Global Quality Audit & Compliance Lead

Grifols; United States; Remote; USD 77,000 - 116,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

PTO

401(k) match

Job summary

Grifols seeks a Quality Audit Specialist to lead audit and regulatory compliance across donor centers and corporate functions in the U.S. You will prepare Site Master Files, support EMA/FDA inspections, and develop robust audit responses and CAPA plans to meet regulatory expectations.

The role requires coordinating cross-functional teams, delivering accurate documentation, and driving continuous improvement while traveling up to 50% as needed.

Qualifications

• Must understand the CFR as it applies to Source Plasma.
• Must know the European Pharmacopoeia and its interaction with CFR and SOPs.
• Must know CLIA/COLA/PPTA regulations as they apply to Source Plasma and support inspections as needed.

Responsibilities

• Lead and coordinate audit and compliance activities, including QAMS reviews and inspections.
• Develop Site Master Files (SMFs) for external EMA inspections.
• Deliver on-site and remote support during regulatory inspections.
• Prepare external audit responses and CAPA plans addressing citations.
• Coordinate final regulatory inspection responses for FDA, EMA and other agencies.
• Support donor centers with audits and documentation requests.
• Identify systemic improvement opportunities from audit findings and drive corrective actions.
• Travel up to 25% or more as required.

Skills

CFR knowledge

EP knowledge

Regulatory knowledge

Audit management

Job description

Grifols seeks a Quality Audit Specialist to lead audit and regulatory compliance across donor centers and corporate functions in the U.S. You will prepare Site Master Files, support EMA/FDA inspections, and develop robust audit responses and CAPA plans to meet regulatory expectations.

The role requires coordinating cross-functional teams, delivering accurate documentation, and driving continuous improvement while traveling up to 50% as needed.