Head of Site Compliance

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

Responsibilities

The role holder is responsible for completing the site master file and self-inspection program, ensuring site compliance with GMP/GxP standards and regulatory requirements, and managing local quality reviews, KPIs, and contributing to global quality reviews. They provide impartial quality oversight and work closely with the FLQA organization.

Responsibilities

The role holder is responsible for completing the site master file and self-inspection program, ensuring site compliance with GMP/GxP standards and regulatory requirements, and managing local quality reviews, KPIs, and contributing to global quality reviews. They provide impartial quality oversight and work closely with the FLQA organization.

Additionally, they organize and facilitate external regulatory, CSL corporate, and customer audits, oversee preparation and readiness for regulatory inspections and third-party audits, and manage inspection results, corrective actions, and timely responses to authorities.

They also perform gap assessments, evaluate site compliance with audit outputs and regulatory changes, coordinate site-based gap assessments, and liaise with global Compliance and Risk groups.

The role holder is responsible for facilitation of the site Change control review panel and the site Deviation Review Board meetings, as assigned.

The role holder is responsible for preparation, facilitation and governance of the site Quality Plan.

Qualifications

• Degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry); advanced degree preferred
• 7+ years' experience in quality/GMP in the pharmaceutical/biotech industry including 1-3 years' leadership/team management experience
• Experience within a global matrix organization
• Demonstrated success in project management and business/QA systems
• Knowledge of appropriate regulatory requirements including GMP/GQP

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.