Site Quality & Compliance Leader

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

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.