Associate Director, GCP Quality Assurance

Job Description

Job Description

Workforce Genetics is currently seeking an experienced GCP, Quality Assurance expert to work with a growing organization in Frederick, MD.

Depending on experience, this opportunity would be at the Associate Director or Director level. We're looking for a high-impact, hands-on leader to take the reins of the GCP Quality Assurance activities. This role is ideal for someone who thrives in a fast-paced, mission-driven environment and can immediately elevate clinical QA programs and manage the external audit program.

Key Responsibilities:

• Lead External Audit Program: Plan, execute, and oversee audits of clinical sites, CROs, and vendors
• Clinical Trial Oversight: Ensure GCP compliance across all phases of clinical development
• Pharmacovigilance QA: Monitor PV systems and ensure alignment with global regulatory standards
• Quality Systems Management: Maintain and enhance QMS, including SOPs, CAPAs, and deviation handling
• Inspection Readiness: Prepare teams and documentation for FDA, EMA, and other regulatory inspections
• Cross-Functional Leadership: Collaborate with Clinical Operations, Regulatory Affairs, and PV teams to drive a culture of quality and compliance

Basic Qualification:

• Bachelor's degree in a science discipline and an advanced degree preferred.
• 10+ years of experience in a Quality Assurance function within the pharmaceutical or biotech industry
• Minimum 8 years of direct GCP QA experience, including oversight of clinical trials and pharmacovigilance systems
• Proven track record of leading inspection readiness and audits for FDA, EMA, or other global regulatory bodies

This position will require an on-site presence in Frederick, MD

Pay will be based on experience with an hourly rate between 72-86/hr.