Director / Senior Director, GCP Quality Assurance Lead (US/IL/EU)

Qualifications

• 10+ years of GCP QA experience within the pharmaceutical, biotechnology, or CRO industry
• 3+ years in a leadership or director-level role at a biotech company
• Demonstrated expertise across GCP, GvP, and GLP quality frameworks; hands-on experience conducting and managing audits in all three domains
• Proven experience leading or managing regulatory authority inspections (FDA, EMA, MHRA, or equivalent) to successful outcomes
• Experience building or significantly maturing a QMS in a small-to-mid-size pharmaceutical setting

Skills

Leadership skills, regulatory compliance knowledge, audit management, inspection handling, quality system development.

Benefits

Competitive compensation package, comprehensive benefits, professional development opportunities, remote work option.

Pay

Negotiable based on experience and qualifications.

Schedule

Full-time, remote work.