Site Quality & GMP Compliance Director

CSL; Holly Springs (NC); On-site; USD 90,000 - 150,000; Full time

Job summary

CSL is seeking an experienced Quality Leader to ensure GMP/GxP compliance, manage site quality programs, and support global quality reviews. You will organize audits, drive corrective actions, and liaise with global Compliance and Risk teams for continuous improvement.

Ideal candidates bring 7+ years in pharma/biotech quality with leadership experience, strong project management, and knowledge of GMP/GQP regulations, within a global matrix organization.

Qualifications

• Degree in Pharmacy, Chemistry, Biology or Biochemistry; advanced degree preferred.
• 7+ years in quality/GMP within pharma/biotech including 1–3 years in leadership.
• Experience within a global matrix organization.
• Proven project management and QA systems experience.
• Knowledge of GMP/GQP regulatory requirements.

Responsibilities

• Complete the site master file and self-inspection program and ensure GMP/GxP compliance.
• Organize external regulatory, CSL corporate, and customer audits and readiness for inspections.
• Manage inspection results and timely responses to authorities.
• Facilitate the site Change Control Review Panel and the Deviation Review Board meetings.
• Prepare, facilitate and govern the site Quality Plan.
• Coordinate site-based gap assessments and liaise with global Compliance and Risk groups.

Skills

Quality/GMP experience

Leadership experience

Project management

QA systems knowledge

Education

Bachelor's degree in Pharmacy/ Chemistry/ Biology/ Biochemistry

Job description

CSL is seeking an experienced Quality Leader to ensure GMP/GxP compliance, manage site quality programs, and support global quality reviews. You will organize audits, drive corrective actions, and liaise with global Compliance and Risk teams for continuous improvement.

Ideal candidates bring 7+ years in pharma/biotech quality with leadership experience, strong project management, and knowledge of GMP/GQP regulations, within a global matrix organization.