This leadership role involves managing and executing validation projects to ensure compliance with customer and regulatory standards, including FDA, GAMP, and ISO.
Responsibilities include evaluating systems, designing validation strategies, coordinating validation activities for software and processes, and maintaining thorough documentation.
Candidates should have a Bachelor’s degree in Engineering, Quality, Business, or Computer Science, with 5+ years in Manufacturing, Quality, or Engineering, and 3+ years in GAMP 5 validation.
Experience in medical device QMS, project management, and process improvement is preferred.
Salary ranges from $101,000 to $152,000 annually, plus benefits, with opportunities for growth and inclusion.
This role requires strong leadership, communication, and regulatory knowledge to ensure successful validation outcomes.