Associate Director, GCP Compliance

Position

Description:

This role can be remote, hybrid or based in Philadelphia, PA headquarters. Reporting to the Senior Director, GCP Quality & Compliance, the Associate Director, GCP Compliance leads the design, implementation, and continuous improvement of a risk-based Quality Management System (QMS) aligned to ICH GCP E6(R3). Ensures oversight of controlled documentation, training, vendor quality, TMF health, and inspection readiness.

• Build and maintain a risk-based QMS aligned with E6(R3), emphasizing Critical-to-Quality (CtQ) factors.
• Manage controlled document life cycles (SOPs, WIs, forms).
• Oversee GxP computerized systems for ALCOA++ compliance (validated configurations, secure audit trails).
• Own role-based training curricula and ensure training effectiveness.
• Lead deviation management, CAPAs, and root cause analysis; perform trend analyses.
• Drive TMF oversight and inspection readiness (risk-based QC, completeness checks, metrics).
• Provide proportionate vendor/CRO oversight; define quality agreements and monitor audit outcomes.
• Align clinical (GCP) and manufacturing (GMP) documentation for traceability and record integrity.
• Develop QMS performance indicators and report during management reviews.
• Promote a culture of quality focused on patient safety and operational transparency.

• Bachelor’s degree in a scientific discipline.
• 5-7 years in GxP quality/compliance; 2+ years in leadership or document control.
• Proven ICH GCP E6(R3) implementation experience.
• Experience with TMF management, CAPA systems, and inspection readiness.
• Strong understanding of GCP/GMP interfaces and regulatory expectations.
• Experience working with a CRO as a sponsor (preferred).
• Ability to work independently in a fast-paced environment; strong communication and cross-functional skills.
• Biotech/startup experience preferred.

• competitive benefits, PTO, and stock option plans.