Manager, QA Validation (Sterile Manufacturing)

Key Responsibilities

• Develop risk-based qualification/validation strategy to support the activities
• Support generation, review and approval of validation deliverables such as plans, protocols and reports (supporting equipment, facility, utility, computerized systems and processes)
• Supervise validation engineers/specialists (direct or contract) ensuring high technical competency and adherence to cGMP.
• Provide QA oversight for validation activities including process validation, cleaning validation, equipment qualification (IQ/OQ/PQ), utility qualification, and computer system validation.
• Oversee validation activities related to aseptic processing, sterilization (e.g., autoclaves, dry heat ovens), and environmental monitoring systems.
• Evaluate and support qualification of cleanrooms, HVAC systems, compressed gases, WFI, and clean steam.
• Participate in aseptic process simulations (media fills) and ensure validation readiness.
• Support validation of formulation processes, sterile filtration, container closure systems, and visual inspection technologies.
• Assess validation impact for changes to equipment, components, formulations, or process parameters.
• Identify opportunities to optimize fill–finish validation strategies while maintaining compliance and product quality.
• Contribute to development and revision of SOPs, templates, and quality standards related to aseptic processing and fill–finish validation.

Quality Systems and Compliance

• Apply Quality Risk Management (ICH Q9) principles to validation strategies and decisions.
• Support investigations related to validation deviations, equipment failures, or sterility assurance risks.
• Ensure validation activities align with FDA, EMA, ICH, Annex 1, and industry best practices for sterile and fill–finish operations.
• Support regulatory inspections and internal audits, serving as the subject matter expert for validation.

Required Qualifications/Skills

• Bachelor’s or master’s degree in engineering, Life Sciences, or related field.
• 8+ years of experience (6+ years for master’s degree) in validation/QA within a GMP sterile manufacturing or fill–finish environment.
• 3+ years of experience in people management (direct or contract).
• Strong understanding of aseptic processing, sterilization, contamination control, fill–finish and packaging operations.
• Working knowledge of validation lifecycle principles, risk management, and data integrity requirements.
• Familiarity with regulatory expectations including FDA, EMA, ICH Q7–Q10, and EU Annex 1.
• Excellent communication, documentation, and cross functional collaboration skills.

Preferred Qualifications

• Experience with isolator‑based sterility testing and aseptic filling technologies.
• Experience supporting regulatory inspections (FDA, EMA, MHRA).
• Leverage/Six Sigma or continuous improvement training.

Pay Range

$116,000 - $174,000 per year