance. Implement best practices and industry advancements.
Qualifications:
Education: Bachelor's or Master's degree in Pharmacy, Chemistry, Biochemistry, or a related field.
Experience: Minimum of 10 years of experience in quality assurance/control within the pharmaceutical manufacturing industry, with at least 5 years in a leadership role.
Knowledge: In-depth knowledge of pharmaceutical manufacturing processes, regulatory requirements, and quality standards (e.g., GMP, ISO).
Skills: Excellent leadership, communication, and problem-solving skills. Strong attention to detail and ability to work in a fast-paced environment.
Certifications: Relevant certifications in quality management or regulatory affairs are a plus.
