Lead the development and execution of the quality assurance strategy for the West, Indiana site, overseeing all aspects of quality systems, compliance, assurance, control, and continuous improvement
Job Summary
Lead the development and execution of the quality assurance strategy for the West, Indiana site, overseeing all aspects of quality systems, compliance, assurance, control, and continuous improvement.
As an integral member of the Site Leadership Team, align quality initiatives with business objectives and operational performance goals, fostering a culture of quality, continuous improvement, and operational excellence.
This position demands transformational leadership on a rapidly growing campus recognized as a center of excellence with significant expansion plans, requiring strong engagement with local and global leaders.
Matching Summary
Lead the development and execution of the quality assurance strategy for the West, Indiana site, overseeing all aspects of quality systems, compliance, assurance, control, and continuous improvement.
Skills & Requirements
Must-have
Lead quality assurance strategy
Oversee quality systems and compliance
Ensure adherence to GMP and ISO 13485
Manage drug packaging and combination products
Maintain readiness for regulatory inspections
Nice-to-have
Foster a culture of quality excellence
Drive innovation and continuous improvement
Build strong customer relationships
Adapt to fast-paced, evolving environments
Key Requirements
Minimum of 10 years of Quality/Regulatory management
Proven experience in Medical Device, Pharmaceutical Packaging and Combination Products regulations
Bachelor’s Degree in Quality, Engineering, Life Sciences or equivalent experience