Our Client is seeking a highly motivated and experienced Director of Quality to join their growing team. As the Director of Quality, you will play a pivotal role in ensuring the quality and compliance of our pharmaceutical products. You will lead our Quality team, oversee responsibilities for all activities associated with cGMP compliance including incoming quality, laboratories, documentation, training, auditing, manufacturing quality, and validation oversight
The Director of Quality will:
Provide strategic leadership to the Quality team, setting clear goals and expectations, and fostering a culture of excellence and continuous improvement.
Plan and conduct internal and external quality audits to ensure compliance with regulatory standards and identify areas for improvement.
Responsible for the management of all aspects of the site cGMP documentation system.
Ensure compliance with all relevant regulatory requirements, including FDA and other global regulatory agencies, and oversee the preparation and execution of regulatory inspections.
Establish and maintain effective quality systems, including SOPs, document control, change control, and CAPA programs.
Key role in the technical transfer of analytical methods and specifications for new products from R&D to Operations/QA.
The Director of Quality has the following Qualifications:
Bachelor's Degree in Biology, Chemistry, Engineering, or related life sciences fields.
Minimum of 12 years of experience in the pharmaceutical industry with at least 8 years in a leadership position.
Ideally has Aseptic solution experience/exposure
In-depth knowledge of FDA and international regulatory requirements and quality standards.
Strong problem-solving and analytical skills, with a track record of implementing effective quality improvement initiatives.
If you are interested in the role of Director of Quality, don't hesitate to apply today!