Senior Director, GCP Quality Assurance Lead – Remote

Embedded Shishya; United States; Remote; USD 180,000 - 280,000; Full time

Job summary

Prilenia Therapeutics is seeking a Director/Senior Director, GCP Quality Assurance Lead to own end-to-end GCP quality for Phase 3 clinical programs in HD and ALS. The role reports to senior leadership and partners with Clinical Development, Regulatory Affairs, Drug Safety, and Biostatistics.

The candidate combines hands-on QA with strategic oversight, ensuring inspection readiness and strong CRO/supplier governance in a fast-moving biotech environment.

Qualifications

• Minimum 10 years of GCP QA experience.
• Leadership experience at biotech or CRO.
• Deep knowledge of ICH/E6, ICH E2 series, FDA CFR Parts 11/50/54/56/312.

Responsibilities

• Lead GCP quality end-to-end from study start-up to inspection readiness.
• Act as sponsor QA counterpart to CRO QA teams and Ferrer's QA.
• Oversee eTMF quality, CAPA resolution, and regulatory commitments.
• Author and maintain GCP SOPs; define quality metrics for leadership.
• Mentor junior QA staff and foster development.

Skills

GCP QA expertise

Audits & inspections

Cross-functional leadership

Regulatory knowledge (ICH/E6, GvP, GLP

Education

Bachelor’s degree in life sciences or related

Advanced degree preferred (MSc/PharmD)

Tools

eTMF systems (Veeva Vault)

Electronic QMS platforms

Job description

Prilenia Therapeutics is seeking a Director/Senior Director, GCP Quality Assurance Lead to own end-to-end GCP quality for Phase 3 clinical programs in HD and ALS. The role reports to senior leadership and partners with Clinical Development, Regulatory Affairs, Drug Safety, and Biostatistics.

The candidate combines hands-on QA with strategic oversight, ensuring inspection readiness and strong CRO/supplier governance in a fast-moving biotech environment.