Senior QA & Compliance Lead - Clinical Research

Baylor College of Medicine; Houston (TX); Hybrid; USD 79,000 - 93,000; Full time

Job summary

Baylor College of Medicine in Houston, TX is seeking a Senior Quality Assurance and Control Associate to provide independent quality oversight of clinical research. The role focuses on FDA/ICH-GCP compliance, audits, and regulatory inspections, ensuring accuracy and integrity of study documentation with ongoing readiness.

The position is hybrid, typically requiring two days per week in the office, with certification pay available for CCRP/CCRC holders and opportunities for training and process

Qualifications

• Bachelor's degree required.
• Four years of relevant experience required.
• Experience in clinical research quality assurance and regulatory compliance is preferred.

Responsibilities

• Provide independent, risk-based quality oversight of clinical research activities to ensure FDA/ICH-GCP compliance.
• Lead and support internal audits, sponsor audits, and regulatory inspections including FDA inspections.
• Oversee CAPA development and effectiveness checks to ensure corrective action.
• Contribute to education initiatives and investigator training on GCP and regulatory expectations.
• Maintain audit readiness and assist in documentation/registrations as needed.

Skills

Quality assurance

Regulatory compliance

Audit oversight

FDA inspections

Documentation

CAPA programs

Education

Bachelor's degree

Job description

Baylor College of Medicine in Houston, TX is seeking a Senior Quality Assurance and Control Associate to provide independent quality oversight of clinical research. The role focuses on FDA/ICH-GCP compliance, audits, and regulatory inspections, ensuring accuracy and integrity of study documentation with ongoing readiness.

The position is hybrid, typically requiring two days per week in the office, with certification pay available for CCRP/CCRC holders and opportunities for training and process