Associate Director, QA Lead - Drug Product - Dundalk

Are you passionate about quality assurance and have a strong background in GMP production? We invite you to join our team as a QA Lead, Associate Director. In this role, you will be pivotal in ensuring our GMP production quality system meets all regulatory, cGMP, and company requirements. Your expertise will uphold our high standards of quality and contribute to the success of our programs. If you are dedicated to excellence in quality assurance, we welcome your application to be part of our innovative team. 

Your Core Responsibilities 

• Act as site QA responsible for onsite quality monitoring of DP manufacturing and participate in GMP production activities. 
• Monitor the construction quality of GMP production and support CQV activities as necessary. 
• Create department SOPs in collaboration with functional departments, ensuring alignment with corporate policies. 
• Audit quality documents to ensure data integrity and provide QA guidance. 
• Support site GMP Readiness preparation activities, including the internal self-inspection program. 
• Establish and manage the DP QA team, providing online support and ensuring performance management requirements are met. 
• Review and approve manufacturing-generated documents, ensuring compliance with regulatory standards. 
• Liaise with cross-functional teams for DP release and prepare necessary documentation for QP release. 

Who You Are 

You are ready if you have: 

• Qualification Degree in Biopharmaceutical Science or other related science discipline. 
• Knowledge of legislative, regulatory, market and data integrity requirements. 
• Relevant experience in vaccine/biopharma or similar pharma/science background. 
• Proven track record in people management, problem-solving, and interpersonal skills. 
• Proven ability to lead continuous improvement initiatives to enhance quality standards and operational efficiency within the QA team. 
• Exceptional skills in collaborating with cross-functional teams to integrate QA processes and address issues promptly. 
• Strong leadership skills, including strategic planning, innovation, and talent development, with a commitment to diversity, equity, and inclusion. 
• Strong communication skills with the ability to work in a matrix environment.