The Senior Quality Assurance Specialist is a senior-level quality leader responsible for strengthening regulatory compliance, investigator oversight, and inspection readiness across clinical research operations. This role provides strategic oversight of quality assurance initiatives, leads internal audits, mentors junior QA staff, and collaborates with cross-functional teams to drive continuous improvement in research quality and compliance.

Key Responsibilities

Regulatory Strategy & Oversight

• Maintain expert-level knowledge of FDA CFRs, ICH-GCP, and applicable regulatory frameworks.
• Interpret evolving regulatory requirements and translate them into operational practices.
• Provide regulatory risk guidance to leadership and site teams.

Audit & Inspection Leadership

• Plan and lead complex internal audits and mock FDA inspections.
• Oversee audit responses, CAPA development, and effectiveness checks.
• Serve as QA lead during sponsor, CRO, or regulatory inspections.
• Develop investigator-facing inspection readiness tools and frameworks.

Investigator Quality Partnership & Oversight

• Serve as the primary QA liaison to Principal and Sub-Investigators across assigned sites.
• Conduct investigator-focused quality reviews, including eligibility determinations, protocol compliance, safety oversight, and documentation integrity.
• Provide real-time compliance guidance to investigators and sub-investigators.
• Support investigator inspection readiness through targeted audit preparation and mock interviews.
• Identify trends in investigator-related deviations and develop corrective education plans.

Quality Systems & Governance

• Lead development and governance of SOPs and controlled documents.
• Drive enterprise-wide quality initiatives and infrastructure improvements.
• Ensure alignment between regulatory requirements and operational workflows.

Risk Management & CAPA Oversight

• Identify systemic and site-level quality risks.
• Conduct root cause analyses.
• Design and monitor CAPA plans, particularly those involving investigator oversight.

Mentorship & Leadership Development

• Mentor junior QA staff and provide structured onboarding support.
• Lead QA team training initiatives.
• Support performance coaching and skill development within the QA function.
• Participate in hiring, interviewing, and onboarding of QA personnel as delegated.

Data Integrity & Clinical Oversight

• Conduct advanced data integrity reviews and eligibility verifications.
• Evaluate protocol adherence across sites.
• Identify systemic data risks and implement preventive controls.

Strategic Reporting & Executive Communication

• Lead quality trend analysis and present findings to executive leadership.
• Provide investigator-level quality performance insights.
• Recommend strategic improvements to strengthen compliance and operational excellence.

Site Support & Travel

• Provide on-site audit support and facilitate onsite training, when required.
• Travel up to 40% as needed to support quality initiatives and inspections.

Additional Responsibilities

This job description outlines the primary responsibilities of the Senior Quality Assurance Specialist but is not intended to be exhaustive. Additional duties may be assigned as needed to support quality initiatives, audit preparation, onboarding improvements, operational consistency efforts, and broader organizational priorities. Responsibilities may evolve based on business needs, regulatory changes, and network growth.

Knowledge, Skills, and Competencies

• Deep expertise in FDA regulations, ICH-GCP, and clinical research compliance
• Strong understanding of investigator responsibilities under 21 CFR 312 and 812
• Demonstrated experience working directly with senior clinicians and operational leaders
• High-level risk assessment and decision-making capability
• Executive-level communication and presentation skills
• Strong mentoring and leadership potential
• Proficiency in EDC, CTMS, regulatory systems (e.g., Veeva, Complion, CRIO), and EMR platforms

Required Qualifications

• Bachelor’s degree required; advanced degree preferred
• Minimum of 5–7 years in clinical research with at least 3 years in a quality assurance leadership role.
• Experience leading FDA inspections, sponsor audits, or regulatory agency interactions. Certification in clinical research or quality (e.g., CCRA, RAC, ASQ) is a plus.