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As a Site Quality Head, you will lead the Cartago, Costa Rica plant quality team, ensuring systems, processes, and procedures for regulatory compliance. You will also serve as the Management Representative for the plant, strategizing to meet measurable quality objectives and goals while supporting the manufacturing of IV sets. You will be part of the plant's Senior Leadership Team and oversee a quality team of 50+ indirect reports.
Job Responsibility:
Responsible for the outgoing safety, quality, and efficacy of all finished products manufactured at the site
ensuring the quality system processes are effectively established and maintained in accordance with applicable regulations, standards, and Baxter Quality System requirements
ensuring and maintaining the GMP compliance status for their sites, per the applicable regulations and relevant GMP activities
establishing and maintaining an environment that encourages partnership and collaboration
coaching, training, and developing the quality team (50+ indirect reports).
Requirements:
BS degree in Science or Engineering required
10+ years related work experience in Quality, Manufacturing, or related field in a Medical Device/Pharmaceutical Industry
7+ years of management-level experience
ability to handle multiple projects concurrently
computer experience
knowledge of local regulations and application of Good Manufacturing Practices (GMP).
Nice to have:
collaborative mindset
resilience
ability to strategize
experience coaching, training, and developing teams.
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