Quality Director, Manufacturing Operations

Job Description

Agilent is seeking an experienced and visionary Quality Director to serve as the Site Quality Head for our Cedar Creek site, which manufactures and distributes products for multiple divisions within the Diagnostics and Genomics Group. This critical leadership role will oversee all aspects of quality operations at the site and manage the Center of Excellence global efforts for LDG’s Operational Excellence program. The successful candidate will drive continuous improvement using Lean methodologies and ensure that all quality management systems align with national, regional, and global regulatory standards.

Key Responsibilities:

• Quality Operations Leadership:

  • Oversee quality operations, supplier quality, quality engineering, and all related functions, including field actions, product investigations, and complaint investigations.

  • Manage document control, change control, training programs, non-conformances, deviations, CAPA, and management reviews.

• Regulatory Compliance & GMP Oversight:

  • Act as the GMP quality leader for the Cedar Creek site, ensuring that all products are designed, manufactured, and distributed in compliance with applicable regulations and Agilent policies.

  • Translate complex regulatory requirements into practical, actionable plans and host internal audits and external inspections.

• Operational Excellence & Lean Implementation:

  • Lead and manage the Center of Excellence global efforts for LDG’s Operational Excellence program, integrating Lean methodologies such as System Thinking, Value Stream Mapping, Kaizen, and Problem Solving across the organization.

  • Develop, execute, and manage tactical business plans and multi-business programs that drive strategic goals and continuous improvement.

• Quality Management Systems & Metrics:

  • Ensure that quality management system procedures are accurate, current, and assessed regularly via dashboards and performance metrics.

  • Monitor audits of production, quality control areas, and raw material vendors to maintain high standards.

• Team Leadership & Change Management:

  • Build and lead high-performing quality teams, fostering collaboration across manufacturing, R&D, distribution, and quality functions.

  • Act as a change agent to promote a customer-centered culture, supporting training, career development, and effective communication within the organization.

• External Representation:

  • Represent Agilent in industry associations, standards bodies, and interactions with regulatory agencies.

Qualifications

Education & Experience:

• Bachelor’s degree required

• 10+ years of Quality leadership experience in the medical device and/or in vitro diagnostic industry

• 5+ years in a management role

Technical Expertise:

• Deep knowledge of regulated healthcare environments, GMP, and cross-functional business acumen.

• Proven experience with data collection, analysis, and reporting technologies.

Lean & Operational Excellence:

• Demonstrated expertise in Lean thinking and tools (System Thinking, Value Stream Mapping, Kaizen, and Problem Solving).

• Proven track record of implementing Operational Excellence initiatives that drive measurable improvements.

Leadership & Strategic Thinking:

• A visionary and strategic thinker with a strong ability to collaborate and influence cross-functional teams.

• Demonstrated success in rebuilding organizations and guiding transformational change within Quality.

Interpersonal Skills:

• Exceptional relationship development, conflict resolution, and team-building skills, with the ability to build robust partnerships both internally and externally.

Travel:

• Willingness to travel domestically and internationally (~20%).

The successful candidate will be instrumental in ensuring that Agilent continues to deliver safe, reliable, and compliant products while driving a culture of continuous improvement and operational excellence.

Additional Details

This job has a full time weekly schedule. Applications for this job will be accepted until at least March 12, 2025 or until the job is no longer posted.

The full-time equivalent pay range for this position is $150,000.00 - $234,375.00/yr plus eligibility for bonus, stock and bene