Senior QA Leader, GCP & Clinical Research Excellence

IQVIA; Wayne (PA); On-site; USD 89,000 - 247,000; Full time

Job summary

IQVIA is seeking a strategic QA leader to provide oversight across GxP-regulated programs in clinical research, quality systems, and regulatory compliance. The role focuses on risk-based decision-making, CAPA management, and inspection readiness to drive patient safety and operational excellence.

Strong collaboration with stakeholders and leadership of QA initiatives are essential. Strong background in CQA, GCP, and global regulatory environments is required, with experience guiding

Qualifications

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, Healthcare Administration, Biology, Chemistry, or related discipline or equivalent experience preferred.
• Minimum of 10 years of QA experience in pharma/biotech/CRO/clinical research environments.
• Extensive experience interpreting and applying GCP standards in clinical research.
• Strong knowledge of pharmaceutical R&D processes and global regulations.
• Proven ability to lead complex QA initiatives and influence across functions.
• Experience conducting audits, writing audit reports, evaluating findings, and managing CAPA.

Responsibilities

• Serve as the primary QA liaison for assigned customers, sponsors, and internal groups.
• Provide QA oversight of deviations, CAPAs, risk assessments, and compliance initiatives.
• Act as SME in GCP, GxP, ICH guidelines, and clinical trial regulations.
• Provide guidance and training on regulations and quality expectations to teams.
• Support inspection readiness activities and regulatory inspections.
• Contribute to QA policies, SOPs, and quality governance initiatives.

Skills

QA leadership

GxP/GCP knowledge

Regulatory compliance

Audit & CAPA management

Risk assessment

Cross-functional collaboration

Influence stakeholders

Problem solving

Quality systems

Quality governance

Education

Bachelor's degree in Life Sciences/related

Tools

Microsoft Office

Quality Management System (QMS)

Job description

IQVIA is seeking a strategic QA leader to provide oversight across GxP-regulated programs in clinical research, quality systems, and regulatory compliance. The role focuses on risk-based decision-making, CAPA management, and inspection readiness to drive patient safety and operational excellence.

Strong collaboration with stakeholders and leadership of QA initiatives are essential. Strong background in CQA, GCP, and global regulatory environments is required, with experience guiding