Associate Director, Clinical Quality (Remote Eligible)

About the role

This role will shape clinical quality strategy across study execution efforts, with a strong focus on GCP compliance, risk management, and inspection readiness. You will partner closely with cross-functional and site teams to strengthen quality maturity, support vendor oversight, and help ensure clinical programs are executed in alignment with regulatory expectations. The position also plays a key role in identifying compliance gaps, driving CAPA activities, and building effective quality processes in a highly matrixed environment.

Responsibilities

• Lead GCP quality strategy on assigned study execution teams
• Collaborate with site and cross-functional leaders to enhance quality maturity
• Conduct proactive quality risk assessments and develop mitigation strategies
• Oversee risk-based monitoring and resolution of quality issues with regulatory alignment
• Manage the inspection strategy and interactions with regulatory authorities
• Identify compliance gaps, lead root cause analysis, and direct CAPA processes
• Evaluate and oversee CROs and clinical vendors for quality compliance

Qualifications

• 12+ years of related experience
• Bachelor's degree or equivalent combination of education and experience
• Experience developing, implementing, or improving Quality Management Systems
• Strong knowledge of ICH E6 GCP guidelines and FDA regulations
• Experience supporting regulatory inspections, including FDA and EMA
• History of providing quality oversight of CROs and clinical vendors
• Ability to influence teams and lead strategic quality initiatives in a matrix environment
• Excellent communication and critical-thinking skills

Benefits

• Comprehensive 401k plan
• Healthcare coverage
• Employee Stock Purchase Plan (ESPP)
• Broad range of additional benefits

Pay

$171,000 – $223,000 annually

Schedule

Remote – US based candidates only, no visa sponsorship available