MSD Associate Director QA Lead - Drug Product Dundalk 

Ireland 

214740020

Associate Director. In this role, you will be pivotal in ensuring our GMP production quality system meets all regulatory, cGMP, and company requirements. Yourwill uphold ourhigh standards

Your Core Responsibilities

• Act as site QA responsible for onsite quality monitoring of DP manufacturing andparticipatein GMP production activities.

• Monitor the construction quality of GMP production and support CQVactivitiesas necessary.

• Create department SOPs in collaboration with functional departments, ensuring alignment with corporate policies.

• Audit quality documents to ensure data integrity andprovideQA 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

• 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.

• track recordin 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.

• Aprocesses and address issues promptly.

• Strong leadership skills, including strategic planning, innovation, and talent development, with a commitment to diversity, equity, and inclusion.

• Strong communicationskills with the ability to work in a matrix environment.