Global Quality Audit Lead, Regulatory Compliance

Grifols; Kansas; Hybrid; USD 77.000 - 116.000; Vollzeit

Benefits dieser Stelle

Medical insurance

Dental insurance

Vision insurance

Life insurance

Paid time off

Zusammenfassung

Grifols seeks a Quality Audits Specialist to lead regulatory inspection responses and CAPA activities across donor centers. You will oversee PMFs and external audit processes, ensuring compliance with FDA, EMA, CLIA/COLA, PPTA, and state authorities while collaborating with cross-functional teams.

Role requires strong CFR/EP knowledge, experience with audits, and ability to travel up to 50% to support inspections and audits across North America and Europe.

Qualifikationen

• Bachelor's degree in a related field.
• Minimum 5 years experience in quality assurance or QA regulatory environments.
• Experience with regulatory inspections and audit responses is required.

Aufgaben

• Lead development of Site Master Files (SMFs) for external EMA inspections.
• Represent the organization during regulatory inspections (on-site and remote).
• Develop, author, and review external audit responses and CAPA plans for donor center citations.
• Develop and review internal and external audit responses and CAPA plans for corporate citations.
• Coordinate and author final regulatory inspection responses for agencies (FDA, EMA, CLIA/COLA, PPTA, State authorities, Health Canada).
• Provide support to donor centers by overseeing customer audits and delivering documentation.

Kenntnisse

Regulatory compliance

Quality audits

CFR knowledge

CAPA management

SOP development

Communication

Ausbildung

Bachelor's degree

Jobbeschreibung

Grifols seeks a Quality Audits Specialist to lead regulatory inspection responses and CAPA activities across donor centers. You will oversee PMFs and external audit processes, ensuring compliance with FDA, EMA, CLIA/COLA, PPTA, and state authorities while collaborating with cross-functional teams.

Role requires strong CFR/EP knowledge, experience with audits, and ability to travel up to 50% to support inspections and audits across North America and Europe.