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The Director, GLP/GMP Quality will be responsible for all aspects of Quality Assurance (QA), GLP/GMP compliance, and Quality Control (QC) of the company’s products. The Director will play a pivotal role in ensuring that our operations comply with GLP & GMP regulations, maintaining the highest standards of quality and integrity in our research and development processes.


Essential Duties and responsibilities

Leadership and Strategy:
Develop and implement a comprehensive GLP/GMP quality management strategy aligned with the company's objectives.
Provide leadership and direction to the GLP/GMP quality team, fostering a culture of excellence, compliance, and continuous improvement.
Regulatory Compliance:
Stay current with GLP/GMP regulations and guidelines and ensure company-wide adherence to GLP/GMP standards.
Maintain a proactive approach to anticipate and address regulatory changes and updates.
Quality Systems Management:
Oversee the design, development, and maintenance of GLP/GMP quality systems, policies, and procedures.
Collaborate with cross-functional teams to integrate quality practices into laboratory operations.
Audits and Inspections:
Prepare for and manage GLP/GMP audits and inspections, ensuring successful outcomes and timely resolution of any findings.
Conduct internal audits to assess GLP/GMP compliance and identify areas for improvement.
Training and Education:
Develop and deliver GLP/GMP training programs to ensure all employees understand and follow GLP/GMP guidelines.
Foster a culture of quality awareness throughout the organization.
Documentation and Recordkeeping:
Ensure the accurate and timely documentation of all GLP/GMP-related activities and data.
Establish robust recordkeeping practices to meet global regulatory requirements.
Quality Metrics and Performance:
Define key performance indicators (KPIs) to measure and report on GLP/GMP quality performance.
Continuously analyze data and metrics to drive process improvements and efficiency.
Risk Management:
Identify potential quality-related risks and develop risk mitigation plans.
Collaborate with cross-functional teams to address and resolve quality issues.
Vendor Management:
Manage relationships with external vendors and service providers to ensure GLP/GMP compliance in outsourced activities.
Conduct vendor audits as necessary.