Site Quality Leader - CGMP, ISO 9001 & Compliance

Pacific International Executive Search; Midlothian (TX); On-site; USD 110,000 - 170,000; Full time

Job summary

Pacific International Executive Search seeks a Quality Manager for a flagship Dallas–Fort Worth area site. You will lead QA/QC, ensure CGMP compliance, and drive the Quality Management System while partnering with Operations, Regulatory, and Commercial teams.

You will manage a quality team, oversee audits, CAPA, deviations, and OOS investigations, and foster a culture of continuous improvement and data-driven decision making.

Qualifications

• Bachelor's degree in Chemistry, Engineering, or a related technical discipline, advanced degree preferred.
• 7+ years in a CGMP-regulated manufacturing environment (pharma, excipient, API, food, or specialty chemicals).
• 3+ years of leadership experience managing quality teams or systems.
• Strong working knowledge of ISO 9001, CGMP, SQF, and QMS.
• Hands-on analytical lab experience bridging chemistry with quality leadership.
• Proven success in audits, regulatory compliance, CAPA, investigations, and continuous improvement.
• Experience with structured root cause methods (5 Whys, Fishbone, 8D).
• Excellent communication and cross-functional influence across manufacturing, quality, commercial, and leadership teams.
• ASQ CQE, CQA, CMQ/OE certifications and Lean Six Sigma experience preferred.

Responsibilities

• Lead site QA and QC activities ensuring compliance with customer and regulatory requirements.
• Own development and continuous improvement of the Quality Management System (ISO 9001, CGMP, SQF).
• Serve as final authority for product quality decisions and investigations.
• Oversee CAPA, deviations, OOS investigations, and root cause analysis.
• Lead audits with customers, regulators, and certifications; maintain audit readiness.
• Partner with Operations, Regulatory Affairs, Supply Chain, and Commercial teams.
• Manage and develop a team of quality professionals; promote collaboration.
• Drive customer complaint investigations and implement corrective actions.
• Provide leadership for laboratory operations, testing, and product release.
• Analyze quality metrics, identify risks, and drive improvements.
• Champion use of quality tools and data analytics; sustain improvements.
• Maintain presence across the facility to engage employees at all levels.

Skills

Leadership

Quality leadership

Audits

Regulatory knowledge

Cross-functional collaboration

Data analytics

Education

Bachelor's in Chemistry/Engineering

Advanced degree preferred

Tools

Quality Management System (QMS)

Job description

Pacific International Executive Search seeks a Quality Manager for a flagship Dallas–Fort Worth area site. You will lead QA/QC, ensure CGMP compliance, and drive the Quality Management System while partnering with Operations, Regulatory, and Commercial teams.

You will manage a quality team, oversee audits, CAPA, deviations, and OOS investigations, and foster a culture of continuous improvement and data-driven decision making.