Senior Validation Lead - Risk-Based C&Q for Biologics

United Consulting Hub; New York (NY); On-site; USD 140,000 - 190,000; Full time

Job summary

United Consulting Hub is seeking a Validation Lead to drive risk-based validation strategy and regulatory compliance for a major greenfield pharmaceutical manufacturing program in New York. You will lead validation strategy and compliance, implementing ASTM E2500, and interface with quality and regulatory stakeholders to ensure inspection readiness and documentation compliance.

The role requires proven risk-based C&Q leadership on large blue-chip pharma projects and a strong background in GAMP

Qualifications

• Strong GAMP and DeltaV qualification background.
• Proven risk-based C&Q leadership on greenfield biologics/pharma projects.
• Experience with large capital pharma or biotech project delivery.

Responsibilities

• Provide validation strategy and compliance leadership.
• Drive risk-based validation approaches and ASTM E2500 implementation.
• Interface with quality and regulatory stakeholders.
• Ensure inspection readiness and documentation compliance.
• Lead qualification philosophy and data integrity alignment across the program.

Skills

GAMP

DeltaV

Risk-based validation

Regulatory compliance

Data integrity

Stakeholder interface

Tools

ASTM E2500

Job description

United Consulting Hub is seeking a Validation Lead to drive risk-based validation strategy and regulatory compliance for a major greenfield pharmaceutical manufacturing program in New York. You will lead validation strategy and compliance, implementing ASTM E2500, and interface with quality and regulatory stakeholders to ensure inspection readiness and documentation compliance.

The role requires proven risk-based C&Q leadership on large blue-chip pharma projects and a strong background in GAMP