Validation Consultant

A global pharmaceutical manufacturer specialising in sterile injectables and ophthalmic drug products is seeking a Contract Head of Validation to lead site-wide validation strategy at their North Carolina facility.

The site manufactures high-quality liquid and semi-solid sterile products for regulated markets, operating within a complex GMP environment that includes aseptic processing, filling lines, sterilisation systems, clean utilities, and laboratory operations.

This is a senior leadership assignment requiring both strategic oversight and hands-on technical authority across CQV, process validation, cleaning validation, and continued process verification.

You will hold ultimate accountability for validation compliance and execution across:

• Aseptic filling lines and isolator/RABS systems
• Sterilisation (autoclaves, dry heat, SIP systems)
• Clean utilities (WFI, clean steam, compressed gases)
• HVAC and classified cleanroom environments
• Process validation (PPQ) and cleaning validation
• Equipment qualification (IQ/OQ/PQ)
• Data integrity and lifecycle validation governance

Why This Role Is Critical

• The site is undergoing operational expansion and validation programme strengthening
• Regulatory expectations for sterile manufacturing continue to increase (FDA, EU GMP Annex 1 alignment)
• Strong validation leadership is required to ensure audit readiness, inspection confidence, and sustainable lifecycle control

Failure to strengthen validation governance could expose the site to compliance risk, delayed product release, and regulatory scrutiny.

Key Responsibilities

• Own and execute the site Validation Master Plan (VMP)
• Lead and develop validation teams across CQV and lifecycle validation
• Ensure validation strategy aligns with current regulatory expectations and inspection trends
• Interface directly with QA leadership and site executive team
• Provide oversight for deviation management, CAPA effectiveness, and risk-based validation approaches
• Drive continuous improvement in validation efficiency without compromising compliance
• Act as primary validation SME during regulatory inspections

Ideal Profile

• 15+ years’ experience in pharmaceutical validation within sterile manufacturing
• Proven leadership experience as Head of Validation / Validation Director level
• Strong knowledge of aseptic processing and Annex 1 expectations
• Deep understanding of FDA inspection readiness and regulatory interaction
• Demonstrated success leading validation remediation or transformation programmes
• Confident executive presence with ability to influence cross-functional stakeholders