Sr Manager, Clinical Quality Compliance

Responsibilities

• Serve as quality lead for clinical studies, guiding GCP compliance
• Lead Study Risk Assessment process and inspection readiness activities
• Conduct investigations, root cause analyses, and manage CAPAs
• Collaborate with stakeholders to evaluate and escalate quality risks
• Partner with teams for documentation and audit/inspection planning
• Support audit planning and regulatory inspection preparation
• Participate in cross-functional initiatives to enhance quality systems

Qualifications

• Bachelor's degree required
• 5+ years' experience in clinical research, quality, or compliance
• Strong knowledge of GCP and global clinical regulations (ICH, CFR, EU)
• Hands-on GCP Quality and inspection experience required
• Proven track record managing CAPAs and conducting investigations
• Knowledge of clinical trial systems, metrics, and risk management
• Excellent communication, facilitation, and decision-making skills

Benefits

• Comprehensive medical, dental, vision, and life insurance
• Fitness and wellness programs with fitness reimbursement
• Short- and long-term disability insurance
• Minimum 15 days of paid vacation plus end-of-year shutdown
• 12 paid holidays and 3 personal significance days off
• 80 hours of sick time each year
• Paid maternity and parental leave benefits
• 401(k) with company matching contributions
• Employee stock purchase plan available
• Annual tuition reimbursement up to $10,000
• Participation in Employee Resource Groups

Pay

$134,000 – $179,000 annually

Schedule

Remote - US based candidates only, no visa sponsorship available

Skills

N/A

Requirements

N/A