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.

A Bachelor's degree in a relevant scientific field is required; a Master's degree or Ph.D. is preferred.
10 + years of experience in GLP/GMP quality management in manufacturing/laboratory or pharmaceutical settings.
Proven leadership and management skills, with a track record of building and leading high-performing teams.
In-depth knowledge of GLP/GMP regulations, guidelines, and industry best practices.
Strong analytical and problem-solving abilities with a results-driven approach.
Excellent communication and interpersonal skills to effectively collaborate with various departments and external partners.
Strong organizational skills and attention to detail.
Certification in Quality Management or relevant fields is a plus.