Head of Site Compliance

CSL Vifor; Holly Springs (NC); On-site; USD 110,000 - 150,000; Full time

Job summary

CSL Vifor in Holly Springs, NC, is seeking an experienced Quality Leader responsible for GMP/GxP compliance, site master file, and self-inspection program. You will oversee audits, inspections, and quality reviews, coordinating with global Compliance and Risk teams.

The role requires 7+ years in pharma quality with leadership and strong project management skills, within a global matrix setup. Advanced QA knowledge and regulatory familiarity are essential.

Qualifications

• 7+ years of experience in quality/GMP in the pharmaceutical/biotech industry, including 1–3 years in leadership.
• Experience within a global matrix organization.
• Demonstrated success in project management and QA systems.
• Knowledge of GMP/GQP regulatory requirements.
• Refer to local job documentation where applicable.

Responsibilities

• Complete the site master file and self-inspection program.
• Ensure site compliance with GMP/GxP standards and regulatory requirements.
• Manage local quality reviews, KPIs, and contribute to global quality reviews.
• Organize external regulatory, CSL corporate, and customer audits.
• Oversee preparation and readiness for regulatory inspections and third‑party audits.
• Manage inspection results, corrective actions, and timely responses to authorities.
• Perform gap assessments and coordinate site-based gap assessments.
• Liaise with global Compliance and Risk groups.
• Facilitate the site Change Control Review Panel and Deviation Review Board meetings.
• Prepare, facilitate and govern the site Quality Plan.

Skills

Quality Management

GMP Compliance

Leadership

Project Management

Regulatory Knowledge

Global Matrix

QA Systems

Education

Bachelor’s in Pharmacy/Chemistry/Biology

Advanced degree preferred

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.

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.