Quality Director
1 week ago
Job Description
Job Description
Job Summary:
The Director of Quality is responsible for leading the development, implementation, and maintenance of quality management systems and processes to ensure the organization delivers products and services that meet or exceed customer expectations and regulatory requirements. This role involves strategic planning, quality assurance, performance monitoring, and continuous improvement initiatives across all functional areas. The Director of Quality serves as a key advisor to executive leadership, driving a culture of quality excellence and operational efficiency throughout the organization.
Key Responsibilities
Leadership and Management:
Provide strategic leadership for the quality function within the organization.
Manage a team of quality professionals, providing guidance, mentoring, and performance feedback.
Develop and implement quality policies, procedures, and initiatives in alignment with organizational goals and regulatory standards.
Developing Quality Systems:
Design, implement, and maintain quality management systems (QMS) to ensure compliance with regulatory requirements such as USFDA, ISO, and other relevant standards.
Quality Assurance:
Oversee the design and implementation of quality assurance programs and systems to ensure compliance with relevant regulations (such as USFDA, EMA, ISO standards) and industry best practices.
Conduct audits and inspections of manufacturing processes, facilities, and documentation to identify areas for improvement and ensure adherence to quality standards.
Manage the process for investigating and resolving quality issues, deviations, and non-conformances, implementing corrective and preventive actions as necessary.
Quality Control:
Establish and maintain robust quality control processes for raw materials, in-process materials, and finished products.
Ensure the accuracy and reliability of analytical methods and testing procedures used in product evaluation and release.
Monitor and analyze quality data to identify trends, assess product quality, and drive continuous improvement efforts.
Regulatory Compliance:
Stay abreast of changes in regulatory requirements and industry guidelines related to quality management and assurance.
Collaborate with regulatory affairs professionals to ensure timely submission of regulatory filings and compliance with regulatory commitments.
Serve as a primary point of contact for regulatory agencies during inspections and audits, ensuring preparedness and facilitating communication.
Quality Training and Education:
Develop and deliver training programs to educate employees on quality standards, procedures, and regulations.
Foster a culture of quality and compliance throughout the organization by promoting awareness and accountability at all levels.
Supplier and Vendor Management:
Establish quality agreements and requirements for suppliers, contractors, and service providers.
Evaluate supplier performance and conduct audits to assess compliance with quality standards and contractual requirements.
Collaborate with procurement and supply chain teams to address quality issues and drive improvements in the supply chain.
Continuous Improvement:
Lead initiatives to identify opportunities for process optimization, cost reduction, and quality enhancement.
Implement quality improvement methodologies such as Six Sigma, Lean, or Total Quality Management to drive efficiency and effectiveness.
Communication and Collaboration:
Collaborate cross-functionally with R&D, manufacturing, regulatory affairs, and other departments to ensure alignment on quality objectives and priorities.
Communicate quality performance metrics, trends, and initiatives to senior management and stakeholders, providing insights and recommendations for action.
Risk Management:
Identify and assess risks to product quality, patient safety, and regulatory compliance, developing risk mitigation strategies and contingency plans.
Monitor emerging risks and trends in the biotechnology industry, proactively addressing potential threats to quality and compliance.
Documentation :
Maintain accurate and up-to-date documentation of quality-related activities, including SOPs, batch records, validation protocols, and quality records.
Ensure that documentation systems and electronic data management systems comply with regulatory requirements for data integrity and traceability.
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