Senior QA Leader — Clinical GxP & Compliance

IQVIA; Indianapolis (IN); On-site; USD 89,000 - 247,000; Full time

Job summary

IQVIA is seeking a strategic Quality Assurance leader to oversee QA programs across clinical research, GxP-regulated activities, and regulatory compliance. The role focuses on risk-based decision making, patient safety, and operating with global quality governance in mind.

The ideal candidate has extensive CQA experience, deep GCP/GxP knowledge, and a proven ability to manage audits, CAPA processes, and cross-functional initiatives across multiple regions.

Qualifications

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, Healthcare Administration, Biology, Chemistry, or related field preferred
• Minimum of 10 years of Quality Assurance experience in pharma/biotech/CRO/medical device/clinical research environments
• Extensive experience interpreting and overseeing GCP standards in clinical research
• Experience leading audits, CAPA activities, and quality initiatives is advantageous
• Proven ability to influence stakeholders across functions and levels

Responsibilities

• Serve as primary QA liaison for assigned customers, sponsors, and clinical operations groups
• Provide QA oversight of deviations, CAPAs, risk assessments, and compliance initiatives
• Act as SME in GCP, GxP, ICH guidelines and pharmaceutical quality requirements
• Guide regulations and quality expectations to clinical and operational teams
• Support inspection readiness and regulatory inspections and sponsor/customer audits
• Contribute to QA policy, SOPs, risk management and global governance initiatives
• Develop and maintain CAPA plans and assist in investigations and reporting
• Analyze audit trends and quality indicators to drive process improvements

Skills

GxP Compliance

Audits & CAPA

Quality Assurance Leadership

GCP Knowledge

Regulatory Guidance

Education

Bachelor’s degree in Life Sciences/related field

Job description

IQVIA is seeking a strategic Quality Assurance leader to oversee QA programs across clinical research, GxP-regulated activities, and regulatory compliance. The role focuses on risk-based decision making, patient safety, and operating with global quality governance in mind.

The ideal candidate has extensive CQA experience, deep GCP/GxP knowledge, and a proven ability to manage audits, CAPA processes, and cross-functional initiatives across multiple regions.